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Data Integrity 21 CFR Part 11 Training

  • Training Type Recorded Webinar
  • Presenter Kelly Thomas
  • Topic Pharmaceutical
  • Schedule Jun 26, 2023
  • Timing 1:00 PM EDT
  • Duration 90 minutes
Registration Options
Recording $229
Recording & Transcript $399
Transcript $229
DVD $299
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Description

The importance and amount of data being generated to ensure product quality and patient safety continue to grow, and proper controls around that data continue to be a subject of regulatory scrutiny. Regulatory agencies across the world are repeatedly citing data integrity issues. As a result, industry guidance and enforcement strategies are evolving. Regulatory concerns and warning letters have extended to all areas of the pharmaceutical, biotech, and medical device business, including manufacturing, development, clinical, pharmacovigilance, and other areas of the product lifecycle. This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle. This training course will provide a practical understanding of the following:

  • The current regulatory focus on Data Integrity, including a detailed discussion of US 21 CFR 11
  • Relevant regulatory observations
  • Current regulatory Guidance on Data Integrity (emphasizing MHRA and FDA)
  • The need for Data integrity throughout the system and data life cycles
  • Detailed examination of the data life cycle
  • The requirement for a data governance framework
  • A data integrity maturity model
  • How to meet the international regulatory requirements for electronic records and signatures
  • Detailed examination of specific requirements of 21 CFR 11 electronic records and signatures
  • How to satisfy Part 11, including interpretation of the FDA Scope and Application Guidance
  • How to meet the requirements of other relevant regulations including EU Annex 11
  • How to apply the current industry risk-based good practice approach to compliant electronic records and signatures

How to maintain Data Integrity through the GAMP system life cycle and beyond

  • How cloud computing approaches can impact data integrity
  • Data integrity and mobile apps
  • Data mapping is an important tool for ensuring data integrity
  • How to apply the new ISPE GAMP® Guide: Records and Data Integrity including:
    • Data Governance Framework
    • Culture and Human Factors
    • Data Life Cycle
  • Applying Quality Risk Management to Data Integrity

Areas Covered:-

  • This training course will provide a practical understanding of the following:
  • The current regulatory focus on Data Integrity, including a detailed discussion of US 21 CFR 11
  • Relevant regulatory observations
  • Current regulatory Guidance on Data Integrity (emphasizing MHRA and FDA)
  • The need for Data integrity throughout the system and data life cycles
  • Detailed examination of the data life cycle
  • The requirement for a data governance framework
  • A data integrity maturity model
  • How to meet the international regulatory requirements for electronic records and signatures
  • Detailed examination of specific requirements of 21 CFR 11 electronic records and signatures
  • How to satisfy Part 11, including interpretation of the FDA Scope and Application Guidance
  • How to meet the requirements of other relevant regulations including EU Annex 11
  • How to apply the current industry risk-based good practice approach to compliant electronic records and signatures
  • How to maintain Data Integrity through the GAMP system life cycle and beyond
  • How cloud computing approaches can impact data integrity
  • Data integrity and mobile apps
  • Data mapping is an important tool for ensuring data integrity
  • How to apply the new ISPE GAMP® Guide: Records and Data Integrity including:
  • Data Governance Framework
  • Culture and Human Factors
  • Data Life Cycle
  • Applying Quality Risk Management to Data Integrity

Who Will Benefit:-

  • Analytical Development
  • Quality Assurance
  • Quality Control
  • Validation
  • Regulatory Affairs
Registration Options
Recording $229
Recording & Transcript $399
Transcript $229
DVD $299
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Access Information for Live Session will be emailed to you 12 hours prior the live date.

Access Information for On-Demand, and Transcript will be emailed to you 24 hours post of the live session.

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Speaker
Kelly Thomas

Kelly Thomas

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes, and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.


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