Mr.John E. Lincoln

This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Desig ...

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 t ...

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 ...

This webinar will define what are the US FDA's expectations for proper laboratory / clinical / manufacturing practices, systems, equipment usage, and documentation / record-keeping. It will evaluate the requirements for how  basic Quality Management System (QM ...

This webinar will provide valuable guidance to regulated companies in development and implementation of Project Management Planning concepts including some common chatbot / AI tools (and their risks), Lean / Agile principles, for new product development, Desig ...

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 ...

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 ...

Due to the growth of electronic records and electronic signatures in CGMP documentation, as well as computer-controlled manufacturing, and medical devices, the US FDA has issued a draft Guidance for Industry, outlining its expectations for increased data integ ...

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 ...