This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.

John E Lincoln

• October 6, 2025
• 90 Minutes
• US$149.00
• Enroll

This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.

John E Lincoln

• October 13, 2025
• 90 Minutes
• US$149.00
• Enroll

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

• October 13, 2025
• 90 Minutes
• US$149.00
• Enroll

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

• October 15, 2025
• 3 Hours
• US$299.00
• Enroll

The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called "locked" algorithms that don't continually adapt or learn every time the algorithm is used.

John E Lincoln

• October 24, 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

• October 28, 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

• October 31, 2025
• 90 Minutes
• US$149.00
• 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

• November 3, 2025
• 90 Minutes
• US$149.00
• Enroll

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

• November 7, 2025
• 90 Minutes
• US$149.00
• Enroll

This webinar will examine the existing requiements for theUS FDA's DHF - including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.

John E Lincoln

• November 14, 2025
• 90 Minutes
• US$149.00
• Enroll

Verification and validation requirements have always been part of the US FDA's GMPs.

John E Lincoln

• November 19, 2025
• 3 Hours
• US$299.00
• Enroll