Mr.John E. Lincoln

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information. Due to the growth of the cybersecurity threat to electroni ...

The US FDA, a has published their QMSR 21 CFR 820, to replace the previous QSR 21 CFR 820, Medical Devices, implemented February 02, 2016. They also released their new Device Inspection Manual 7382.850, on the same date, with the focus on Patient / User Risk M ...

Regulated CGMP companies must develop / implement a formal CSA, Computer Software Assurance program, addressing AI where appropriate, per the FDA's recent Guidance Document. Software and related hardware design, development, verification and validation is dif ...

The FDA's DHF, DMR, DHR, and the EU's MDR TF/DD - Meeting their different purposes; future trends. This webinar will examine the existing requirements for the US  FDA's DHF -- including its derivative documents, the DMR and DHR, and the identical ISO 13485 7. ...

How to develop, modify and use the tools of the User/Patient Device Risk Management File per ISO 14971:2019 (a major requirement of the new QMSR), Pharma's ICH Q9, and Error Reduction with IEC 62366-1, Useability Engineering, with added HEP considerations. Ex ...

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 ...

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 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 ...

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 ...