Mr.John E. Lincoln

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 ...

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 ...

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 ...

3D/ AM printing can create many types of medical devices from metals, plastics, hydrogels, and even biological materials.New terms, materials usage / application, unique device construction, all raise new metrics and quality concerns.The US FDA recognizes this ...