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Validity : 24th Aug'25 to 03rd Sep'25
Search Trainings
426 results
Recorded Webinar
Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance
Human Factors/ Usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the ef ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
On-Demand Webinar
ChatGPT / AI and Project Management for FDA-Regulated Companies
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 ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
On-Demand Webinar
FDA Regulation of Artificial Intelligence/ Machine Learning
AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical device software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulation ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
Recorded Webinar
Best Practices in Preparation for an FDA Computer System Audit
FDA requires that all computer systems used to produce, manage and report on “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer syst ...
- Intermediate
- 90 Mins
- Carolyn Troiano
Recorded Webinar
The Validation Master Plan – The Unwritten Requirements
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 ...
- Basic & Intermediate
- 90 Mins
- John E. Lincoln
On-Demand Webinar
21 CFR Part 11 Electronic Records and Signatures Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
Recorded Webinar
Artificial Intelligence (AI), Machine Learning, and the FDA
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 ...
- Intermediate & Advan
- 90 Mins
- John E. Lincoln
Recorded Webinar
21 CFR Part 11 Electronic Records and Signatures Compliance for Computer Systems Regulated by FDA
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, ...
- Basic & Intermediate
- 90 Mins
- Carolyn Troiano
Recorded Webinar
Data Integrity - US FDA Requirements
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 ...
- Intermediate & Advan
- 90 Mins
- John E. Lincoln
Recorded Webinar
Recovering Wage Overpayments
Recovering wage overpayments can be a time-consuming and sometimes challenging process for professionals. State laws governing recovery of employer overpayment and adjustment of related taxes often vary from the federal rules and from state to state. Recovery ...
- Basic & Intermediate
- 90 Mins
- Patrick A. Hagg