Mr.Jose Mora

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and g ...

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria are qualitative rather than quanti ...

This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including wh ...

An external auditor is coming to your plant.  Their first impression may have a major impact on your plant's future as well as your own career.  How will your plant look to that auditor? Before they even set foot in the door - what your grounds and outside fa ...

Project Management involves not only the management of tasks and task owners, but also of information involving documents, records, and many other elements. The traditional approach is to compile, create and push these through the various stages. The concept ...

In today's rapidly evolving regulatory landscape, organizations across industries are under increasing pressure to ensure compliance with a multitude of laws, regulations, and industry standards. Compliance audits play a vital role in assessing an organization ...

The Theory of Lean Documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries.   Just as lean principles challenge traditional process concepts and "push ...

An OSHA inspection provides a view into your organization’s safety culture. This training will share a step-by-step guide on how to strategically prepare for a safety audit before it happens, which includes newly defined rules that employers need to know. Addi ...

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.  Medical device manufacturing plants, required to follow 21 CFR ...

In this Lean Documents, Lean Configuration, and Document Control training learn the different types of lean documents and the usage of lean document principles; types of controlled documents; examples of lean and non-lean controlled documents. Pros and cons of ...