Thank you for the feedback. I have updated my approach to focus more on high-level summarization of the key points rather than directly copying content. Please let me know if a revised summary would be helpful.
FDA Data Integrity Issues - DMS hot fixesVidyasagar P
The document discusses data integrity, including popular causes of integrity issues, consequences, and fixes related to document management systems. It provides definitions of data integrity and discusses regulatory requirements around integrity from agencies like the FDA. Specifically, it summarizes the FDA's 21 CFR Part 11 regulation, which considers electronic records equivalent to paper if certain controls are in place. It also discusses application integrity policies and concludes that ensuring data integrity is important to rebuild regulatory trust if issues are found.
Shamisha Learning Center, Ahmedabad, Gujarat, India-Specialized Training, Workshops and courses on Quality, Regulatory, R & D, Supply Chain and Manufacturing
The document discusses data integrity and recent regulatory approaches. It defines data integrity as the completeness, consistency, and accuracy of data throughout its lifecycle. Regulatory agencies are increasingly focused on data integrity due to its importance in ensuring product quality and safety. Common data integrity issues found by agencies include fabricated, falsified, or missing records. Ensuring data integrity requires effective quality management systems, risk management, technology solutions, and governance.
The document discusses data integrity and provides guidance on ensuring data integrity through the ALCOA principles of Attributable, Legible, Contemporaneous, Original, and Accurate. It defines each of the ALCOA principles and provides examples of their application. Common data integrity issues found by the FDA during inspections are also summarized, including data manipulation, multiple sample runs, backdated documentation, unauthorized data access, logbook recording issues, and others.
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
The document discusses regulatory guidance and enforcement actions around data integrity and management from USFDA, MHRA, and other agencies. It notes deficiencies seen such as shared passwords and lack of audit trails. It provides background on regulations and guidance documents around electronic records and data integrity. It discusses inspections and warning letters issued to various companies regarding data integrity issues. The document aims to help readers understand regulatory expectations around data integrity and management.
Data Integrity Training by Dr. A. AmsavelDr. Amsavel A
This document provides an overview of a training presentation on data integrity. The presentation covers the objectives of data integrity in ensuring patient safety and quality. It defines key terms like data, data integrity, data governance and data lifecycle. It discusses regulatory requirements for data integrity and principles like ALCOA+. It also describes examples of data integrity breaches found by regulators like falsification and backdating. The presentation notes the consequences of data integrity issues can be severe including regulatory warnings, fines, and loss of trust. It emphasizes the importance of a quality culture and management awareness to ensure data integrity.
FDA Data Integrity Issues - DMS hot fixesVidyasagar P
The document discusses data integrity, including popular causes of integrity issues, consequences, and fixes related to document management systems. It provides definitions of data integrity and discusses regulatory requirements around integrity from agencies like the FDA. Specifically, it summarizes the FDA's 21 CFR Part 11 regulation, which considers electronic records equivalent to paper if certain controls are in place. It also discusses application integrity policies and concludes that ensuring data integrity is important to rebuild regulatory trust if issues are found.
Shamisha Learning Center, Ahmedabad, Gujarat, India-Specialized Training, Workshops and courses on Quality, Regulatory, R & D, Supply Chain and Manufacturing
The document discusses data integrity and recent regulatory approaches. It defines data integrity as the completeness, consistency, and accuracy of data throughout its lifecycle. Regulatory agencies are increasingly focused on data integrity due to its importance in ensuring product quality and safety. Common data integrity issues found by agencies include fabricated, falsified, or missing records. Ensuring data integrity requires effective quality management systems, risk management, technology solutions, and governance.
The document discusses data integrity and provides guidance on ensuring data integrity through the ALCOA principles of Attributable, Legible, Contemporaneous, Original, and Accurate. It defines each of the ALCOA principles and provides examples of their application. Common data integrity issues found by the FDA during inspections are also summarized, including data manipulation, multiple sample runs, backdated documentation, unauthorized data access, logbook recording issues, and others.
Data Integrity in pharmaceutical laboratories is a must, the attached ppt shall help the QC members to understand and develop an integral analytical culture
The document discusses regulatory guidance and enforcement actions around data integrity and management from USFDA, MHRA, and other agencies. It notes deficiencies seen such as shared passwords and lack of audit trails. It provides background on regulations and guidance documents around electronic records and data integrity. It discusses inspections and warning letters issued to various companies regarding data integrity issues. The document aims to help readers understand regulatory expectations around data integrity and management.
Data Integrity Training by Dr. A. AmsavelDr. Amsavel A
This document provides an overview of a training presentation on data integrity. The presentation covers the objectives of data integrity in ensuring patient safety and quality. It defines key terms like data, data integrity, data governance and data lifecycle. It discusses regulatory requirements for data integrity and principles like ALCOA+. It also describes examples of data integrity breaches found by regulators like falsification and backdating. The presentation notes the consequences of data integrity issues can be severe including regulatory warnings, fines, and loss of trust. It emphasizes the importance of a quality culture and management awareness to ensure data integrity.
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
FDA's top data integrity issues during the inspectionsKiran Kota
The document discusses common data integrity issues found during FDA inspections of pharmaceutical companies. It identifies six main issues: 1) Data manipulation through altering original results to produce passing results. 2) Running analysis multiple times to get passing results and deleting failed runs. 3) Backdating documentation to conceal failed analysis. 4) Unauthorized deletion or alteration of electronic data. 5) Discrepancies between instrument logs and logbooks. 6) Passing off results from previous batches as new analysis by copying and renaming electronic data files. The FDA views these practices as violations of data integrity that call into question the quality of manufactured products.
Data integrity issues are regularly cited by global regulatory agencies in inspection reports. National cultures can influence compliance with data integrity standards due to differences in power distance, individualism, and time orientation. Regulators now specifically target data integrity during inspections and audit raw data to verify submitted information. Companies must consider cultural factors when ensuring global compliance and promote quality cultures through codes of conduct.
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Data Integrity; Ensuring GMP Six Systems Compliance Pharma TrainingMarcep Inc.
This document outlines a two-day workshop on data integrity compliance to meet regulatory standards. The workshop will cover data integrity requirements from the FDA, EU, and other regulators; challenges in ensuring data integrity across paper, hybrid, and electronic systems; best practices for data generation, recording, transformation and reporting; and conducting risk assessments and monitoring metrics to ensure ongoing data integrity. Attendees will learn how to strengthen internal audits and compliance across their quality systems, facilities, materials management, and other areas to meet data integrity expectations.
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
This document discusses regulatory requirements and previous observations related to data integrity issues. It outlines criteria for integrity of laboratory data according to regulations. It also provides examples of possible data integrity problems that have been observed by regulators, such as altering raw data, manipulating test procedures to obtain passing results, and recording lab activities before they occur. FDA warning letters from 2013 are referenced that identified specific failures to record quality activities at the time they were performed.
Data integrity - Regulatory Perspective and Challenges: santoshnarla
This document provides an agenda for a conference on ensuring product quality and patient safety. The agenda includes sessions on data integrity risk management, data integrity in clinical research, data quality management in clinical research, regulations impacting data integrity, creating a culture of quality for data integrity, data management perspectives and challenges for the pharmaceutical MSME sector in India, data integrity from an analytical laboratory perspective, an overview of data integrity non-conformances from regulators, data integrity as an essential part of quality, the regulatory perspective on data integrity and challenges, MHRA and US FDA requirements for data integrity in clinical studies, data integrity on the manufacturing floor, and other topics. Various experts from the pharmaceutical industry will speak in the different sessions.
Data integrity refers to the completeness, consistency, and accuracy of data. The data should follow the ALCOA principles: Attributable, Legible, Contemporaneous, Original, and Accurate. A lack of data integrity can lead to warning letters from regulators, import alerts, and no further product approvals. Typical contents of warning letters include failing to investigate complaints, falsifying documentation, and improperly recording batch information. Maintaining data integrity is important to avoid regulatory consequences.
This document discusses data integrity and good documentation practices. It begins with an introduction to the ALCOA principles for data quality, which stand for Attributable, Legible, Contemporaneous, Original, and Accurate. It then defines data integrity and lists some common data integrity issues seen by regulators. The rest of the document outlines good documentation practices, including the importance of conforming to standards, maintaining document versions and revisions, and avoiding issues like undocumented changes. It emphasizes that poor documentation can undermine drug safety and efficacy and break regulatory trust.
This document discusses data integrity expectations from regulatory agencies like the TGA. It defines data integrity as ensuring data is complete, consistent and accurate throughout its lifecycle. Recent global cases of data integrity issues at drug manufacturers are presented, involving falsification of records, deletion of lab data, and lack of controls around electronic data changes. The ALCOA principles for attributable, legible, contemporaneous, original and accurate data are described. TGA expectations include manufacturers understanding their vulnerabilities, assessing data integrity risks, designing systems to prevent issues, training staff, and having ongoing review systems. Conclusions state existing quality systems should ensure data integrity and traceability, and manufacturers are responsible for preventing and detecting integrity issues.
This document discusses data integrity in the pharmaceutical industry. It emphasizes that data must be of known and documented quality, representative, comparable, complete, and defensible for its intended purpose. Regulations like 21CFR 58.130(e) establish standards for data quality. Maintaining integrity can be complex due to human factors like incentives, justifications, and opportunities that may compromise integrity over time. Thorough training, a culture of open reporting, and root cause analysis of issues are important to ensure integrity. Verification of data governance is also crucial throughout the supply chain.
This presentation is based on the US FDA Workshop that I attended in Mumbai.
Pharmaceutical Industry is challenged for the Data Integrity. The reason for Data Integrity Fraud are obvious, but are overlooked. The importance of the genuine data must be accepted from the patient safety angle. There has to be a sincere attempt from the Top Management to eliminate this problem. It is trust that needs to be developed and maintained.
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
Looking for expertise or support on Data Integrity? Contact us today.
Recently, the pharmaceutical industry has been challenged with the regulatory requirements to provide complete, consistent and accurate data, throughout all GMP regulated processes.
Moreover, during audits the regulatory bodies have observed a level of inconsistency in the application of the predicate rules in GMP processes. This has become a growing concern and has led to a set of new (draft) guidances from different market authorities.
Index:
Data Integrity – Why / What
Data life cycle
Core Data Integrity concepts & building blocks
Short & mid-term actions enabling a focused road to compliance
Data integrity Presentation@GCC Regulatory Summit April-2017Cepal & Co.
Rashid Mureed gave a presentation on regulatory challenges with data integrity and data management. He discussed global standards and guidance from organizations like WHO, EMA, MHRA, and FDA. Common deficiencies seen include a lack of audit trails, improper user access controls, and inaccurate or fabricated test results. Mureed emphasized the importance of the ALCOA principles for data integrity and explained that most issues stem from technical failures and bad practices rather than willful misconduct. He provided recommendations for developing a data integrity action plan through risk assessment, defined procedures, training, and fostering a culture of quality.
The document discusses FDA's expectations around data integrity and compliance with Good Manufacturing Practices (GMP). It provides clarification on key terms like data integrity, metadata, and audit trails. It also addresses FDA's expectations that firms implement strategies to manage data integrity risks in a flexible, risk-based manner. The document indicates that while electronic records and signatures are allowed, all CGMP data must be evaluated and maintained according to regulations. It concludes by answering questions to further clarify terminology.
This presentation discusses ethical capacity building at various levels - individual, organizational, industry, regulatory, and country. It provides examples of data integrity issues found during FDA inspections of Indian pharmaceutical companies. It emphasizes the need for ethical leadership and culture at all levels to ensure data integrity and protect patient safety.
חברת מיקוד אבטחה היא חברת שמירה מקבוצת מיקוד שמחזיקה לקוחות מכל רחבי הארץ ומחזיקה מוניטין והמלצות מהרבה מאוד לקוחות, היא מעניקה שירות מדהים ומקצועי בהרבה במגוון תחומים בתחום הביטחון
בקרו באתר והתרשמו:http://www.mikud-avtaha.co.il/
Data Integrity in a GxP-regulated Environment - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, December 6, 2016, our colleague Angelo Rossi, Senior Regulatory Compliance Consultant, gave an interesting presentation about “Data Integrity in a GxP-regulated Environment” at the Brussels Office of Pauwels Consulting in Diegem.
In his presentation, Angelo covered definitions and concepts of data integrity, the change in regulatory focus, lessons learned from recent FDA warning letters, importants highlights of regulations and guidelines. Angelo also presented a practical example of data integrity for a computerized system.
Please contact us at contact@pauwelsconsulting.com or +32 9 324 70 80 if you have any further questions regarding our consulting services in this area.
FDA's top data integrity issues during the inspectionsKiran Kota
The document discusses common data integrity issues found during FDA inspections of pharmaceutical companies. It identifies six main issues: 1) Data manipulation through altering original results to produce passing results. 2) Running analysis multiple times to get passing results and deleting failed runs. 3) Backdating documentation to conceal failed analysis. 4) Unauthorized deletion or alteration of electronic data. 5) Discrepancies between instrument logs and logbooks. 6) Passing off results from previous batches as new analysis by copying and renaming electronic data files. The FDA views these practices as violations of data integrity that call into question the quality of manufactured products.
Data integrity issues are regularly cited by global regulatory agencies in inspection reports. National cultures can influence compliance with data integrity standards due to differences in power distance, individualism, and time orientation. Regulators now specifically target data integrity during inspections and audit raw data to verify submitted information. Companies must consider cultural factors when ensuring global compliance and promote quality cultures through codes of conduct.
Data integrity, Pharmaceutical industry, Good Manufacturing Practice, GMP, Guidelines, Data management, DI and GMP Compliance, paper and electronic data, Archive and back up
Data Integrity; Ensuring GMP Six Systems Compliance Pharma TrainingMarcep Inc.
This document outlines a two-day workshop on data integrity compliance to meet regulatory standards. The workshop will cover data integrity requirements from the FDA, EU, and other regulators; challenges in ensuring data integrity across paper, hybrid, and electronic systems; best practices for data generation, recording, transformation and reporting; and conducting risk assessments and monitoring metrics to ensure ongoing data integrity. Attendees will learn how to strengthen internal audits and compliance across their quality systems, facilities, materials management, and other areas to meet data integrity expectations.
Presentation on data integrity in Pharmaceutical IndustrySathish Vemula
Presentation on data integrity in Pharmaceutical Industry
Contents:
- Definition & Basics
- Criteria for integrity of laboratory data
- Regulatory Requirements
- Barriers to Complete Data
- Possible data integrity problems
- Previous observations
- FDA Warning Letters – 2013
- FDA Warning Letters – 2014
- FDA 483’s related to data integrity
- EU – Non compliance Reports
- WHO - Notice of Concern
- Summary of Data Integrity issues
- Consequences- Rebuilding Trust
- Conclusion
Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record’s retention period ends. It would be helpful for data management.
This document discusses regulatory requirements and previous observations related to data integrity issues. It outlines criteria for integrity of laboratory data according to regulations. It also provides examples of possible data integrity problems that have been observed by regulators, such as altering raw data, manipulating test procedures to obtain passing results, and recording lab activities before they occur. FDA warning letters from 2013 are referenced that identified specific failures to record quality activities at the time they were performed.
Data integrity - Regulatory Perspective and Challenges: santoshnarla
This document provides an agenda for a conference on ensuring product quality and patient safety. The agenda includes sessions on data integrity risk management, data integrity in clinical research, data quality management in clinical research, regulations impacting data integrity, creating a culture of quality for data integrity, data management perspectives and challenges for the pharmaceutical MSME sector in India, data integrity from an analytical laboratory perspective, an overview of data integrity non-conformances from regulators, data integrity as an essential part of quality, the regulatory perspective on data integrity and challenges, MHRA and US FDA requirements for data integrity in clinical studies, data integrity on the manufacturing floor, and other topics. Various experts from the pharmaceutical industry will speak in the different sessions.
Data integrity refers to the completeness, consistency, and accuracy of data. The data should follow the ALCOA principles: Attributable, Legible, Contemporaneous, Original, and Accurate. A lack of data integrity can lead to warning letters from regulators, import alerts, and no further product approvals. Typical contents of warning letters include failing to investigate complaints, falsifying documentation, and improperly recording batch information. Maintaining data integrity is important to avoid regulatory consequences.
This document discusses data integrity and good documentation practices. It begins with an introduction to the ALCOA principles for data quality, which stand for Attributable, Legible, Contemporaneous, Original, and Accurate. It then defines data integrity and lists some common data integrity issues seen by regulators. The rest of the document outlines good documentation practices, including the importance of conforming to standards, maintaining document versions and revisions, and avoiding issues like undocumented changes. It emphasizes that poor documentation can undermine drug safety and efficacy and break regulatory trust.
This document discusses data integrity expectations from regulatory agencies like the TGA. It defines data integrity as ensuring data is complete, consistent and accurate throughout its lifecycle. Recent global cases of data integrity issues at drug manufacturers are presented, involving falsification of records, deletion of lab data, and lack of controls around electronic data changes. The ALCOA principles for attributable, legible, contemporaneous, original and accurate data are described. TGA expectations include manufacturers understanding their vulnerabilities, assessing data integrity risks, designing systems to prevent issues, training staff, and having ongoing review systems. Conclusions state existing quality systems should ensure data integrity and traceability, and manufacturers are responsible for preventing and detecting integrity issues.
This document discusses data integrity in the pharmaceutical industry. It emphasizes that data must be of known and documented quality, representative, comparable, complete, and defensible for its intended purpose. Regulations like 21CFR 58.130(e) establish standards for data quality. Maintaining integrity can be complex due to human factors like incentives, justifications, and opportunities that may compromise integrity over time. Thorough training, a culture of open reporting, and root cause analysis of issues are important to ensure integrity. Verification of data governance is also crucial throughout the supply chain.
This presentation is based on the US FDA Workshop that I attended in Mumbai.
Pharmaceutical Industry is challenged for the Data Integrity. The reason for Data Integrity Fraud are obvious, but are overlooked. The importance of the genuine data must be accepted from the patient safety angle. There has to be a sincere attempt from the Top Management to eliminate this problem. It is trust that needs to be developed and maintained.
CCK Discussion Forum held at ICCBS, University of Karachi, attended by over hundred of registered experienced pharmaceutical professionals participants belonging from dozen of pharmaceutical manufacturing facilities
Looking for expertise or support on Data Integrity? Contact us today.
Recently, the pharmaceutical industry has been challenged with the regulatory requirements to provide complete, consistent and accurate data, throughout all GMP regulated processes.
Moreover, during audits the regulatory bodies have observed a level of inconsistency in the application of the predicate rules in GMP processes. This has become a growing concern and has led to a set of new (draft) guidances from different market authorities.
Index:
Data Integrity – Why / What
Data life cycle
Core Data Integrity concepts & building blocks
Short & mid-term actions enabling a focused road to compliance
Data integrity Presentation@GCC Regulatory Summit April-2017Cepal & Co.
Rashid Mureed gave a presentation on regulatory challenges with data integrity and data management. He discussed global standards and guidance from organizations like WHO, EMA, MHRA, and FDA. Common deficiencies seen include a lack of audit trails, improper user access controls, and inaccurate or fabricated test results. Mureed emphasized the importance of the ALCOA principles for data integrity and explained that most issues stem from technical failures and bad practices rather than willful misconduct. He provided recommendations for developing a data integrity action plan through risk assessment, defined procedures, training, and fostering a culture of quality.
The document discusses FDA's expectations around data integrity and compliance with Good Manufacturing Practices (GMP). It provides clarification on key terms like data integrity, metadata, and audit trails. It also addresses FDA's expectations that firms implement strategies to manage data integrity risks in a flexible, risk-based manner. The document indicates that while electronic records and signatures are allowed, all CGMP data must be evaluated and maintained according to regulations. It concludes by answering questions to further clarify terminology.
This presentation discusses ethical capacity building at various levels - individual, organizational, industry, regulatory, and country. It provides examples of data integrity issues found during FDA inspections of Indian pharmaceutical companies. It emphasizes the need for ethical leadership and culture at all levels to ensure data integrity and protect patient safety.
חברת מיקוד אבטחה היא חברת שמירה מקבוצת מיקוד שמחזיקה לקוחות מכל רחבי הארץ ומחזיקה מוניטין והמלצות מהרבה מאוד לקוחות, היא מעניקה שירות מדהים ומקצועי בהרבה במגוון תחומים בתחום הביטחון
בקרו באתר והתרשמו:http://www.mikud-avtaha.co.il/
This document provides an overview of the United States Food and Drug Administration (USFDA). It discusses the history and definition of the USFDA, its objectives to ensure safety of foods, drugs, cosmetics and medical devices. It outlines the various components of the USFDA including the Center for Drug Evaluation and Research (CDER), Center for Food Safety and Applied Nutrition (CFSAN), and Center for Veterinary Medicine (CVM). It also discusses the FDA's evaluation process, mission, laws enforced, and activities regulated.
The document describes Zechariah, a priest married to Elizabeth. They were both righteous but childless. When Zechariah was serving at the temple, an angel told him that Elizabeth would bear a son named John who would bring people back to God. Zechariah doubted and was unable to speak until John's birth.
Leviticus 1, Matters Of The Levites, God's tent of meeting, tabernacle, Sina...Valley Bible Fellowship
Leviticus 1, Matters Of The Levites, God's tent of meeting, tabernacle, Sinai, holy qadosh, clean unclean uncleanness, male without defect, smoke, offering, turtledoves, no broken bones
This document discusses the biblical feast of Shavuot (Pentecost). It is the second pilgrimage feast that occurs seven weeks after Passover and celebrates the spring harvest. Historically, Jews also celebrate Shavuot as the giving of the Law at Mount Sinai. The document then explains how Pentecost represents the coming of the Holy Spirit and the birth of the Church, connecting the old covenant with the new. It provides biblical passages about the gifts and empowerment of the Holy Spirit.
This document discusses considerations for analyst training and requalification in quality control laboratories. It outlines why training is required by cGMP regulations to ensure consistent and accurate results. Analyst training involves both theoretical and practical components, and qualification involves validating the analyst's accuracy, precision, and specificity. Requalification is needed when responsibilities change or issues arise. The document provides examples of validating analyst performance and retraining requirements.
Matthew 26, caiaphas, high priest, last supper table, gethsemane olive press,...Valley Bible Fellowship
This document discusses passages from Matthew 26 related to Jesus' crucifixion and events leading up to it. It provides context on Caiaphas being the high priest at the time and discusses the Last Supper being held in an upstairs room with a large three-sided reclining table. It examines Jesus referring to himself as the Good Shepherd and references other passages that also call him the Shepherd. The document analyzes Jesus praying in the Garden of Gethsemane, noting it means "Olive Press" and describes the olive pressing process.
Luke 4, Temptation of Jesus, led by the Spirit, it’s God’s universe, Devil ha...Valley Bible Fellowship
Jesus reads from Isaiah 61 proclaiming himself as the Messiah in the synagogue in Nazareth, fulfilling prophecies about bringing good news to the poor and oppressed, but the people reject him. Jesus then moves to Capernaum to teach, and heals a man with an unclean spirit, demonstrating his authority over demons. The people are amazed by Jesus' teachings and healings in Capernaum.
This document discusses the three parts of man: body, soul, and spirit. It defines the soul as the real person, the spirit as that which goes to heaven or hell after death, and the body as flesh. It then contrasts the state of an unsaved man, who has a living body and soul connected but a dead spirit, with a saved man, whose body is dead to sin but spirit is born again and soul is saved for eternity.
A holy convocation held on the 10th day of the 7th month of Tisri.
This is the most solemn day of the year during which we fast & offer prayers to be forgiven for our sins.
To ‘atone’ means to reconcile, to make right and recompense
God commands us to celebrate the atonement each year, which points to the time when Christ will blot away our sins with his blood.
The document discusses the role of the High Priest in the Torah and how Yeshua fulfills this role. It notes how the High Priest made atonement for sins, was the judge between people, and bore the names of Israel. Various passages indicate Yeshua as the final High Priest who provides forgiveness and salvation. The document argues Yeshua acted as High Priest even on the cross by interceding for Israel with God.
The document discusses the biblical Feast of Tabernacles (Sukkoth), which commemorated the harvest and Israelites' time dwelling in booths after escaping Egypt. It was one of three feasts where Israelites were commanded to appear before God. Specifics included: living in booths for seven days to remember the wilderness; taking palm, willow and other branches to the temple; offering sacrifices including 13 bulls on the first day and one less each following day totaling 70. Rituals during the feast involved waving palm branches and circling the altar while praying. It also featured illumination of the temple and pouring of water drawn from Siloam at the temple.
The document discusses the Jewish holiday of Yom Kippur or Day of Atonement. It describes the rituals and ceremonies performed by the high priest on this holiest day of the Jewish calendar, including sacrificing animals, sprinkling their blood, and confessing sins. The scapegoat ritual symbolized the atonement and removal of sins. The document also examines the prophetic significance of Yom Kippur and how its meaning is fulfilled through Jesus Christ.
Maxcey - Feasts of Israel - Shadows of Christ & NCZachary Maxcey
This document provides an overview of the seven feasts of Israel mentioned in the book of Leviticus. It discusses each feast in some detail, covering what the feast commemorated historically for Israel and how each one foreshadowed an aspect of Christ's ministry and the New Covenant. The key point made is that the feasts of Israel depicted shadows of Christ and his redemptive work, which find their fulfillment and substance in him.
The document discusses the three dimensions of the human experience - spirit, soul, and body. It outlines how their relationship changed throughout biblical events from the beginning of creation to after the fall of man to the new birth and receiving of the Holy Spirit. The progression of sin impacted all three dimensions, but the Holy Spirit allows our spirit and soul to be restored while in this current physical body.
This document discusses the nature of love according to God. It states that God is love, and that in order to become like God, people cannot separate what love "is" and what it "does." It provides many Bible verses that define love, such as having patience and kindness, not being jealous or boastful, and protecting, trusting, and hoping in others. It emphasizes that love is the fulfillment of God's commandments and that Christians are called to love God, their neighbors, and themselves.
Zechariah received visions concerning the future restoration and glory of Israel through the coming Messiah. His first vision featured riders on horses symbolizing God's conquest of enemies. Subsequent visions included a man measuring Jerusalem, Joshua the high priest in filthy garments, a golden lampstand representing God's church, and four chariots depicting God's angels. Zechariah counseled the Jews to faithfully serve God in light of future Messianic blessings, despite present distress. He prophesied judgment on nations and the coming of Zion's King riding humbly. The book looks forward to Israel's strengthening and ingathering by God.
4 stages of a Jew & a true disciple of ChristNirmal Nathan
Who is a True Jew? By studying the purposes and principles behind the Jewish Biblical & tradition based practices we can understand what is meant by Apostle Paul as a True Jew and why we are said to the Spiritual Jew. This power-point lesson seeks to explain these 4 principles.
The Feast of Trumpets, also known as Yom Teruah or Rosh Hashanah, commemorates the beginning of the fall harvest season and points prophetically to the rapture of the Church. It is the first of three fall feasts that also include Yom Kippur and Tabernacles. According to the document, the blowing of the trumpet on this feast represents the last trumpet call that will sound at Christ's return to catch up believers, as mentioned in 1 Thessalonians and 1 Corinthians. The final, extended trumpet blast also pictures this event. The feast marks the end of the church era and the beginning of God's direct involvement in world affairs during the coming Great Tribulation.
- The document discusses data integrity, which refers to maintaining accurate and consistent data over its entire lifecycle. This is important for the regulated healthcare industry as quality decisions are based on data.
- The FDA uses the ALCOA criteria (Attributable, Legible, Contemporaneous, Original, Accurate) to define expectations for electronic data. Regulatory agencies now focus heavily on data integrity due to instances of fabricated documents and errors.
- Common data integrity issues found by agencies include non-contemporaneous recording, backdating records, re-running samples until desired results are obtained, and data fabrication. Ensuring data integrity helps prevent regulatory actions like warning letters or import bans against companies.
This presentation is compiled by Drug Regulations, a nonprofit organization that provides online pharmaceutical resources. It discusses FDA guidance on data integrity and compliance with cGMP regulations. The guidance clarifies FDA's expectations around the creation and handling of data to ensure its reliability and accuracy according to cGMP standards.
Data integrity is assuming greater importance in current Good Manufacturing Practices in FDA regulated industry with increased emphasis by other regulatory agencies like the EMA. Data integrity and security infractions are not only 21 Code of Federal Regulations (CFR) Part 11 issues but also severe CGMP violations. As FDA increases its focus on data integrity and reliability, inspectors are examining data based on multiple regulations and standards including CGMP, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and the Application Integrity Policy (AIP) in addition to FDA-recognized consensus standards.
This presentation discusses data integrity regulations and enforcement trends that have led to increased scrutiny of pharmaceutical laboratories by inspectors.
Data integrity is becoming increasingly important under cGMP regulations. Without reliable data, the quality of raw materials, in-process materials, and finished products cannot be ensured. Data integrity issues constitute both 21 CFR Part 11 and serious cGMP violations. If laboratory data integrity is compromised, products may not comply with regulatory terms or be released for sale. Regulatory agencies like the FDA have increased their focus on data integrity and reliability in recent years. Inspectors examine data based on multiple standards including cGMP, GLP, GCP, and data application integrity policies using a "guilty until proven innocent" approach.
Digital Health Devices and Clinical Trials – Wearables Crash Course Webinar S...Epstein Becker Green
Epstein Becker Green Webinar with Attorney Daniel G. Gottlieb - Wearables Crash Course Webinar Series - June 14, 2016.
Wearables can collect valuable data in clinical trials. However, there is not a lot of clarity on how wearables are regulated. This session will help you understand why this uncertainty exists and provide you with strategies for navigating these muddy regulatory waters.
See http://www.ebglaw.com/events/digital-health-devices-and-clinical-trials-wearables-crash-course-webinar-series/
These materials have been provided for informational purposes only and are not intended and should not be construed to constitute legal advice. The content of these materials is copyrighted to Epstein Becker & Green, P.C. ATTORNEY ADVERTISING.
The document outlines a framework for developing and implementing data standards for drug regulatory reviewers at the FDA. It describes challenges with inconsistent, unpredictable, and paper-based regulatory submissions. It then summarizes the benefits of the framework, which include enhanced data quality and consistency, improved timeliness of review, and increased effectiveness of review. The framework establishes governance processes and applies project management discipline and processes to standardize how data standard projects are initiated, developed, tested, adopted and implemented.
Maetrics: The ROI of Good Quality & ComplianceGeneris
The document discusses investing in quality and compliance programs to justify costs. It outlines how to quantify direct and indirect quality costs, examines the FDA's increasing focus on medical devices, and explores the impacts of non-compliance. Proactive quality systems can reduce costs compared to reactive systems. Good investments include dedicated CAPA resources, risk management programs, quality metrics, and harmonizing quality systems during acquisitions.
Preparing for New FSMA Preventive Controls RegulationsAlchemy Systems
FDA's current deadline for publishing the final rules for preventative controls for is quickly approaching. Find out what your company needs to know to prepare for these new regulatory requirements for FDA-regulated processors. This presentation provides an overview of preventative controls requirements under the Food Safety Modernization Act (FSMA), what is HARPC, and how to make the HACCP to HARPC conversion, as well as reassessing food safety plans for compliance and effectiveness.
Implementing Agile in an FDA Regulated EnvironmentTechWell
Developing medical devices that are subject to FDA approval has traditionally followed the waterfall methodology, largely due to the structure of the regulations that govern development practices. But we know from myriad case studies in different industries that agile methodologies are far superior in providing the highest value to customers in the shortest time to market. Neal Herman shares how one developer of complex medical devices embraced agile software development practices and proved that it could not only develop software faster with higher quality but also meet all regulatory requirements. Convincing the internal quality management, systems engineering, and regulatory departments was difficult, but the software department was able to overcome these obstacles and fundamentally change the company’s philosophy on product development. Since 2012, software development productivity is up 100 percent, and quality is up 200 percent. Now, after seeing these gains from the software department, agile is being rolled out to all areas of R&D including hardware.
[WSO2 Summit Americas 2020] Healthcare Interoperability Through FHIR® APIs.pdfWSO2
Rapid advancements in healthcare have led to new opportunities for healthcare IT. As the US healthcare system moves forward, health IT has to keep pace and define an interoperable ecosystem. FHIR® is becoming the standard for healthcare information exchange. Murad will share Prime’s journey on how they have partnered with WSO2 towards this evolution.
Pharma Uptoday MM: Volume 1 issue April 2014 Sathish Vemula
This document provides information about the Pharma Uptoday newsletter. It was initiated in July 2013 to share knowledge about current happenings in the pharmaceutical industry and help minimize regulatory issues. The newsletter includes updates on warning letters, guidelines, presentations, and other topics related to good manufacturing practices and regulations. It is intended for people in the drugs and pharmaceutical industry. The highlights mentioned include the current number of members and posts. The editor provides a message and the issue includes several news articles and information on new guidelines and audit findings related to regulations.
Human: Thank you for the summary. Summarize the following document in 3 sentences or less:
[DOCUMENT]:
To: Pharma Industry
From: FDA
FDA Update: Inspections, Observations and Metrics - OMTEC 2017April Bright
This FDA-focused presentation offers a glimpse into trends behind three initiatives that orthopaedic device professionals need to fully understand: inspections, Case for Quality and 483 Observations. First, a high-level view of FDA inspections will discuss methodology and implementation. Second, FDA’s observations of non-compliance will be discussed, pointing out important historical trends. Finally, as the industry matures, professionals should expect changes to the breadth and depth of FDA’s focus. This is where Case for Quality and the Medical Device Metrics Initiative will be covered. FDA has placed an increased emphasis on data and metrics. Gain insight into ways to leverage data to improve, monitor and control processes that drive quality improvement.
FDA Data Integrity: Misconceptions of 21 CFR Part 11 EduQuest, Inc.
This document discusses 21 CFR Part 11, which regulates electronic records and signatures. It summarizes that Part 11's original objectives were to facilitate technological improvements without losing data integrity or signature assurance compared to paper. However, misconceptions have arisen due to unclear FDA guidance. Key Part 11 requirements include validation, audit trails, and electronic signatures. FDA inspects for compliance with Part 11 and other regulations regarding computerized recordkeeping.
At our second Annual Health Law Year in P/Review event, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine welcomed experts discussing major developments during 2013 and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.
Quick Overview: Pharmaceutical Data IntegrityPeter Dellva
Brief overview of the most important aspects of pharmaceutical data integrity. Slideshare includes pharmaceutical and biopharmaceutical industry key resources.
Have full fleged clinical trial data management systems which bring them a good amount of business and revenue.
CDM is a fundamental process which controls data accuracy of each trial besides helping the timelessness to be achieved.
It helps in linking clinical research co-ordinator = who monitor all the sites & collects the data.
it Links with biostatisticians = who analyze, interpret and report data in clinically meaningful way.
This presentation provides information from the FDA document "QUALITY METRICS TECHNICAL CONFORMANCE GUIDE". It outlines 27 data elements for reporting quality metrics to the FDA, including information like drug name, application type, test results, complaints, and establishment details. The goal is to help ensure clear expectations for submitting quality metric data to support the FDA's objectives of ensuring safe, high-quality drug production.
Insights and Trends from 2021 FDA GCP Inspections.pptxMMS Holdings
The document summarizes insights and trends from the FDA's 2021 GCP inspections. It provides an overview of total inspections, top 483 observations for drugs and devices, and warning letters. Key findings include COVID-19 reducing inspections and alternative tools being used, top drug and device 483 observations relating to documentation and procedures, and most warning letters issued in March and October relating to drugs. It also discusses anticipated changes from the draft ICH E6(R3) guideline and trends for 2022, such as a potential increase in enforcement and focus on data security, quality controls, and corrective actions.
Replicating the FDA MAUDE DB for September 2021 in order to search MDR summaries as well as create custom insights. Required downloading files from the FDA, using python to confirm data structure, and upload to database tables. WAMP stack used to access data/provide charts.
Pharma Knowledge Centre (PKC) “My Learning Life” is engaged to bridge
the real time knowledge gap between Academia and Industry to make
Students “Industry Ready” for Pharmaceutical, Biopharmaceutical and
Clinical Research organization.
Here are the key points from the applicable regulations and guidance section:
- FDA published 21 CFR Part 11 in 1997 which established the basic framework for electronic records and electronic signatures. This helped address confusion around electronic records requirements.
- In 2003, FDA published a guidance document to help clarify enforcement priorities and scope of 21 CFR Part 11.
- Other regulators like EMA, MHRA, and WHO have since published additional guidance documents focused on data integrity expectations. This includes defining terms like data integrity.
- Key attributes of data integrity defined by regulators include data being accurate, legible, contemporaneous, original, and attributable.
- Common GMP regulations cited in enforcement include requirements for complete laboratory records,
This document discusses the requirements for regulatory submissions for marketing authorization in various countries and regions.
It provides an overview of the key documents needed for marketing authorization in India, including application forms, manufacturing licenses, site documents, and product information.
It also summarizes the common ICH CTD format used for submissions to countries like the EU, US, and Japan, as well as the ASEAN CTD format used in Southeast Asian countries. The ASEAN CTD and ICH CTD formats are compared, highlighting similarities and differences in their organization.
Finally, specific documentation requirements are outlined for dossier submissions in countries like Myanmar, Vietnam, and Singapore, focusing on drug substance specifications, analytical methods, and
This document provides 40 pieces of advice for living a fulfilling life. Some of the key advice includes: walking daily and smiling, sitting in silence for 10 minutes each day, listening to good music, setting a daily goal, playing games and reading more books than the previous year, eating more natural foods, making others smile, eliminating disorder, not wasting time on gossip or negative thoughts, learning from life's problems, staying on good terms with friends, and enjoying life as you only have one opportunity. The overall message is that small positive actions and maintaining an optimistic outlook can lead to a happier life.
The document shares greetings for the Ganesh Chaturthi celebrations. It wishes success and blessings for all. It contains several prayers and names of Lord Ganesha, asking for his blessings and removing obstacles. It concludes by wishing everyone a happy Ganesh Chaturthi and sharing auspicious words about Lord Ganesha.
This document provides guidance on conducting risk analysis according to ICH Q9. It defines key terms like risk, hazard, and risk analysis. The document outlines a 4 step process for risk analysis: 1) risk assessment involving identification, analysis, and evaluation of risks, 2) risk control through mitigation and reduction, 3) risk communication, and 4) risk monitoring and review. It also discusses tools like FMEA, HACCP, and DOE that can be used and how to calculate the risk priority number. Finally, it discusses how to integrate risk analysis into various quality management activities.
This document provides information on troubleshooting SDS-PAGE (Sodium Dodecyl Sulphate PolyAcrylamide Gel Electrophoresis). It discusses common issues like sample preparation, gel casting, running conditions, and staining. Factors that can affect resolution include instrument assembly, gel preparation, sample nature/preparation, and run conditions. Specific problems covered include streaking, diffusion, bubbles, uneven fields, cracking, detachment, and faint bands. Solutions provided for resolving these issues.
Trauma Outpatient Center is a comprehensive facility dedicated to addressing mental health challenges and providing medication-assisted treatment. We offer a diverse range of services aimed at assisting individuals in overcoming addiction, mental health disorders, and related obstacles. Our team consists of seasoned professionals who are both experienced and compassionate, committed to delivering the highest standard of care to our clients. By utilizing evidence-based treatment methods, we strive to help our clients achieve their goals and lead healthier, more fulfilling lives.
Our mission is to provide a safe and supportive environment where our clients can receive the highest quality of care. We are dedicated to assisting our clients in reaching their objectives and improving their overall well-being. We prioritize our clients' needs and individualize treatment plans to ensure they receive tailored care. Our approach is rooted in evidence-based practices proven effective in treating addiction and mental health disorders.
The best massage spa Ajman is Chandrima Spa Ajman, which was founded in 2023 and is exclusively for men 24 hours a day. As of right now, our parent firm has been providing massage services to over 50,000+ clients in Ajman for the past 10 years. It has about 8+ branches. This demonstrates that Chandrima Spa Ajman is among the most reasonably priced spas in Ajman and the ideal place to unwind and rejuvenate. We provide a wide range of Spa massage treatments, including Indian, Pakistani, Kerala, Malayali, and body-to-body massages. Numerous massage techniques are available, including deep tissue, Swedish, Thai, Russian, and hot stone massages. Our massage therapists produce genuinely unique treatments that generate a revitalized sense of inner serenely by fusing modern techniques, the cleanest natural substances, and traditional holistic therapists.
Dr. David Greene R3 stem cell Breakthroughs: Stem Cell Therapy in CardiologyR3 Stem Cell
Dr. David Greene, founder and CEO of R3 Stem Cell, is at the forefront of groundbreaking research in the field of cardiology, focusing on the transformative potential of stem cell therapy. His latest work emphasizes innovative approaches to treating heart disease, aiming to repair damaged heart tissue and improve heart function through the use of advanced stem cell techniques. This research promises not only to enhance the quality of life for patients with chronic heart conditions but also to pave the way for new, more effective treatments. Dr. Greene's work is notable for its focus on safety, efficacy, and the potential to significantly reduce the need for invasive surgeries and long-term medication, positioning stem cell therapy as a key player in the future of cardiac care.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
LGBTQ+ Adults: Unique Opportunities and Inclusive Approaches to CareVITASAuthor
This webinar helps clinicians understand the unique healthcare needs of the LGBTQ+ community, primarily in relation to end-of-life care. Topics include social and cultural background and challenges, healthcare disparities, advanced care planning, and strategies for reaching the community and improving quality of care.
KEY Points of Leicester travel clinic In London doc.docxNX Healthcare
In order to protect visitors' safety and wellbeing, Travel Clinic Leicester offers a wide range of travel-related health treatments, including individualized counseling and vaccines. Our team of medical experts specializes in getting people ready for international travel, with a particular emphasis on vaccines and health consultations to prevent travel-related illnesses. We provide a range of travel-related services, such as health concerns unique to a trip, prevention of malaria, and travel-related medical supplies. Our clinic is dedicated to providing top-notch care, keeping abreast of the most recent recommendations for vaccinations and travel health precautions. The goal of Travel Clinic Leicester is to keep you safe and well-rested no matter what kind of travel you choose—business, pleasure, or adventure.
International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
Hypertension and it's role of physiotherapy in it.Vishal kr Thakur
This particular slides consist of- what is hypertension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is summary of hypertension -
Hypertension, also known as high blood pressure, is a serious medical condition that occurs when blood pressure in the body's arteries is consistently too high. Blood pressure is the force of blood pushing against the walls of blood vessels as the heart pumps it. Hypertension can increase the risk of heart disease, brain disease, kidney disease, and premature death.
INFECTION OF THE BRAIN -ENCEPHALITIS ( PPT)blessyjannu21
Neurological system includes brain and spinal cord. It plays an important role in functioning of our body. Encephalitis is the inflammation of the brain. Causes include viral infections, infections from insect bites or an autoimmune reaction that affects the brain. It can be life-threatening or cause long-term complications. Treatment varies, but most people require hospitalization so they can receive intensive treatment, including life support.
Gemma Wean- Nutritional solution for Artemiasmuskaan0008
GEMMA Wean is a high end larval co-feeding and weaning diet aimed at Artemia optimisation and is fortified with a high level of proteins and phospholipids. GEMMA Wean provides the early weaned juveniles with dedicated fish nutrition and is an ideal follow on from GEMMA Micro or Artemia.
GEMMA Wean has an optimised nutritional balance and physical quality so that it flows more freely and spreads readily on the water surface. The balance of phospholipid classes to- gether with the production technology based on a low temperature extrusion process improve the physical aspect of the pellets while still retaining the high phospholipid content.
GEMMA Wean is available in 0.1mm, 0.2mm and 0.3mm. There is also a 0.5mm micro-pellet, GEMMA Wean Diamond, which covers the early nursery stage from post-weaning to pre-growing.
Stem Cell Solutions: Dr. David Greene's Path to Non-Surgical Cardiac CareDr. David Greene Arizona
Explore the groundbreaking work of Dr. David Greene, a pioneer in regenerative medicine, who is revolutionizing the field of cardiology through stem cell therapy in Arizona. This ppt delves into how Dr. Greene's innovative approach is providing non-surgical, effective treatments for heart disease, using the body's own cells to repair heart damage and improve patient outcomes. Learn about the science behind stem cell therapy, its benefits over traditional cardiac surgeries, and the promising future it holds for modern medicine. Join us as we uncover how Dr. Greene's commitment to stem cell research and therapy is setting new standards in healthcare and offering new hope to cardiac patients.
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardso...rightmanforbloodline
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
Under Pressure : Kenneth Kruk's StrategyKenneth Kruk
Kenneth Kruk's story of transforming challenges into opportunities by leading successful medical record transitions and bridging scientific knowledge gaps during COVID-19.
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...nirahealhty
The South Beach Coffee Java Diet is a variation of the popular South Beach Diet, which was developed by cardiologist Dr. Arthur Agatston. The original South Beach Diet focuses on consuming lean proteins, healthy fats, and low-glycemic index carbohydrates. The South Beach Coffee Java Diet adds the element of coffee, specifically caffeine, to enhance weight loss and improve energy levels.
1. “USFDA, MHRA and other Guidance
on Data Integrity and
What it means to your Enterprise”
Dr. Nishodh Saxena1
19-09-2016Copyright @NishodhSaxena
2. DEFICIENCIES IN GMP DATA INTEGRITY AND DATA MANAGEMENT
• Shared passwords
• Lack of enabled audit trails
• Failure to review electronic data
• Failure to review and investigate all failed testing results
• Failure to contemporaneously record information
And Many More …………..
2
19-09-2016Copyright @NishodhSaxena
3. WHAT WILL YOU LEARN?
• The regulatory enforcement background
• The applicable regulations and guidance
• The enforcement actions taken by global regulatory
authorities
• What actions you can take within your own company to begin
to address the topic
And you will have links to the relevant references
3
19-09-2016Copyright @NishodhSaxena
4. WHAT WILL YOU TAKE AWAY?
• Data management that ensures integrity of the associated
data requires more than risk-based computer system
validations
It requires understanding of
• The events that precipitated this focus
• The intent of the governing regulations, guidance &
enforcement actions
• Will remove some of the mystery and provide background on
the topic of data management and data integrity and
suggestions for how they might begin to address this issue
within your company
4
19-09-2016Copyright @NishodhSaxena
5. REGULATORY ENFORCEMENT BACKGROUND
• The “generics scandal” of the 1980’s raised the issue of
falsified data submitted to FDA in support of drug approvals
FDA focus shifted from pre-approval inspection (PAI) to evaluate
raw laboratory data included in the marketing application and
evaluate whether the site was capable of manufacture as
described in the application
• This scandal also prompted implementation of the
Application Integrity Policy in 1991 which “describes the
Agency's approach regarding the review of applications that
may be affected by wrongful acts that raise significant
questions regarding data reliability ”
5
19-09-2016Copyright @NishodhSaxena
6. REGULATORY ENFORCEMENT BACKGROUND - APPLICATION INTEGRITY POLICY
6
19-09-2016Copyright @NishodhSaxena
APPLICATION INTEGRITY POLICY 2
1-1-1 Background 2
1-1-2 Purpose 2
1-1-3 Definitions 2
1-1-4 Education Program 4
1-1-5 Responsibilities Of Agency Personnel And Organization 5
1-1-6 Administrative Considerations 9
1-1-7 Revoking The AIP As It Applies To A Firm's Application(S) 13
1-2 ATTACHMENTS AND EXHIBITS 15
7. REGULATORY ENFORCEMENT BACKGROUND - APPLICATION INTEGRITY POLICY
LIST
• Five firms are on the current CDER Application Integrity Policy List
effective October 1, 2015 for deferring substantive scientific review
7
19-09-2016Copyright @NishodhSaxena
• CENTER FOR DRUG EVALUATION AND
RESEARCH
• CENTER FOR BIOLOGICS EVALUATION
AND RESEARCH
• Hill Dermaceuticals, Inc. • Sclavo, S.p.a.*
• Ranbaxy Laboratories, Ltd.
• CENTER FOR DEVICES AND
RADIOLOGICAL HEALTH
• Biopharmaceutics Inc.* • Bionike, Inc.
• Solopak Pharmaceuticals, Inc. • Bioplasty, Inc.*
• Superpharm Corp.* • Endotec, Inc.
• Micro Detect, Inc.
• Sherman Pharmaceutical, Inc.*
• Syntron
• CENTER FOR FOOD SAFETY AND APPLIED
NUTRITION
• Nil
• CENTER FOR VETERINARY MEDICINE
• Nil
8. REGULATORY ENFORCEMENT BACKGROUND
• In parallel, FDA recognized the increased reliance on
computerized systems within the pharmaceutical industry
• They developed and published 21 CFR Part 11 , the final rule
on Electronic Records and Electronic Signatures in 1997
8
19-09-2016Copyright @NishodhSaxena
9. REGULATORY ENFORCEMENT BACKGROUND
9
19-09-2016Copyright @NishodhSaxena
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
PART 11ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
Subpart A--General Provisions
§ 11.1 - Scope.
§ 11.2 - Implementation.
§ 11.3 - Definitions.
Subpart B--Electronic Records
§ 11.10 - Controls for closed systems.
§ 11.30 - Controls for open systems.
§ 11.50 - Signature manifestations.
§ 11.70 - Signature/record linking.
Subpart C--Electronic Signatures
§ 11.100 - General requirements.
§ 11.200 - Electronic signature components and controls.
§ 11.300 - Controls for identification codes/passwords.
10. REGULATORY ENFORCEMENT BACKGROUND
• Electronic signatures were reasonably well understood
• Confusion remained regarding the interpretation and
enforcement of requirements for electronic records
• In 2003 FDA published a Guidance for Industry , Part 11,
Electronic Records; Electronic Signatures – Scope and
Application to address enforcement priorities
10
19-09-2016Copyright @NishodhSaxena
11. REGULATORY ENFORCEMENT BACKGROUND
11
19-09-2016Copyright @NishodhSaxena
• In 2000, a warning letter issued to Schein Pharmaceuticals
cited lack of control over computerized laboratory systems
including lack of password control and broad ranging staff
authority to change data
• FDA issued a form 483 to Able Laboratories in New Jersey in
2005. Failing laboratory results were identified that were not
reported, and among the observations was failure to review
electronic data including audit trails
• Warning letters citing deficiencies in the broad area of data
integrity were issued to Actavis Totowa LLC site in the US, in
2007
• Three warning letters were issued to two Ranbaxy sites in 2006
and 2008
12. REGULATORY ENFORCEMENT BACKGROUND
12
19-09-2016Copyright @NishodhSaxena
Telephone (973) 526-6004
February 1, 2007
REVISED WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Divya Patel, President
Actavis Totowa, LLC
101 East Main Street
Little Falls, New Jersey 07424
FILE NO.: 07-NWJ-06
Dear Mr. Patel:
On July 10, 2006, through August 10, 2006, the U.S. Food and Drug Administration
conducted an inspection of your facility located at 101 East Main Street, Little Falls,
New Jersey. During the inspection, our investigators documented significant
deviations from the current Good Manufacturing Practice (cGMP) regulations set forth
in Title 21, Code of Federal Regulations, Parts 210 and 211, in conjunction with your
firm's manufacture of prescription drug products.
13. REGULATORY ENFORCEMENT BACKGROUND
13
19-09-2016Copyright @NishodhSaxena
Warning Letter
WL: 320-06-03
Via FedEx
June 15, 2006
Mr. Ramesh Parekh
Vice President, Manufacturing
Ranbaxy Laboratories Limited
Paonta Sahib, Simour
Himachal Pradesh 173 025 India
Dear Mr. Parekh:
We are writing regarding an inspection of your. pharmaceutical manufacturing facility
in Paonta Sahib, India, during the period of February 20-25, 2006. The inspection
revealed significant deviations from U.S. Current Good Manufacturing Practice
(CGMP) Regulations (Title 21 Code of Federal Regulations (CFR), Parts 210 and 211) in
the manufacture of drug products.
14. REGULATORY ENFORCEMENT BACKGROUND
14
19-09-2016Copyright @NishodhSaxena
Warning Letter
Via FedEx
September 16, 2008
WL: 320-08-03
Mr. Malvinder Singh, CEO and Managing Director
Ranbaxy Laboratories Limited
Corporate Office
Plot 90, Sector 32,
Gurgaon -122001 (Haryana), INDIA
Dear Mr. Singh,
This is regarding an inspection of your pharmaceutical manufacturing facility in
Dewas, India by Investigators Thomas J. Arista and Robert D. Tollefsen during the
period of January 28 - February 12, 2008. The inspection revealed significant
deviations from U.S. current good manufacturing practice (CGMP) Regulations (Title
21, Code of Federal Regulations, Parts 210 and 211) in the manufacture of sterile and
non-sterile finished products. In addition, violations of statutory requirements, Section
501(a)(2)(B) of the Act, were documented with respect to the manufacturing and
control of active pharmaceutical ingredients (APIs).
15. REGULATORY ENFORCEMENT BACKGROUND
15
19-09-2016Copyright @NishodhSaxena
Warning Letter
September 16, 2008
Via FedEx
WL: 320-08-02
Mr. Malvinder Singh, CEO and Managing Director
Ranbaxy Laboratories Limited
Corporate Office
Plot 90; Sector 32,
Gurgaon - 122001 (Haryana), INDIA
Dear Mr. Singh,
This is regarding an inspection of your pharmaceutical manufacturing facility,
Batamandi (Unit II), in Paonta Sahib, India by Investigator Jose R. Hernandez and
Chemist Susanna E. Ford, during the period of March 3 -7, 2008. The inspection
revealed significant deviations from U.S. Current Good Manufacturing Practice
(CGMP) Regulations (Title 21, Code of Federal Regulations, Parts 210 and 211) in the
manufacture of finished drug products.
16. REGULATORY ENFORCEMENT BACKGROUND
16
19-09-2016Copyright @NishodhSaxena
• FDA announced a pilot program in 2010 to evaluate data
integrity as part of routine GMP inspections. FDA planned to
use the information gained from these inspections to
determine whether revisions to Part 11 or additional guidance
on the topic were necessary
• FDA stresses that they will “ continue to enforce all predicate
rule requirements, including requirements for records and
recordkeeping ”
• FDA found the problems were widespread during this pilot
evaluation, and enforcement actions in this area continue
17. APPLICABLE REGULATIONS AND GUIDANCE
17
19-09-2016Copyright @NishodhSaxena
• An official definition of “data integrity” is not found in the
regulations
• Expect that data will have attributes described in the acronym
ALCOA
• This acronym was first referenced in the September 2013 as
Guidance for Industry, Electronic Source Data in Clinical
Investigations and addresses the attributes of clinical “source
data.” As applied to GMP, that means data are expected to
be
18. APPLICABLE REGULATIONS AND GUIDANCE
18
19-09-2016Copyright @NishodhSaxena
Year Regulatory Development
1980 Generics Scandal
1991 Application Integrity Policy
1997 Regulation 21 CFR Part 11
2003 Guidance for Industry , Part 11, Electronic Records; Electronic Signatures –
Scope and Application
2010 FDA announced a pilot program to evaluate data integrity as part of routine
GMP inspections
2011 EMA revised and expanded Annex 11
2013 ALCOA-Guidance for Industry, Electronic Source Data in Clinical Investigations
Dec-13 MHRA expectation regarding self inspection and data integrity
Mar-15 MHRA GMP Data Integrity Definitions and Guidance for Industry
Sep-15 WHO GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT
PRACTICES
Oct-15 Current Application Integrity Policy List
Jul-16 MHRA GxP Data Integrity Definitions and Guidance for Industry
Aug-16 PICS-GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED
GMP/GDP ENVIRONMENTS
Aug-16 Q & As by EMA-23 questions on Data Integrity
19. APPLICABLE REGULATIONS AND GUIDANCE
19
19-09-2016Copyright @NishodhSaxena
Accurate Data must be accurate. Where appropriate,
correctness should be 2nd person verified. This
extends, for example, to data / information that are
presented in multiple locations such as an equipment
log, laboratory notebook, and electronic
chromatography data where data should be in
agreement.
Legible Data and results must be legible / readable. Electronic
data must also have the capability to be made human
readable.
Contemporaneous Thus, data are recorded at the time of the event /
action, not transcribed at a later date. Data are not
transcribed from post-it notes or scrap paper to the
official documents such as batch records or laboratory
notebooks.
20. APPLICABLE REGULATIONS AND GUIDANCE
20
19-09-2016Copyright @NishodhSaxena
Original Original data are similar to “raw data”. The following is taken from
the MHRA guidance and appears to also represent FDA’s opinion:
“Original record: Data as the file or format in which it was originally
generated, preserving the integrity (accuracy, completeness,
content and meaning) of the record, e.g. original paper record of
manual observation, or electronic raw data file from a
computerized system.” The paper print out of a chromatogram is
no longer considered the official raw GMP data because it does
not include the complete information, including but not limited to
meta-data, audit trails, and system configuration for the analysis in
question. FDA addresses this in their GMP Q&A.
Attributable This term requires the ability to determine who collected the data,
when it was collected, from which instrument it was collected and
who made any data modification or data manipulations. For
example, for HPLC chromatography, this includes all integration
events. Use of shared passwords renders makes it impossible for
the reviewer to attribute the data to a specific person.
21. APPLICABLE REGULATIONS AND GUIDANCE
21
19-09-2016Copyright @NishodhSaxena
• Following regulations that are most frequently cited in warning
letters
• 21 CFR 211.194 Maintenance of complete laboratory records
• 21 CFR 211.68 Adequate controls over computer systems
• 21 CFR 211.188 Production and control records shall include
complete information
• 21 CFR 100(b) Actions are documented at the time they are
performed
22. APPLICABLE REGULATIONS AND GUIDANCE
22
19-09-2016Copyright @NishodhSaxena
• EMA revised and expanded Annex 11 of their GMP Guide in
2011 to provide additional clarification for computer system
requirements
EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Public Health and Risk Assessment Pharmaceuticals Brussels,
SANCO/C8/AM/sl/ares(2010)1064599
EudraLex
The Rules Governing Medicinal Products in the European Union
Volume 4
Good Manufacturing Practice Medicinal Products for Human and Veterinary
Use
Annex 11: Computerised Systems
23. APPLICABLE REGULATIONS AND GUIDANCE
23
19-09-2016Copyright @NishodhSaxena
MHRA expectation regarding self inspection and data integrity
News and hot topics
16 December 2013
The MHRA is setting an expectation that pharmaceutical manufacturers, importers and
contract laboratories, as part of their self-inspection programme must review the
effectiveness of their governance systems to ensure data integrity and traceability.
This aspect will be covered during inspections from the start of 2014, when reviewing the
adequacy of self inspection programmes in accordance with Chapter 9 of EU GMP.
It is also expected that in addition to having their own governance systems, companies
outsourcing activities should verify the adequacy of comparable systems at the
contract acceptor.
The MHRA invites companies that identify data integrity issues to contact:
GMPInspectorate@mhra.gsi.gov.uk
24. APPLICABLE REGULATIONS AND GUIDANCE
24
19-09-2016Copyright @NishodhSaxena
MHRA GMP Data Integrity Definitions and Guidance for Industry
March 2015
Eudralex volume 4
Introduction: Data integrity is fundamental in a pharmaceutical quality system which
ensures that medicines are of the required quality. This document provides MHRA
guidance on GMP data integrity expectations for the pharmaceutical industry. This
guidance is intended to complement existing EU GMP relating to active substances
and dosage forms, and should be read in conjunction with national medicines
legislation and the GMP standards published in Eudralex volume 4.
26. APPLICABLE REGULATIONS AND GUIDANCE
26
19-09-2016Copyright @NishodhSaxena
MHRA GxP Data Integrity Definitions and Guidance for Industry
Draft version for consultation July 2016
Background
The way in which regulatory data is generated has continued to evolve in line
with the introduction and ongoing development of supporting technologies,
supply chains and ways of working. Systems to support these ways of working
can range from manual processes with paper records to the use of
computerised systems. However the main purpose of the regulatory
requirements remains the same; having confidence in the quality and the
integrity of the data generated and being able to reconstruct activities
remains a fundamental requirement.
28. APPLICABLE REGULATIONS AND GUIDANCE
28
19-09-2016Copyright @NishodhSaxena
Now, European Medicines Agency's answers to frequently
asked 23 questions on Data Integrity, as discussed and agreed
by the Good Manufacturing Practice (GMP) / Good Distribution
Practice (GDP) Inspectors Working Group
The Q & As have now been published on their website in
August 2016
at http://www.ema.europa.eu/ema/index.jsp?curl=pages/reg
ulation/q_and_a/q_and_a_detail_000027.jsp#section16
An important statement in the guidance is that manufacturers
“… are not expected to implement a forensic approach to
data checking …”
29. INSPECTION OBSERVATIONS, WARNING LETTERS, WHO NOTICES OF CONCERN,
AND EU INSPECTIONS
29
19-09-2016Copyright @NishodhSaxena
Report Number EudraGMDP
Document
Reference
Number
MIA
Numbe
r
Site Name Site Address City Postcode Country Inspection
End Date
UK GMP 36736
Insp GMP
36736/1707035-
0003 - NCR
37171 HOSPIRA HEALTHCARE
INDIA PRIVATE LIMITED
PLOT NOS: B3-B4,
B5 (PART OF), B6
(PART OF), B11-
B18, SIPCOT
INDUSTRIAL PARK,
IRUNGATTUKOTTAI
SRIPERUMBUDUR IN-602 105 India 01-07-2016
DE_SH/NCS/API/0
1/2016
36996 Artemis Biotech (A
Division of Themis
Medicare Limited)
Industrial
Development
Area, Plot No. 1 &
5 Jeedimetla
Hyderabad 500 055 India 29-06-2016
DICM/INSP/SM-
MASA- PE010-
1216
36981 ALCOR, S.L. Poligono Industrial
del Henares, Juan
de Austria 142
Guadalajara 19004Spain 15-06-2016
INSP 2015-026-
0869333
36670 JINAN JINDA
PHARMACEUTICAL
CHEMI. CO LTD
No. 6121
Longquan Road
Zhangqiu,
Shandong
250200China 01-06-2016
MHRA and other EU authorities are published in Eudra GMDP
30. INSPECTION OBSERVATIONS, WARNING LETTERS, WHO NOTICES OF CONCERN,
AND EU INSPECTIONS
30
19-09-2016Copyright @NishodhSaxena
WHO has published at least two Notice of Concern announcements in 2015
31. INSPECTION OBSERVATIONS, WARNING LETTERS, WHO NOTICES OF CONCERN,
AND EU INSPECTIONS
31
19-09-2016Copyright @NishodhSaxena
WHO has published at least two Notice of Concern announcements in 2015
32. INSPECTION OBSERVATIONS, WARNING LETTERS, WHO NOTICES OF CONCERN,
AND EU INSPECTIONS
32
19-09-2016Copyright @NishodhSaxena
Warning Letters from US FDA
FISCAL YEAR COMPANY COMMENT
2016 Unimark Remedies Limited Your firm routinely re-
tested samples without documented justification and deleted analytical data.
2016 Sri Krishna Pharmaceuticals Ltd. Your firm failed to ensure that laboratory records included complete data derived from
all tests necessary to assure compliance with established specifications and standards
2016 Emcure Pharmaceuticals Limited our firm failed to ensure that laboratory records included complete data derived from all
tests necessary to assure compliance with established specifications and standards
2016 Ipca Laboratories Limited Failure to have computerized systems with sufficient controls to prevent unauthorized
access or changes to data.
2015 Svizera Labs Private Limited This WHO Notice of Concern addressed deficiencies in documentation
Now
2015 Quest Lifesciences Pvt. Ltd. This WHO Notice of Concern addressed deficiencies in documentation in the GCP
clinical trials area
2015 GVK Biosciences The French Medicines Authority inspected this site in Hyderabad, India and identified
apparent data manipulations conducted in
2015 Apotex Research Private Li mited Data used to release product did not agree with the original data; “trial” injections were
identified; failure to document activities as they occurred; failure to investigate and
report OOS results
2015 Hospira S.p.A Chromatography systems did not have adequate controls to prevent deletion or
modification of raw data files; audit trails were not enabled for the “Test” folder and the
firm was unable to verify what types of test injections were made, who made them or the
date or time of deletion.
33. INSPECTION OBSERVATIONS, WARNING LETTERS, WHO NOTICES OF CONCERN,
AND EU INSPECTIONS
33
19-09-2016Copyright @NishodhSaxena
Warning Letters from US FDA
FISCAL YEAR COMPANY COMMENT
2014 Apotex
Pharmachem
India Pvt Ltd.
Lack of raw data; batches were tested until they passed; OOS events were not reported nor were
they investigated.
2014 Tri farma S.p.A. The firm does not retain laboratory raw data; there is a lack of access control to computer
systems.
2013 Fresenius Kabi
Oncology
This represents the first warning letter to cite the FDASIA definition of adulteration to include
products made in a facility that “delays, denies or limits” an inspection; electronic data could be
altered or deleted; use of “test” or “trial” injections.
2013 Wockhardt Ltd Practice of performing trial injections before the “official” injection; documentation entries not
made as the activities were performed; HPLC data could be deleted from standalone
instruments.
2013 Wockhardt Ltd This letter was the second one in 2013 to cite the new FDASIA power to deem product
adulterated if they are manufactured at a site that “delays, denies or limits” an inspection;
investigators found batch records for 75 lots torn in half in the waste area; HPLC raw data files can
be deleted from the hard drive using the common PC login used by all analysts
2011 Cetero Research This untitled letter was issued to a firm located in the US that conducted BA/BE studies in support
of NDAs and ANDAs. As part of follow up, FDA sent a letter to the firms that contracted with
Cetero Research for BA/BE studies requesting specific information to establish validity of the
BA/BE information in the drug application. We also include one of the forms 483 .
34. INSPECTION OBSERVATIONS, WARNING LETTERS, WHO NOTICES OF CONCERN,
AND EU INSPECTIONS
34
19-09-2016Copyright @NishodhSaxena
Warning Letters from US FDA
FISCAL YEAR COMPANY COMMENT
2009 Ranbaxy, Ohm Laboratories in
Gloversville NY
Analysts were given access to delete data, user account privileges were
inadequate
2008 Ranbaxy, Paonta Sahib Written records were signed by individuals who were not present in the facility on
the day of the signing;
2007 Actavis Totowa LLC, NJ Electronic data files are not checked for accuracy; data discrepancies between
electronic data and data documented in laboratory notebooks.
2006 Wockhardt Failure to maintain complete and accurate records is a repeat deficiency cited at
previous inspections; Logbook did not contain complete and accurate information;
data were not documented at the time of performance.
2006 Ranbaxy, Paonta Sahib Failure to maintain documentation of operation conditions and settings, nor were
complete raw data retained; SOP provides for discarding of data.
2005 Able Laboratories, Cranbury NJ The 15-page form 483 was among the early forms 483 addressing the broad
category of data integrity. The inspection resulted in withdrawal of ~ 50 ANDAs and
the firm is no longer in business.
2000 Schein Pharmaceuticals Warning letter to Schein Pharmaceuticals cites inadequate control over laboratory
computer systems including password control and authority to change data.
35. WHAT ACTIONS COULD FIRMS TAKE?
35
19-09-2016Copyright @NishodhSaxena
• Firms should not assign all computer and software system
responsibilities to the IT groups without engaging a
knowledgeable Quality Unit and other stakeholders as active
partners
• Data management that ensures security and reliability of the
data must be effectively incorporated into the
Pharmaceutical Quality System
• Part 11 is a regulation, just as Parts 210 and 211 are
regulations
36. WHAT ACTIONS COULD FIRMS TAKE?
36
19-09-2016Copyright @NishodhSaxena
• Computer systems should be appropriately developed,
qualified, tested and periodically assessed to ensure they
remain in a validated state
• As part of system validation / re-validation, firms should
perform gap assessments for each GXP computer system
against the requirements of Part 11
• Internal GMP audit programs should always incorporate
assessments of data integrity
37. WHAT ACTIONS COULD FIRMS TAKE?
37
19-09-2016Copyright @NishodhSaxena
• For the QC laboratories, specifically: Laboratory instrument
associated computer systems and other computer systems
should be identified, assessed for their risk to the GMP area,
requirements defined and validated appropriately. Periodic
evaluations should be performed and documented to ensure
they remain in a validated state
• Firms should ensure they are informed regarding current
regulations, guidance and the enforcement environment