Verification and validation requirements have always been part of the US FDA's GMPs. Yet companies still struggle with the performance of and documentation of Equipmnet, Process, Software, and quality management system validations.

John E Lincoln

• June 25, 2025
• 3 Hours
• US$299.00
• Enroll

The US FDA has announced steps toward a new regulatory policy and framework specifically tailored to promote the development of safe and effective drugs using advanced artificial intelligence / machine learning algorithms by the regulated industry.

John E Lincoln

• July 1, 2025
• 90 Minutes
• US$149.00
• Enroll

This webinar will discuss the Q-Submission program, with includes Pre-Subs, Submission Issue Requests (SIRS), Study Risk Determinations, Informational Meetings, PMA 100-Day Meetings, and other meetings and uses for Q-Sub requests.

John E Lincoln

• July 15, 2025
• 90 Minutes
• US$149.00
• Enroll

ISO 9001 is an internatioinal standard for Quality Management Systems for all business or industrial systems, and is used as such by companies worldwide.

John E Lincoln

• July 18, 2025
• 90 Minutes
• US$149.00
• Enroll

This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning and Techniques with ChatGPT / AI assistance for new product development, regulatory compliance audit responses, proof of "progress against plan", and other activities requiring a planned documented rationale.

John E Lincoln

• July 22, 2025
• 90 Minutes
• US$149.00
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This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product changes and when to file a new 510(k).

John E Lincoln

• July 28, 2025
• 90 Minutes
• US$149.00
• Enroll