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Validity : 24th Aug'25 to 03rd Sep'25
Search Trainings
Live Webinar
Employer and Payroll Updates due to OBBBA 2025
On July 4th 2025 President Trump signed in the One Big Beautiful Bill Act into law. This legislation is sweeping legislation that impacts all aspects of the United States. However, there are major impacts coming to employers and payroll departments across the ...
- Basic & Intermediate
- 60 Mins
- Dayna J. Reum
- Sep 22, 2025
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
Medical Device Software Verification and Validation Following FDA 2024 Guidance and ISO 62304
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation and how to use ISO62304 to establ ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
On-Demand Webinar
Public Speaking without Fear: How to Go from Nervous to Natural and Turn Panic into Poise
Whether in an informal setting or a more formal presentation, we all want to bring our “A Game” any time we speak up in a meeting or express our ideas. Plan to join us if: Quite frankly, you hate public speaking You’ve been embarrassed because you get shak ...
- Basic & Intermediate
- 60 Mins
- Mandi Stanley
Recorded 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 regulations and guidance for years, however, AI/ML programs fall outside the scope of these regulatio ...
- Basic & Intermediate
- 60 Mins
- Edwin Waldbusse
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
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
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
Recorded Webinar
Medical Device Software Validation Meeting FDA Regulations
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are us ...
- Basic & Advanced
- 60 Mins
- Edwin Waldbusse