Expectations for meaningful hazard analysis, hazardous conditions, use errors and corrections, design conterol of new and changed product, and documentation have always existed by regulatory agencies.

John E Lincoln

• July 27, 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 Artificial Intelligence Act establishes a regulatory and legal framework for AI within the EU. It covers most AI systems, with exemptions for AI used only for military, national security, research purposes, or for non-professional use. The Act classifies AI applications by their risk of causing harm.

John E Lincoln

• July 29, 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 31, 2026
• 90 Minutes
• US$149.00
• Enroll

The artificial intelligence technologies granted FDA marketing authorization and cleared by the Agencyhave mostly been "locked" algorithms that don’t continually adapt or learn every time the algorithm is used.

John E Lincoln

• August 5, 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

• August 5, 2026
• 90 Minutes
• US$149.00
• Enroll

This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new product development under Design Control, ISO 13485 7.3. Product AI requirements, abd using AI to assist in Design Control documentation will also be discussed.

John E Lincoln

• August 10, 2026
• 90 Minutes
• US$149.00
• Enroll

The artificial intelligence technologies granted FDA marketing authorization and cleared by the Agency are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used.

John E Lincoln

• August 17, 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

• August 17, 2026
• 90 Minutes
• US$149.00
• Enroll

This webinar will examine the existing and new EU and AI requirements for Technical Documentation - including derivative documents, the DMF and Lot Records (DHR).

John E Lincoln

• August 19, 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

• August 24, 2026
• 3 Hours
• US$299.00
• Enroll

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.

John E Lincoln

• August 24, 2026
• 90 Minutes
• US$149.00
• Enroll

Software and related hardware design, development, verification and validation is difficult to manage, document and control, and especially so with AI implementations.

John E Lincoln

• August 31, 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

• September 2, 2026
• 90 Minutes
• US$149.00
• Enroll