Purchase any WEBINAR and get
10% Off
CODE: SAVE10
T&C applicable, please referFAQ
Validity : 07th Sep'25 to 17th Sep'25
Search Trainings
166 results
Recorded Webinar
How to Write SOPs for Human Error Reduction
Human error is the primary cause of quality and production losses in many industries. Although human error is unlikely to ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
On-Demand Webinar
Unraveling Mistakes: A Comprehensive Course on Human Error Investigation
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Person ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
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Human Factors/ Usability Studies following ISO62366, the FDA Guidance, and the new FDA Draft Guidance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
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 software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and g ...
- Basic & Intermediate
- 60 Mins
- Jose Mora
Recorded Webinar
The FDA and Cosmetic Oversight- What does that look like?
"The FDA and Cosmetic Oversight - What does that look like?" is a training session aimed at providing participants with an understanding of the role of the Food and Drug Administration (FDA) in regulating cosmetics. The training covers various aspects, includi ...
- Intermediate & Advan
- 90 Mins
- Meredith Crabtr