FDA’s 21 CFR Part 11 Add-on Inspections

Medical devices software have 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 is 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 :

• 21 CFR Part 11, Electronic Records / Electronic Signatures – What it is and what it isn’t?
• The proven V&V 11-element “model” – useful for all software V&V
• Developing test cases / scripts from Part 11
• “Risk Based” – what it means in SW V&V and how it should be used
• Why Part 11 violations seldom show up directly on 483’s, but are there nonetheless
• Insights on Cloud issues and Agile issues

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:

• Senior management
• Middle management
• R&D
• Engineering
• Software
• QA / RA
• Manufacturing
• Operations
• Consultants
• cGMP instructors
• All personnel especially involved in product, process, validations, cGMP responsibilities

Course Director: JOHN E. LINCOLN  

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 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 QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.