FDA's 21 CFR Part 11 Add-On Inspections
Navigate FDA's increased scrutiny of electronic records and software validation — implement effective 21 CFR Part 11 V&V strategies aligned with GAMP, ISO 14971, and real-world inspection expectations.
Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
What You'll Learn
About the event
About this event
The verification and validation of cGMP software is coming under increased scrutiny by the U.S. FDA. This webinar addresses the use of U.S. FDA Guidance, GAMP, 21 CFR Part 11, Electronic Records/Signatures, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Risk Management models and their real-world implementation.
The FDA has eliminated its "selective enforcement" policy and is now looking for proper implementation of the control of electronic records and electronic signatures. Regulatory auditors are increasingly comfortable delving into software issues. This webinar provides simple but effective real-world 21 CFR Part 11 software V&V strategies in today's resource-constrained environment.
Code: FDB2787
Curriculum
Requirements
- Senior and middle management, R&D, Engineering, Software, QA/RA, Manufacturing, and Operations
- Applicable to companies in Medical Devices, Diagnostic, Pharmaceutical, and Biologics fields
Meet Your Instructor
John E. Lincoln
FDA Regulatory Affairs, Design Control & QMS Expert
John E. Lincoln has over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new/changed product 510(k)s, process/product/equipment including QMS and software validations, ISO 14971 product risk management files/reports, Design Control/Design History Files, and Technical Files. He has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). John has prior experience in military, government, electronics, and aerospace industries. He is a peer-reviewed author, teacher, and speaker, and a graduate of UCLA.
Event Details
Format
Recorded Webinar
Duration
1.5 hours
Certificate
Included
Access
Lifetime
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