FDA’s 21 CFR Part 11 Add-on Inspections Recorded Webinar | John E Lincoln | From: May 06, 2021 - To: Dec 31, 2021 |
Medical device software has become integral and indispensable in the controlling, running, and monitoring of medical product processes, whether in the pharmaceuticals, medical device, biologics, or dietary supplements industries. 21 CFR Part 11 addresses all electronic records; hence many of these applications that feed into cGMP data acquisition and records come under its purview. Foraging through the Internet forums will show three is much confusion on the subject. 21 CFR Part 11 is increasingly being used for e-records and e-signatures and in company-wide ERP (Enterprise Resource Planning) systems. Regulatory auditors are more comfortable with delving into software issues. Real-world software V&V is increasingly more important in today’s resource-constrained industrial environment to ensure that it fulfills its intended purpose. The verification and validation of medical device software are coming under increased scrutiny by the U.S. FDA, and especially any software involved in cGMP compliance. Our presenter John Lincoln will guide you through the use of the FDA guidance documents, GAMP, 21 CFR 11, and other applicable industry software validation models. This coupled with the ISO 14971 / ICH Q9 Risk Management models as well as their real-world implementation will be addressed in this webinar. This session will also discuss and explain how to establish an effective software documentation model which is compliant and field-tested (FDA and Notified Body) as per 21 CFR Part 11 guidance. This discussion will focus on a preferred U.S. FDA documentation “model” in various applications, including ERP, in-device, as-device, process/equipment control, wherever cGMP data/records are gathered, utilized, stored, and retrieved.
Areas Covered in the Session:-
Who Should Attend:-
This webinar will provide valuable assistance to all the personnel/companies in the Medical Devices, Diagnostic, and to a lesser extent the Pharmaceutical and Biologics fields. The employees who will benefit include:
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
