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 are ...

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 requirem ...

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 ...

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 ...

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 ...

This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF -- including its derivitive documents, the DMR and DHR.It will consider the European Union's MDD TF/DD requirements currently being phased out and the new EU MDR Technical ...

Review a company's Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Starting with a Master Validation Plan, evaluating i ...

CAPA and the related tools of Failure Investigation and Root Cause Analysis (RCA) are major components of product complaint, non-conformance, and OOS failure investigations, and hazard analysis/risk management and mitigation activities, as well as product improvement ...

IEC has released a new medical device usability standard, IEC 62366-1:2015, “Usability Engineering in IEC 62366-1:2015 --  Part 1: Application of the new Usability Engineering Standard to Medical Devices” and “IEC/TR 62366-2:2 Part 2: Guidance on the application of u ...

This webinar will discuss the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed. Also considered: Areas re ...