ISPE CEUs: 1.3
Type: Classroom Training Course
|This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.|
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.
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).
ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.