Mr.John E. Lincoln

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). Consideration of the U.S. FDA's two current guidance docu ...

Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. There is an increased awareness of the importance of design activities to support the production of safe and effective product. Pro ...

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. However, the FDA is looking beyond th ...

Verification and validation requirements have always been part of the US FDA’s cGMPs.  However, with increasing technology, both industry, and regulatory agencies' expectations have increased.  Recent high-profile field problems indicate that V&V activities ar ...

What are the basics of an enterprise maintenance-focused Quality Management System? This webinar will examine that question by means of the international standard, ISO 9001, the international standard for Quality Management Systems for all business or industri ...

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when new products are to be marketed in the U.S., or when existing products and/or their Indic ...

In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested fi ...

“All software, firmware, ladder logic, must be validated” – US FDA. Verification and validation requirements have always been part of the US FDA’s GMPs. Where does 21 CFR Part 11 fit in? Pt 11 “selective enforcement”? “Add on”? Companies still struggle with th ...

The verification and validation of medical industry software are coming under increased scrutiny by the U.S. FDA. This webinar will address the use of the FDA, GAMP®, 21 CFR 11, and other applicable industry software validation models, coupled with the ISO 14 ...

This project management training for FDA-regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for the successful development and implementation of pro ...