Mr.John E. Lincoln

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 ...

This webinar provides guidance regarding  Good Laboratory Practice, Good Clinical Practice and God Manufacturing Practices for use in pharmaceutical manufacturing and clinical trials, and for use by contract laboratories that support the regulated medical prod ...

This 3-hour seminar is focused on the workings of the Quality Management System, what is required of a compliant  system according to ISO 9001, and the QMS audit.  This seminar will  evaluate the requirements for the foundational / basic Quality Management Sys ...

This webinar will examine the existing requiements for the US  FDA's DHF -- including its derivitive documents, the DMR and DHR, and the identical ISO 13485 7.3 D&DF.  It will consider the EU's recently revised MDR and it's Technical Documentation File require ...

This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA' s two Guidances, "510(k) Device Modifications:  Deciding When to Submit a 510( ...

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 ...