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61 results
On-Demand Webinar
Supervising a Human Error Free Environment: You can do a Lot More than you think
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Intermediate
- 90 Mins
- Ginette Collazo
On-Demand Webinar
Performance of Root Cause Analysis, CAPA, and Effectiveness Checks
This comprehensive course offers essential knowledge and practical skills in root cause analysis, corrective and preventive actions (CAPA), and conducting effectiveness checks. Participants will learn systematic approaches to identify root causes, develop effe ...
- Intermediate & Advan
- 90 Mins
- Meredith Crabtr
On-Demand Webinar
The FDA Inspection from SOP to 483
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 ...
- Intermediate
- 90 Mins
- Jose Mora
On-Demand Webinar
Data Governance for Computer Systems Regulated by FDA
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDL ...
- Basic & Intermediate
- 60 Mins
- Carolyn Troiano
On-Demand Webinar
21 CFR Part 11 - Compliance for Electronic Records and Signatures
This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA-regulated companies, and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse
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
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
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