The document discusses FDA regulations on electronic records and electronic signatures (Part 11). It summarizes that Part 11 establishes criteria for electronic records and signatures to be considered equivalent to paper records. It defines controls for closed and open systems, including limiting access, operational checks, authority checks, device checks, education for system users, policies for electronic signatures, and controls over documentation and data.
DIA 2015 - EMR/EHR Clinical Data Intergration with EDC SystemsClinCapture
It has been a longstanding challenge to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems for clinical studies and trials.
Integration between disparate systems can be done in many ways. Any two systems can be integrated given enough time and money. However, if there is to be wide-scale integration between applications used by clinicians at their practice or in the hospital, it requires the formation and use of standards for the structure and content of data as well as the transport of data between two systems.
A historic problem has been the lack of EMR adoption, particularly in physician offices. Thankfully, this is improving dramatically, something I will touch on later.
There is also a historic problem that Case Report Forms and the databases that contain them in EDC systems are routinely not designed from the start with standardized labels, content or structure. More adoption of the CDISC standards, such as C-DASH (clinical data acquisition standards harmonization) which dictates structure and content, and ODM (operational data model) which is an XML rendering of the CDASH CRFs.. If you take anything away from this talk, please ensure any data capture you do within an EDC system going forward meets the ODM model.
Patient matching between systems is important. There is a whole industry for Community and Master Patient Indexes to link records in disparate systems to the same patient. This gets even more complex when the patients are to be kept anonymous or the studies are blinded.
Lastly, moving data across systems is a challenge. There are two primary methods – 1) asynchronous file transfer in conjunction with an ETL, or 2) APIs where one system is inquiring in real time into another application for data. The latter is usually regarded as a more robust integration, but without standard APIs these are one off solutions. The former, using ETL, requires the sending and receiving applications be able to communicate
Community pharmacy anticoagulation monitoring service, the Canterbury approach. Presented by Vanessa Buchan, Canterbury Health Laboratories, at HINZ 2014, 11 November 2014, 12pm, Marlborough Room
It has been a longstanding challenge to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems for clinical studies and trials.
The challenges include:
Low adoption rates of EMRs in physician practices
Lack of interoperability tools provided by vendors to extract data from EMRs
Lack of standardized payload (content) and method of delivering (transport) from different EMRs to the EDC systems
All subjects of clinical studies not being part of the same health system and therefore same EMR
Lack of automated methods for identifying the same patient between EMRs and EDC systems
Inability to map and translate the EMR data into CRFs (case report forms) of the EDC systems
These hurdles have been so high that the task has rarely been attempted in earnest, let alone accomplished in any significant way. That is until recently. How are these challenges being overcome today? What changes have allowed this integration to be to considered and implement today? The answer is: lots!
Wireless Infusion Pumps: Securing Hospitals’ Most Ubiquitous Medical DevicePriyanka Aash
Imagine being dependent on a wireless infusion pump to receive the correct dosage of life-supporting medication. Now imagine the implications, were that pump to be maliciously hacked. In this session learn more about how to successfully secure these medical devices, based on work being conducted at the National Cybersecurity Center of Excellence (NCCoE) with premier health care organizations.
(Source: RSA USA 2016-San Francisco)
DIA 2015 - EMR/EHR Clinical Data Intergration with EDC SystemsClinCapture
It has been a longstanding challenge to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems for clinical studies and trials.
Integration between disparate systems can be done in many ways. Any two systems can be integrated given enough time and money. However, if there is to be wide-scale integration between applications used by clinicians at their practice or in the hospital, it requires the formation and use of standards for the structure and content of data as well as the transport of data between two systems.
A historic problem has been the lack of EMR adoption, particularly in physician offices. Thankfully, this is improving dramatically, something I will touch on later.
There is also a historic problem that Case Report Forms and the databases that contain them in EDC systems are routinely not designed from the start with standardized labels, content or structure. More adoption of the CDISC standards, such as C-DASH (clinical data acquisition standards harmonization) which dictates structure and content, and ODM (operational data model) which is an XML rendering of the CDASH CRFs.. If you take anything away from this talk, please ensure any data capture you do within an EDC system going forward meets the ODM model.
Patient matching between systems is important. There is a whole industry for Community and Master Patient Indexes to link records in disparate systems to the same patient. This gets even more complex when the patients are to be kept anonymous or the studies are blinded.
Lastly, moving data across systems is a challenge. There are two primary methods – 1) asynchronous file transfer in conjunction with an ETL, or 2) APIs where one system is inquiring in real time into another application for data. The latter is usually regarded as a more robust integration, but without standard APIs these are one off solutions. The former, using ETL, requires the sending and receiving applications be able to communicate
Community pharmacy anticoagulation monitoring service, the Canterbury approach. Presented by Vanessa Buchan, Canterbury Health Laboratories, at HINZ 2014, 11 November 2014, 12pm, Marlborough Room
It has been a longstanding challenge to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems for clinical studies and trials.
The challenges include:
Low adoption rates of EMRs in physician practices
Lack of interoperability tools provided by vendors to extract data from EMRs
Lack of standardized payload (content) and method of delivering (transport) from different EMRs to the EDC systems
All subjects of clinical studies not being part of the same health system and therefore same EMR
Lack of automated methods for identifying the same patient between EMRs and EDC systems
Inability to map and translate the EMR data into CRFs (case report forms) of the EDC systems
These hurdles have been so high that the task has rarely been attempted in earnest, let alone accomplished in any significant way. That is until recently. How are these challenges being overcome today? What changes have allowed this integration to be to considered and implement today? The answer is: lots!
Wireless Infusion Pumps: Securing Hospitals’ Most Ubiquitous Medical DevicePriyanka Aash
Imagine being dependent on a wireless infusion pump to receive the correct dosage of life-supporting medication. Now imagine the implications, were that pump to be maliciously hacked. In this session learn more about how to successfully secure these medical devices, based on work being conducted at the National Cybersecurity Center of Excellence (NCCoE) with premier health care organizations.
(Source: RSA USA 2016-San Francisco)
Use and future on telemedicine | Diu Title defense Fall 2020REZAUL KARIM REFATH
Use and future on telemedicine | Diu Title defense Fall 2020
Contact with me: Rezaul15-1871@diu.edu.bd
Do not copy the whole slide, It will kill your creativity
Connecting Your Operator Console for Smarter Clinical CommunicationsSpok
Did you know that you can do more when your clinical communication solutions are connected to the contact center? In this webinar we explore the power of a connected operator console in enabling smarter clinical communications, and ultimately better patient outcomes.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
Gain the latest insight (2013) into 21 CFR Part 11 Compliance from AITalent's latest Webinar.
Discover:
Part 11 – What it is not, the myths.
Part 11 – What it is, the facts.
Part 11 – What does the future hold?
Find out more: www.aitalent.co.uk
21 CFR Part 11
- Introduction
- Part 11: Electronic Records & Electronic Signatures :-
Subpart A - General Provisions
Subpart B - Electronic Records Subpart C – Electronic Signatures Good Manufacturing Practices Quality Management Documentation
- Range of requirements for written procedures Standard operating procedures (SOPs)
- Format for standard operating procedures (SOPs) Forms for recording data
- Master formulae
- References
Thank you !!!
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA) that establishes requirements for electronic records and electronic signatures in the context of FDA-regulated industries, including pharmaceuticals, biotechnology, medical devices, and food and beverage. The regulation is titled "Electronic Records; Electronic Signatures" and is intended to ensure the reliability, integrity, and authenticity of electronic records and signatures used in FDA-regulated activities.
Use and future on telemedicine | Diu Title defense Fall 2020REZAUL KARIM REFATH
Use and future on telemedicine | Diu Title defense Fall 2020
Contact with me: Rezaul15-1871@diu.edu.bd
Do not copy the whole slide, It will kill your creativity
Connecting Your Operator Console for Smarter Clinical CommunicationsSpok
Did you know that you can do more when your clinical communication solutions are connected to the contact center? In this webinar we explore the power of a connected operator console in enabling smarter clinical communications, and ultimately better patient outcomes.
This presentation describes approaches for software validation used to automate laboratory research procedures, consolidate data collection and analysis and/or run sophisticated QC or manufacturing operations.
Several approaches to software validation exist and may be appropriate for a specific project.
The scope of any validation effort depends upon a number of factors
Size and complexity of the software,
Origin of the software (custom vs. off-the-shelf) and
Whether the functions are critical or non-critical in nature.
By effectively planning the process, validation time and resources can be reduced while meeting regulatory requirements.
Gain the latest insight (2013) into 21 CFR Part 11 Compliance from AITalent's latest Webinar.
Discover:
Part 11 – What it is not, the myths.
Part 11 – What it is, the facts.
Part 11 – What does the future hold?
Find out more: www.aitalent.co.uk
21 CFR Part 11
- Introduction
- Part 11: Electronic Records & Electronic Signatures :-
Subpart A - General Provisions
Subpart B - Electronic Records Subpart C – Electronic Signatures Good Manufacturing Practices Quality Management Documentation
- Range of requirements for written procedures Standard operating procedures (SOPs)
- Format for standard operating procedures (SOPs) Forms for recording data
- Master formulae
- References
Thank you !!!
University Institute of Pharmaceutical Sciences is a flag bearer of excellence in Pharmaceutical education and research in the country. Here is another initiative to make study material available to everyone worldwide. Based on the new PCI guidelines and syllabus here we have a presentation dealing with the 21 code of federal regulation Part 11.
Thank you for reading.
Hope it was of help to you.
UIPS,PU team
What is 21 CFR Part 11?:
21 CFR Part 11:
Allow the industry to use electronic records and signatures alternatively to paper records and hand-written signatures
21 CFR Part 11 applies:
To all FDA regulated environments
When using computers in the creation, modification, archiving, retrieval or transmission of data or records
To records required by predicate rules – GLP, GCP, GMP – that impact patient safety
To new and old systems
Purpose of Part 11
Ensure data is not corrupted or lost
Data is secure
Approvals cannot be repudiated
Changes to data can be traced
Attempts to falsify records are made difficult and can be detected
Types of Systems
Two types of systems that come under 21 CFR Part 11 – closed and open systems
Closed and Open Systems:
What is a Closed system?
A system to which access is controlled by person responsible for electronic records stored on it
What is an Open system?
A system to which access is not controlled by those responsible for the electronic records stored on it
21 CFR Part 11 Requirements:
21 CFR Part 11 lists the following controls for closed systems:
Validation
Device checks
Operational system checks
Accurate and complete copies
Accurate and steady retrieval
Limited access to systems and data
Authority checks
Electronic audit trail
Training/qualification of personnel
Accountability of signatures
Control over system documentation
Digital Signatures :
Use of digital signatures for open systems
Electronic Signatures
Requirements for signed electronic records
Linking records to signatures
21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA) that establishes requirements for electronic records and electronic signatures in the context of FDA-regulated industries, including pharmaceuticals, biotechnology, medical devices, and food and beverage. The regulation is titled "Electronic Records; Electronic Signatures" and is intended to ensure the reliability, integrity, and authenticity of electronic records and signatures used in FDA-regulated activities.
Achieving 21 Code of Federal Regulations (CFR) Part11SamuelP9
Download Free Whitepaper on Achieving 21 Code of Federal Regulations (CFR) Part11 Compliance with SimplicityChrom Chromatographic Data System (CDS):
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Regulatory Concerns When Running Virtual/Paperless Clinical TrialsTarget Health, Inc.
With drug and device manufacturers and the U.S. Food and Drug Administration (FDA) supplying much of the push, so-called paperless clinical trials are gaining momentum. In this eClinical Forum webinar, Dr. Jules Mitchel, President of Target Health, facilitated the discussion on the future landscape and regulatory concerns of paperless clinical trials and clinical trial design incorporating mobile tools.
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.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
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Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
2. 1. Title 21 of the Code of Federal Regulations that
establishes the United States Food and Drug
Administration (FDA) regulations on electronic
records and electronic signatures (ERES).
2. Part 11 as it is commonly called, defines the criteria
under which electronic records and electronic
signatures are considered trustworthy, reliable, and
equivalent to paper records.
3. 1. In March of 1997, FDA issued final part 11 regulations that
provide criteria for acceptance by FDA, under certain
circumstances, of electronic records, electronic signatures
and handwritten signatures executed to electronic records
as equivalent to paper records and handwritten signatures
executed on paper. These regulations, which apply to all
FDA program areas, were intended to permit the widest
possible use of electronic technology, compatible with FDA's
responsibility to protect the public health.
4. Subpart A – General Provisions
• Scope
• Implementation
• Definitions
Subpart B – Electronic Records
• Controls for closed systems
• Controls for open systems
• Signature manifestations
• Signature/record linking
Subpart C – Electronic Signatures
• General requirements
• Electronic signatures and controls
• Controls for identification codes/passwords
5. 1. limiting system access to authorized individuals
2. Use of operational system checks
3. Use of authority checks
4. Use of device checks
5. Determination that persons who develop, maintain, or use
electronic systems have the education, training, and
experience to perform their assigned tasks
6. Establishment of and adherence to written policies that hold
individuals accountable for actions initiated under their
electronic signatures
7. Appropriate controls over systems documentation
8. Controls for open systems corresponding to controls for
closed systems bulleted above
6. 1. Access Management
2. User Management System and Privileges
3. Electronic Data
4. Audit Trial
5. Electronic Signature
6. System and Data Backup
7. "Part 11, Electronic Records; Electronic
Signatures — Scope and Application". U.S
Food & Drug Administration. U.S Food &
Drug Administration. Retrieved 15
September 2016