ISPE CEUs: 1.3
Type: Classroom Training Course
This course has been updated to include the recently announced FDA Part 11 Inspection Assignments!
EU regulatory expectations as reflected in the draft revised Annex 11 will also be explored.
This course is also available online. Complying with Part 11 – Risk Management.
Using the GAMP® Good Practice Guide: A Risk Based Approach to Compliant Electronic Records and Signatures as a resource, this course will give participants a practical introduction to the 21 CFR Part 11 regulation, which affects all aspects of computerized systems in the pharmaceutical industry and up-to-the-minute information on the status of FDA's current re-examination of the regulation, including a discussion of the Agency's latest Part 11-related guidance and inspection assignments. Taught through classroom presentations, workshop sessions, and team exercises, the course will present an overview of Part 11 including its objectives, benefits, and potential problems. This will be followed by a detailed analysis of Part 11 requirements, a discussion of electronic records and signatures, and key industry issues.
A central element of this course will be an explanation of the GAMP approach to 21 CFR Part 11 compliance, as well as compliance with other international regulations covering electronic records and signatures. The GAMP Guide provides timely and much needed direction on meeting current regulatory expectations for compliant electronic records and signatures. The Guide describes how a risk management approach may be used to ensure the compliance of regulated electronic records and signatures, through the application of appropriate controls commensurate with the impact of records and the risks to those records.
Immediately apply the course objectives using the complimentary copy of the GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures.
This training course is of particular interest to existing and future members of the ISPE GAMP Community of Practice (COP).
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This course can be offered at your company site in its current format or customized to meet the needs of your organization.