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

• June 10, 2026
• 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

• June 17, 2026
• 3 Hours
• US$299.00
• 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

• June 26, 2026
• 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

• July 1, 2026
• 90 Minutes
• US$149.00
• 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

• July 7, 2026
• 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

• July 14, 2026
• 90 Minutes
• US$149.00
• Enroll

It will also consider the European Union's MDR Technical Documentation requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

John E Lincoln

• July 21, 2026
• 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

• July 27, 2026
• 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 28, 2026
• 90 Minutes
• US$149.00
• Enroll

The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety/effectiveness, or when a series of lesser changes finally reach the "tipping point".

John E Lincoln

• July 31, 2026
• 90 Minutes
• US$149.00
• Enroll