GAMP Data Integrity 21 CFR Part 11 Training Course

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.

Recorded Version Only

(PPT + Recorded Streaming Link)

1x Person - Unlimited viewing for 6 Months (For multiple locations contact Customer Care)
rec Recorded Link and Ref. material will be available in My Account Section
Last Recorded Date: May-2023

Download File Only

(PPT + Recorded Training File)

Downloadable file is for usage in one location only.
(For multiple locations contact Customer Care)
Downloadable link along with the materials will be emailed within 2 business days
Customer Care

Fax: +1-650-362-2367


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Why Should You Attend:

The importance and amount of data being generated to ensure product quality and patient safety continues 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.

Areas Covered in the Webinar:

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 as an important tool in ensuring data integrity
  • How to apply the new ISPE GAMPĀ® 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:
  • All those working in a GxP regulated environment that require a working knowledge of data integrity, electronic records and signatures, and the associated operational aspects of GxP computerized systems.
  • Anyone who needs a fundamental understanding of the 21 CFR Part 11 regulation and risk management approaches to achieving electronic record and signature compliance.
  • Computer system vendors or consultants, engineering contractors, and validation service companies.
  • Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations.
Instructor Profile:
Kelly Thomas Kelly Thomas

Vice President, Americas Quality Operations at Stallergenes Greer

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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-771-6965 (Toll Free).

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