The document provides guidance on preparing for and managing an FDA inspection. It outlines steps to take before, during, and after the inspection including conducting a mock inspection, setting up an inspection team, and documenting any deficiencies found. It also provides dos and don'ts for interacting with inspectors such as being prepared, transparent, and avoiding arguments.
In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.
FDA Inspections ( How to Survive an FDA Inspection).pptshaik malangsha
This document provides guidance on how to prepare for and survive a FDA inspection of a clinical trial site. It discusses the different types of inspections, including routine inspections triggered by an application submission and for-cause inspections due to complaints. When receiving notice of an inspection, key steps are to obtain inspection details, notify relevant parties, and prepare documents and staff. During the inspection, FDA inspectors will verify protocol adherence and delegation of duties. Answering questions honestly and avoiding speculation are important.
This document provides guidance on preparing for and responding to FDA inspections and audits. It advises that companies should always be prepared for an audit and not do last minute preparations. During an audit, companies should be prepared to provide documentation, address any previous issues, and communicate openly with inspectors. Following an audit, companies must submit corrective actions to address any issues found and should evaluate their entire quality system to determine the root causes of problems and prevent reoccurrences.
Handling FDA Inspection - Do's and Dont'sArun Purohit
Do not point out errors or try to correct errors in records during an FDA inspection. Focus on being cooperative, providing accurate information in a timely manner, and clarifying any misunderstandings. Avoid arguments.
Preparing For An FDA Inspection - Employee Reviewguest22cdb3
An employee review training session adapted from presentations by former Food and Drug Administration investigators. The presentation includes a team competition based on a popular game show.
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
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
Handling of a fda inspection [compatibility mode]Kiran Kota
The document provides guidance on handling FDA inspections. It discusses key points like signing the FDA Form 482 notice, having subject matter experts available to answer questions, and reviewing documentation before providing it to inspectors. It also describes the FDA's quality system inspection approach, the different inspection classifications (NAI, VAI, OAI), and what is contained in the Establishment Inspection Report provided after an inspection.
In this presentation from Validation Week Europe, Karen Ginsbury discusses the rigors, preparations, strategies, and the do's and the don't of the FDA Inspection process.
FDA Inspections ( How to Survive an FDA Inspection).pptshaik malangsha
This document provides guidance on how to prepare for and survive a FDA inspection of a clinical trial site. It discusses the different types of inspections, including routine inspections triggered by an application submission and for-cause inspections due to complaints. When receiving notice of an inspection, key steps are to obtain inspection details, notify relevant parties, and prepare documents and staff. During the inspection, FDA inspectors will verify protocol adherence and delegation of duties. Answering questions honestly and avoiding speculation are important.
This document provides guidance on preparing for and responding to FDA inspections and audits. It advises that companies should always be prepared for an audit and not do last minute preparations. During an audit, companies should be prepared to provide documentation, address any previous issues, and communicate openly with inspectors. Following an audit, companies must submit corrective actions to address any issues found and should evaluate their entire quality system to determine the root causes of problems and prevent reoccurrences.
Handling FDA Inspection - Do's and Dont'sArun Purohit
Do not point out errors or try to correct errors in records during an FDA inspection. Focus on being cooperative, providing accurate information in a timely manner, and clarifying any misunderstandings. Avoid arguments.
Preparing For An FDA Inspection - Employee Reviewguest22cdb3
An employee review training session adapted from presentations by former Food and Drug Administration investigators. The presentation includes a team competition based on a popular game show.
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
Trends changed from Non compliance to RR --> Gap to RR --> Data Integrity --> DIB --> Smart Audit & Smart Data.
RR = Regulatory Requirements
DIB = Data Integrity Breach
Take a serious Note for Data Integrity whether you are small or big organization. Your Data is the Heart of your business. Regulatory bodies are highly conscious about such issues. For beginners in this path, my small note can help you a lot.
Handling of a fda inspection [compatibility mode]Kiran Kota
The document provides guidance on handling FDA inspections. It discusses key points like signing the FDA Form 482 notice, having subject matter experts available to answer questions, and reviewing documentation before providing it to inspectors. It also describes the FDA's quality system inspection approach, the different inspection classifications (NAI, VAI, OAI), and what is contained in the Establishment Inspection Report provided after an inspection.
The document discusses the FDA's perspective on conducting inspections of clinical trial sites. It describes the goals of FDA inspections as assessing adherence to regulations and confirming safety and ethical treatment of subjects. The FDA conducts three types of inspections: trial oriented, investigator oriented, and bioequivalence inspections. Routine inspections provide advance notice while "for cause" inspections have no notice. Inspections involve reviewing documents, interviewing staff, and inspecting facilities. Common deficiencies found include inaccurate records, failure to follow protocols, and inadequate informed consent processes.
This document provides guidance on preparing for an FDA pre-approval inspection. It discusses what to expect during an inspection, including that inspectors will review documentation for compliance with quality standards. It stresses the importance of managing the inspection through preparation, including conducting internal audits and training personnel. It also recommends designating an inspection team to guide the process and handle document requests. The overall goal is to demonstrate control over quality issues to avoid delays in approval.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/
What your organization should do and should not do during a FDA audit or inspection. For more information go go http://compliance-insight.com/fda-483-warning-letters/fda-483-inspection/
The document defines FDA warning letters and describes the process of FDA inspections that can lead to warning letters. It explains that warning letters notify companies of violations found during inspections and investigations. Companies must promptly correct issues and FDA will check that corrections are adequate. The document also describes different types of warning letters for various regulated industries and how to browse existing warning letters on the FDA website.
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
This document provides guidance on managing an FDA pre-approval inspection (PAI). It outlines how to prepare for an inspection, assign roles and responsibilities, and effectively interact with inspectors. Key aspects include managing the audit room and staging area, escorting inspectors during tours, and understanding dos and don'ts when interacting with inspectors. The overall goal is to demonstrate compliance with FDA regulations and facilitate a successful inspection outcome.
The document discusses preparing for and handling an FDA inspection at a facility. It covers the FDA's authority to inspect facilities and outlines the different types of inspections including routine, concise, follow-up, special, and quality systems reviews. It also discusses the inspection process, providing details on the frequency, duration, and whether inspections are announced or unannounced. Tips are provided on how to prepare for an inspection, what to do during an inspection, and what information is allowed and not allowed to be shared with FDA inspectors.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
- 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.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
This document describes a case study on implementing change control for a Brookfield viscometer that was experiencing frequent spindle speed changes without human handling. This was affecting manufacturing processes and resulting in misleading viscosity readings. A change control process was initiated to address calibration intervals and validation procedures for the viscometer. Documentation was created justifying the need for the change and submitted to the quality assurance team for review and approval. Once approved, the change was implemented.
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.
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
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.
This document provides information on change control procedures for pharmaceutical companies. It defines what constitutes a change, outlines the scope of change control, and describes the change control process. This includes classifying changes as major or minor, evaluating impacts, obtaining approvals, implementing changes, and closing out change controls. Parameters for assessing impact and risk are also listed. The goal is to formally evaluate, document, approve and implement any changes that could affect quality in a validated manner.
The document discusses preparing for and handling FDA validation inspections. It provides tips for pre-inspection activities like internal audits and documentation reviews. It also offers guidance on activities during inspections, such as following SOPs, answering questions, and taking notes. The document concludes with recommendations for post-inspection activities like analyzing findings, developing corrective actions, and submitting a written response.
The document discusses the FDA's perspective on conducting inspections of clinical trial sites. It describes the goals of FDA inspections as assessing adherence to regulations and confirming safety and ethical treatment of subjects. The FDA conducts three types of inspections: trial oriented, investigator oriented, and bioequivalence inspections. Routine inspections provide advance notice while "for cause" inspections have no notice. Inspections involve reviewing documents, interviewing staff, and inspecting facilities. Common deficiencies found include inaccurate records, failure to follow protocols, and inadequate informed consent processes.
This document provides guidance on preparing for an FDA pre-approval inspection. It discusses what to expect during an inspection, including that inspectors will review documentation for compliance with quality standards. It stresses the importance of managing the inspection through preparation, including conducting internal audits and training personnel. It also recommends designating an inspection team to guide the process and handle document requests. The overall goal is to demonstrate control over quality issues to avoid delays in approval.
This presentation is aimed at providing information on automation in the GLP practices in the pharmaceutical industry.
-Standard Operating Procedures.
-Documentation in GALP.
-Logs and Related Forms.
How to succeed when you get a FDA 483 form letter. What to do and how to handle your FDA 483. For more information go to http://compliance-insight.com/fda-483-warning-letters/fda-483-observations/
What your organization should do and should not do during a FDA audit or inspection. For more information go go http://compliance-insight.com/fda-483-warning-letters/fda-483-inspection/
The document defines FDA warning letters and describes the process of FDA inspections that can lead to warning letters. It explains that warning letters notify companies of violations found during inspections and investigations. Companies must promptly correct issues and FDA will check that corrections are adequate. The document also describes different types of warning letters for various regulated industries and how to browse existing warning letters on the FDA website.
The European Commission Health and Consumers Directorate – General has published a draft “GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE”.
The guideline addresses Quality systems, Personnel, Documentation, Order, Procedures, Records, Premises and Equipment, Receipts, Storage , Deliveries to Customers, Transfer of Information and Returns.
Following presentation is prepared by “ Drug Regulations” a non profit organization which provides free online resource to the Pharmaceutical Professional.
This presentation contain introduction to Good Distribution Practices Guideline. and Legal GDP requirements put worldwide.
Good distribution practice (GDP) describes the minimum standards that a wholesale distributor must meet to ensure that the quality and integrity of medicines is maintained throughout the supply chain
Each participant in the distribution chain must agree by the relevant requirements in order to retain the original quality of pharmaceutical products.
Each activity in the distribution of pharmaceutical products shall be carried out according to the principles of Good Distribution Practices (GDP) as applicable.
The risks involved are likely to be of a nature comparable to those that are present in the industrial environment, such as mix-ups, adulteration, contamination, cross-contamination, and spurious.
The guideline addresses
Personnel
Quality System
Premises Warehousing and Storage
Documentation
Traceability
Complaints and Returns
Transportation
This document provides guidance on managing an FDA pre-approval inspection (PAI). It outlines how to prepare for an inspection, assign roles and responsibilities, and effectively interact with inspectors. Key aspects include managing the audit room and staging area, escorting inspectors during tours, and understanding dos and don'ts when interacting with inspectors. The overall goal is to demonstrate compliance with FDA regulations and facilitate a successful inspection outcome.
The document discusses preparing for and handling an FDA inspection at a facility. It covers the FDA's authority to inspect facilities and outlines the different types of inspections including routine, concise, follow-up, special, and quality systems reviews. It also discusses the inspection process, providing details on the frequency, duration, and whether inspections are announced or unannounced. Tips are provided on how to prepare for an inspection, what to do during an inspection, and what information is allowed and not allowed to be shared with FDA inspectors.
This document summarizes the objectives and classification system of the Global Harmonization Task Force (GHTF) for in vitro diagnostic (IVD) medical devices. The GHTF was founded in 1993 to harmonize medical device regulations globally. It aims to facilitate trade while preserving public health. IVD medical devices are classified into 4 risk-based classes (A to D) based on 16 general rules related to device invasiveness, energy use, and disease detection. Class A devices pose the lowest risk while Class D the highest. The classification system aims to ensure regulatory oversight is proportionate to device risk.
- 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.
Lean what 21 CFR Parts 210 and 211 are and how you an implement these regulations in your organization. For more information and tips on compliance go to http://compliance-insight.com/fda-gcp-and-gmp-training/21-cfr-210-211/
This document describes a case study on implementing change control for a Brookfield viscometer that was experiencing frequent spindle speed changes without human handling. This was affecting manufacturing processes and resulting in misleading viscosity readings. A change control process was initiated to address calibration intervals and validation procedures for the viscometer. Documentation was created justifying the need for the change and submitted to the quality assurance team for review and approval. Once approved, the change was implemented.
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.
A guide for how to survive a FDA Warning letter. So you got at FDA 483 and now you have a FDA Warning Letter, learn how to survive the storm. For more information go to http://compliance-insight.com/fda-483-warning-letters/
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.
This document provides information on change control procedures for pharmaceutical companies. It defines what constitutes a change, outlines the scope of change control, and describes the change control process. This includes classifying changes as major or minor, evaluating impacts, obtaining approvals, implementing changes, and closing out change controls. Parameters for assessing impact and risk are also listed. The goal is to formally evaluate, document, approve and implement any changes that could affect quality in a validated manner.
The document discusses preparing for and handling FDA validation inspections. It provides tips for pre-inspection activities like internal audits and documentation reviews. It also offers guidance on activities during inspections, such as following SOPs, answering questions, and taking notes. The document concludes with recommendations for post-inspection activities like analyzing findings, developing corrective actions, and submitting a written response.
The document discusses preparing for and handling FDA validation inspections. It provides tips for pre-inspection activities like internal audits and documentation reviews. It also offers guidance on activities during inspections, such as following SOPs, answering questions, and taking notes. The document concludes with recommendations for post-inspection activities like analyzing findings, developing corrective actions, and submitting a written response.
The document provides details on conducting quality audits, including:
1) An overview of audit preparation such as developing an audit plan, selecting auditors, and preparing documentation for review.
2) Guidelines for performing the audit such as conducting an opening meeting, touring the site, reviewing documentation, and holding a daily wrap-up meeting.
3) Details on audit techniques including asking questions, classifying observations, and conducting a close-out meeting to discuss audit findings.
The document outlines the key aspects of conducting a quality auditing training course, including:
1) The background and basics of auditing, types of audits, auditor conduct and necessary skills, audit preparation and planning, performing the audit, and developing an audit report and follow up.
2) It discusses the importance of effective communication, maintaining objectivity and professionalism, and properly preparing, planning and executing audits.
3) The document provides guidance on selecting auditors, developing an audit plan and schedule, preparing checklists and understanding the audit site prior to the audit.
The document provides details on conducting quality audits, including:
1) An overview of audit preparation such as developing an audit plan, selecting auditors, and preparing the auditees.
2) Guidelines for performing the audit such as conducting an opening meeting, touring the site, questioning techniques, and daily wrap-ups.
3) Details on audit report out including classifying observations as critical, major, or minor and conducting a close-out meeting.
1) The document discusses various types of audits that pharmaceutical companies may face, including internal audits, customer audits, regulatory audits, and other certifications audits.
2) It emphasizes the importance of being prepared for audits through documentation review, subject matter expert availability, facility cleanliness, and employee training. Proper preparation is important for business continuity and regulatory compliance.
3) The document provides tips for successfully interacting with auditors, including welcoming them, being available to answer questions, promptly providing requested documents, maintaining a positive attitude, and following up after the audit to close out any findings. Proper conduct during audits can help avoid issues and ensure future audit success.
The document provides guidance on preparing for and undergoing a regulatory inspection of a clinical trial site. It outlines the objectives of inspections, why sites may be selected, who will conduct the inspection, what materials will be reviewed, and tips for how to interact with inspectors in an open and cooperative manner. The inspection process typically involves an opening meeting, personnel interviews, document reviews, and a closing meeting and can take around one week to complete. Proper preparation is key to facilitating a smooth inspection.
Deviation, OOS & complaint investigation and CAPADr. Amsavel A
This document discusses deviation, out-of-specification (OOS), and complaint investigations and corrective and preventive action (CAPA). It defines key terms like nonconformity, corrective action, and preventive action. It describes the requirements for investigations per 21 CFR regulations. Common investigation tools like root cause analysis, 5 whys, fishbone diagrams, and fault tree analysis are explained. The document stresses identifying the root cause, avoiding focus on individuals, and verifying the effectiveness of CAPA.
The document provides guidance on preparing for and managing regulatory, customer, and internal audits. It discusses the importance of having the right audit preparation strategies and teams in place. Key steps include identifying subject matter experts, designating roles like escorts and note-takers, conducting mock audits, and collecting information about upcoming auditors. The document emphasizes being prepared at all times rather than just when audits occur.
Take control of your company’s compliance by knowing your rights and responsibilities. Learn strategies for managing an inspection when an OSHA inspector is on-site. Score 10 practical tips on how crane and rigging companies can boost their compliance efforts and minimize their risk.
Speaker: Michael Rubin, Partner Attorney, Goldberg Segalla LLP
The document outlines an agenda for a leadership review presentation on preparing for and managing an FDA inspection. The agenda includes introductions to FDA inspections, critical cGMP elements, job performance scenarios and role plays, and a review section. Key points covered are the types of FDA inspections, how deficiencies are cited, leadership roles and responsibilities during inspections, readiness checks, and responding to 483 observations.
Good Documentation Practice (GDocP — or GRK for Good Recordkeeping) is an essential component of your overall pharmaceutical quality system (PQS) and quality risk management strategies (QRM).
new guidance on good data management was discussed and its development
recommended. The participants included national inspectors and specialists
in the various agenda topics, as well as staff of the Prequalification Team
(PQT)–Inspections
Good laboratory practices (GLP) provide a framework for conducting laboratory studies in a planned, monitored and documented manner. GLP was created in response to issues like poor laboratory practices, improperly calibrated equipment and inaccurate study reports. Key aspects of GLP include designated roles for a study director and quality assurance unit, requirements for qualified personnel, standard operating procedures, control of equipment and materials, and archiving of raw data. Following GLP aims to ensure the validity and integrity of nonclinical safety studies and promote international acceptance of study results.
The document discusses Good Laboratory Practices (GLP). It provides background on GLP, noting that it is an FDA regulation created in 1978 in response to cases of poor laboratory practices and fraudulent activities. GLP provides a framework for planning, performing, monitoring, recording, and reporting laboratory studies. Key aspects of GLP include requirements for facilities, equipment, test systems, standard operating procedures, personnel responsibilities, quality assurance programs, and record keeping. Adherence to GLP aims to ensure the quality and integrity of data submitted to regulatory agencies.
Introduction to Internal Quality System AuditingJeffStevens
This document provides guidance on conducting audits according to basic auditing assumptions and definitions. It outlines the responsibilities of auditors and auditees, as well as qualifications needed by auditors. Guidelines are provided for audit quality assurance, working papers, lead auditor responsibilities, interview tips, audit plans, reports, techniques for understanding quality management systems, auditor attributes, inquiry categories, interview considerations, principles of audit reporting, process requirements, and sampling. The document describes elements of a successful audit from planning through closure.
An inspection is a snapshot of the physical conditions observed at the site at a particular point in time, whereas an audit is a comprehensive evaluation of the entire program. Learn what it takes to manage an effective laboratory inspection and audit program in an effort to maintain compliance.
This document provides an overview of Good Laboratory Practices (GLP). It states that GLP is an FDA regulation that establishes a framework for conducting laboratory studies. The document discusses the history of GLP, including how it originated in the US in 1978 in response to cases of poor laboratory practices. It describes the objectives and mission of GLP to ensure data integrity and traceability. Key aspects of GLP like standard operating procedures, record keeping, and facility certification are summarized. Consequences of noncompliance, such as disqualification and inability to conduct studies, are also outlined.
administering test.pptx ppt ppt for lifeswatisheth8
The document discusses best practices for administering written tests. It emphasizes that test administrators should create a calm testing environment and be well-prepared. They should ensure uniform testing conditions by preparing the room in advance and having clear, standardized administration procedures. During the test, administrators should distribute materials properly, address questions, and monitor for issues while maintaining security of test materials and confidentiality of results.
This document provides guidance for ensuring sterility in the manufacture of sterile medicinal products through a contamination control strategy (CCS). The CCS should establish robust assurance of contamination prevention from microbial, endotoxin/pyrogen and particulate sources. It involves identifying risks to product quality using quality risk management and putting in place controls like facility design, equipment qualification, environmental monitoring, personnel training and change control to minimize these risks. The CCS must describe all elements of the manufacturing process and be reviewed periodically for effectiveness in assuring sterility of the final product.
The document summarizes an integrated training program on the implementation of ICH Q8, Q9, and Q10 guidelines. It provides background on the ICH, including its 20-year history of harmonizing pharmaceutical regulations between countries. It then describes the "new quality paradigm" established in ICH Q8, Q9, and Q10, focusing on building quality in throughout the product lifecycle using an integrated approach including quality risk management and science-based decisions. The training program aims to provide clarity on implementing these new guidelines through workshops for both regulators and industry.
This document discusses potential applications of quality risk management principles from ICH Q9, focusing on using risk management approaches for facilities, equipment, and utilities. It provides examples of how a risk-based approach could be used to assess facility needs for manufacturing certain medicinal products. The examples describe evaluating risks related to the severity of potential harm, the manufacturing process, and establishing risk control measures. A variety of options for dedicated facilities and equipment arrangements as well as operational solutions for controlling risks are outlined. The document stresses that risk-based criteria like potential safety risks to patients and controls to minimize cross-contamination should be considered.
This document discusses potential applications of quality risk management as outlined in ICH Q9, including using it to identify potential root causes when investigating out of specification laboratory results, to evaluate the adequacy of storage and testing conditions when setting retest or expiration dates, and to challenge results from use tests and stress tests. It also notes that quality risk management could be applied as part of laboratory control and stability testing by industry and regulatory authorities.
The document discusses potential applications of quality risk management principles from ICH Q9 during pharmaceutical development and manufacturing. It provides examples of how risk management could be applied to various stages of development including facilities, materials management, production, packaging and labeling. The slides describe using risk management to design quality into products and manufacturing processes, establish specifications, and control critical process parameters. Risk management is also described as a way to gain process understanding, decrease variability, and assess the need for additional studies.
This document provides an overview of Failure Mode and Effects Analysis (FMEA) as a quality risk management tool. It discusses how FMEA can be used to evaluate potential failure modes in processes, identify likely effects on product quality, and prioritize risks. The document provides guidance on performing an FMEA, including establishing a team, identifying failure modes and causes, characterizing severity, probability and detectability of risks, defining actions, and documenting results. Examples of applying FMEA to a drying process and granulation process step are also presented to illustrate the methodology.
This document discusses data quality, integrity, and FDA requirements for laboratories. It provides definitions for data quality and integrity, and outlines the ALCOA principles. The presentation notes that laboratory data is important for ensuring compliance and can reveal quality problems. Common data integrity issues found in electronic records include trial sample analysis, deletion/overwriting of data, testing into compliance, backdoor manipulation, and physical manipulation. Thorough and unbiased out-of-sample investigations are important, and averaging or disregarding out-of-spec results violates requirements.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Kosmoderma Academy, a leading institution in the field of dermatology and aesthetics, offers comprehensive courses in cosmetology and trichology. Our specialized courses on PRP (Hair), DR+Growth Factor, GFC, and Qr678 are designed to equip practitioners with advanced skills and knowledge to excel in hair restoration and growth treatments.
Are you looking for a long-lasting solution to your missing tooth?
Dental implants are the most common type of method for replacing the missing tooth. Unlike dentures or bridges, implants are surgically placed in the jawbone. In layman’s terms, a dental implant is similar to the natural root of the tooth. It offers a stable foundation for the artificial tooth giving it the look, feel, and function similar to the natural tooth.
- Video recording of this lecture in English language: https://youtu.be/Pt1nA32sdHQ
- Video recording of this lecture in Arabic language: https://youtu.be/uFdc9F0rlP0
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
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2. FDA INSPECTION READINESS
• Before the inspection
• Set up for Inspection (Inspection team / Room setup)
• Opening Meeting
FDA Readiness
Tour of the facility
Do’s and Don’t s During the inspection
Typical Questions During Inspection
Daily wrap-up and Final close-out
After the inspection / Next Steps
3. FDA INSPECTION READINESS
Before Inspection:
Conduct Mock Inspection / Gap Analysis
Create CAPA Plan for any Gaps
Execute remediation
Continuous walk through of the facility / cleanliness of the facility
Be pro-active and Be Prepared / Know your job
Do not shy away or hide from the process.
Have SMEs trained to address inspectors questions
4. FDA INSPECTION READINESS
What will they look at?
Validation, if compliant with CFR Part 11
Computers
Appropriately approved and followed / periodical review
Procedures
Resolved and closed as per internal procedure
Complaints
Removed from inventory and isolated as per procedure
Rejected batches
Process / reference standards / method validation / method transfer /
raw data
Laboratory controls
Storage & security / usage / consolidation
Labels, Components
Testing / QA oversight
In-process materials
Equipment / E-system / Computer software / Methods / Cleaning
Validation processes
Testing / Release of the final product
Finished/released
materials
Appropriately assigned / Reviewed and approved
Logbooks, records and
documents
Buildings, equipment, materials, cleaning procedures, HVAC, etc.
Overall facility
5. FDA INSPECTION READINESS
Typical
Onsite
Inspection
Team
Quality Head (Host)
Scribers (typically 2 –
front and back room)
Document Controller
SMEs for each
department
Quality control Laboratory
Production and packaging
Facilities and Warehouse
IT
Document Runners
6. FDA INSPECTION READINESS
Inspection Front Room
Presentation Name | CONFIDENTIAL
Scriber 1 Scriber 2
Quality Head
(Host)
Auditor 1 Auditor 2
Document
Controller
Requested
Document Files
Index cards
with Request #
Request #
Documents Being
Reviewed
Document
Runner
7. FDA INSPECTION READINESS
Inspection Back Room
Presentation Name | CONFIDENTIAL
Document Runner
to
Front Room
SMEs
Requested
Document Files
Document
Request #
Backroom
Scriber 1
Backroom
Scriber 2
Customer
SMEs
8. FDA INSPECTION READINESS
Opening Meeting – Short
Presentation
Introduction of the management, Quality
staff and employee present in the room
Organizational Chart (Indicate who is
the management)
Presentation about the facility/layout,
plan tour, hour of operations
9. FDA INSPECTION READINESS
Managing the inspection…
• Control documents provided to the inspector
• Keep log of requests and their status… Mark
“Confidential” and “Copy” to all copied
documents provided
• Review the requested record before sending
into the room for the investigator. Check that
the record is the one asked for.
• Send only the record and not the entire file.
• Check for any missing signatures or entries
or missing pages
10. FACILITY TOUR DURING INSPECTION
• Identify key QA and respective department
SMEs to escort Inspectors
• Escort the inspectors at all times
• Tour – flow the material and production
process
• Incoming materials / warehouse (raw
materials, packaging material)
• Quarantine / Approve material area
• Production (manufacturing to finish goods
area)
• QC Lab
Tour of the facility with Inspectors
11. FACILITY TOUR DURING INSPECTION
• Restrict conversations in common areas and/or to the area
only being toured
• Be prepared to show to which process or relevent SOP for
the work performed in the area.
• Questions –
• Address only if the available information is accurate
• Ensure you understand the questions before answering.
• Take note of the questions asked or document requested
• Take note of any document reviewed by the inspectors
• Take note of any employees interviewed during the
walkthrough
• Always be truthful, if information not available or not known,
it’s okay to say “I don’t know, let me find out”
Tour of the facility with Tour of the facility with
Inspectors (continues)
12. HANDLING FDA INSPECTION - DO'S
Do’s Be confident
Be well dressed and neat.
Be presentable
Be decent and polite
Be courteous and professional at all times
Correct all errors/miscommunications as
soon as possible
13. HANDLING FDA INSPECTION - DO'S
Do’s
Require that all requests from the inspector go
through your inspection team
Provide documents in an accurate and timely manner
Handle document requests with care, ensure that
only requested document is provided
Review requested document prior to presenting to
the inspector ensure it’s completion
Limit the inspector’s access to the records, facilities
and materials that are subject to inspection
14. HANDLING FDA INSPECTION - DO'S
Do’s
Check that no undue paper is appended to the record.
Ask for clarification when necessary
Avoid undue traffic in and out of the room.
Remove records which have been reviewed from the room
Show one record at one time
Have all records organized and available
Have all relevant documents/raw data readily accessible –
preferably assembled in one central location.
Be very familiar with content and location of all reports/data, SOPs
etc.
Avoid Long delays in responding to questions
15. HANDLING FDA INSPECTION - DO'S
Do’s
Make thorough notes of
comments/concerns/ deficiencies
pointed out by the inspector.
However don’t pass slips / notes to each
other.
Clarify or attempt to resolve issues
as it becomes known.
Be cooperative with the investigator
to the extent possible, but politely
disagree when appropriate
Be brief in what you say “no” to any
questions
Try to Develop a “Relationship”. You
know the product and process
better than FDA and that needs to
be conveyed.
16. HANDLING FDA INSPECTION - DO'S
When a
question
is
asked…
Take a deep breath
Listen carefully to the Inspector’s questions
Pause and formulate a proper response
Answer only after the question is fully stated.
Request clarification to questions not understood
Answer only what was asked
Provide a clear, concise, and honest answer
Only answer questions within your job responsibilities
otherwise direct the question to “Subject Matter Experts”
17. HANDLING FDA INSPECTION - DO'S
When a
question
is
asked…
Speak slowly and clearly-one word at a time
Keep unnecessary conversation to a
minimum
Answer briefly to the question only
Answer only if you are sure.
Communicate clearly and effectively
Focus on positives
18. HANDLING FDA INSPECTION - DO'S
DO’s
Assume a friendly, cooperative attitude - but do
not overdo it.
Avoid creating an adversary relationship. Project
an attitude of confidence and professionalism.
If management is seen as "uncooperative," the
investigator may well become suspicious and
more zealous.
Review pertinent plant policies e.g., policies
pertaining to cameras, recorders, wearing apparel,
and safety equipment during the opening interview
Presentation Name | CONFIDENTIAL
19. HANDLING FDA INSPECTION - DO'S
DO’s
Acknowledge and document areas that you know need
development.
If the inspector is ‘digging’ or asking the same basic
question, provide more information as answers may not be
complete.
Talk about what is and not what might be or should be.
If a problem has surfaced, point out where GMP and quality
system controls have worked and how improvements have
been made.
Often, it is appropriate to include a plan for corrective action.
Inspectors wants to see that management is taking these
issues seriously.
Presentation Name | CONFIDENTIAL
20. HANDLING FDA INSPECTION – DON’TS
DON’Ts
Do not try to “Snow” the inspector, wrong information is
worse than no information.
Don’t try to control the conversation
Don’t try to lead the inspection
Don’t try to change the agenda
Avoid language using typically, normally, generally, and
usually, as possible
Guess, lie, deny the obvious, or make misleading
statements
Engage in unconstructive argument. (Avoid win/lose or
legalistic confrontations.)
Presentation Name | CONFIDENTIAL
21. HANDLING FDA INSPECTION – DON’TS
DON’Ts
Do not write and implement Standard Operating
Procedure that are overly complex and above the
required standards.
You will be inspected to your SOPs as well as the
regulatory requirements.
Failing to meet your SOPs will result in inspection
finding even if you are meeting the regulatory
requirements.
Don’t write rigid SOPs instead where possible use
‘guidance’
Presentation Name | CONFIDENTIAL
22. HANDLING FDA INSPECTION – DON’TS
DON’Ts
Don’t try any distraction techniques
Speak unless spoken to or questions asked
Attempt to answer “What if?” questions or
hypothetical questions
Become argumentative or, worse, hostile or make
threatening remarks.
Engage in arguments with peers in the presence
of inspectors
Presentation Name | CONFIDENTIAL
23. HANDLING FDA INSPECTION – DON’TS
DON’Ts
Don’ts Allow inspectors to go through your files on their
own. Ask them what they want and provide it for them.
Refuse appropriate requests from inspectors, but try to
narrow the scope of the request when possible
Do not try to hinder the progress of the Auditor by time
consuming idle conversations, lengthy presentations or
non-relevant alternate agendas
Don’t waste inspector’s time
Do not challenge the auditor’s understanding of the
requirements and regulations.
Presentation Name | CONFIDENTIAL
24. HANDLING FDA INSPECTION – DON’TS
DON’Ts
Ask questions to the auditor
Show off your knowledge.
Defend your answer by giving reference of
guideline or book
Get aggressive or be ‘clever’
Joke with the investigator
Say that something is impossible or couldn’t
happen. (This is a red flag that challenges the
inspector to find a way it could happen.)
Chat in places the auditor may be i.e. toilets,
corridors etc.
Presentation Name | CONFIDENTIAL
25. HANDLING FDA INSPECTION – DON’TS
DON’Ts
Correct other people in front of the Inspector
Do not initial/sign any error in front of the
inspectors
Interrupt someone else’s answer
Interrupt the Inspector’s comments and
explanations
Provide your opinions
Answer for someone else
Presentation Name | CONFIDENTIAL
26. HANDLING FDA INSPECTION – DON’TS
DON’Ts
Don’t have food in the lab
Have clutter in your work area
Quote what the SOP says, unless you’re 200%
certain you know what you’re talking about
Be intimidated or defensive
Don’t leave documents out on your desk.
Presentation Name | CONFIDENTIAL
27. HANDLING FDA INSPECTION – DON’TS
DON’Ts
Leave inspectors alone while they are in your plant
Tell inspectors that records are unavailable. You can say that
you cannot locate the record
Tell inspectors they are being unreasonable (even when
they are)
Ask questions such as, “Where does it say we have to do
that?” Their response will likely be “Where does it say that
you don’t?”
Do not answer questions which lie outside the authority of
the Inspector (sales data, personnel information relating to
salaries, performance reviews, etc)
Presentation Name | CONFIDENTIAL
28. HANDLING FDA INSPECTION – DON’TS
DON’Ts
When reviewing Records
Point out errors
Correct errors during the review
Comment or “apologize” for the quality of the data
Comment on plans to improve recordkeeping
practices, unless criticized by the Investigator
Presentation Name | CONFIDENTIAL
29. HANDLING FDA INSPECTION – DON’TS
Choose your responses correctly “To be
really honest with you ………..” OR “To
tell you the truth ………”
Unofficially…
Off the record…
Presentation Name | CONFIDENTIAL
30. HANDLING FDA INSPECTION – DON’TS
Be wary of the “Long silence technique”
Auditor asks you a question
You answer
Auditor listens
Auditor maintains a long silence (purposely)
You become anxious to break the silence
You add more to the answers (mostly unwanted!)
Auditor got enough to grill you!
Don’t be over anxious to break the silence, answer only to the
point, not a word more
Presentation Name | CONFIDENTIAL
31. TYPICAL QUESTIONS DURING INSPECTION…
Question to expect…
Quality Policy – What it is and how is it applied in the facility
quality system?
Job responsibility – how do you know what to do on your job?
Deviations, Investigations, OOS, Complaints – How many in a
quarter or past two years and how do you manage them?
Relevant SOPs.
Supplier Quality or How vendors are qualified and audited?
Management Review, Frequency? Agenda? Participants?
Training – How are employees trained for their job
responsibilities and process for requalifications?
Laboratory – Instrument qualification, validation and/or
calibration, test method validation
Data Integrity Policy – how data is secured and ensure accuracy
of it?
Presentation Name | CONFIDENTIAL
32. MANAGING THE INSPECTION – DAILY WRAP UP
Daily Wrap up:
Regroup and try to address the concerns /
comments for the day
Ask the inspector if there are any open issues for
that day or any concerns not address during the
day
Confirm they are done with the topic
Confirm next day start time
Collect request of documents that they would like
to review next day, so all can be available first
thing next day
Presentation Name | CONFIDENTIAL
33. MANAGING THE INSPECTION – FINAL CLOSE OUT
Final Close-out:
Request a closing meeting – Even it no issues found
Confirm the date / time with the inspector and invite
management
This is not the time to argue with the inspector
Ask questions as needed for any calification of any issues
found or clear understanding of any concerns presented
Request for final report or list of observation/findings from
the inspectors
Find out response deadline and next steps…
Presentation Name | CONFIDENTIAL
34. AFTER INSPECTION / NEXT STEPS
After Inspection Steps:
Regroup with internal respective SMEs, and the
management
Clearly understand any findings or concerns raised by the
inspectors at the close-out
Initiate discussion on drafting constructive response with
clear timeline and plan for any corrective actions needed
Submit the response within allowed deadline. Do not wait for
last minute submission.
Goal is continuous improvement
Presentation Name | CONFIDENTIAL
35. Be prepared to MANAGE the inspection –
Establish roles and responsibilities before the
inspection – Have the necessary resources to
accommodate the number of inspectors
Presentation Name | CONFIDENTIAL