In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Edwin Waldbusser

• June 9, 2026
• 60 Minutes
• US$149.00
• Enroll

This webinar will explain the process of analyzing and minimizing cyber risks for premarket submissions.

Edwin Waldbusser

• June 10, 2026
• 60 Minutes
• US$149.00
• Enroll

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.

Edwin Waldbusser

• June 16, 2026
• 60 Minutes
• US$149.00
• Enroll

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Edwin Waldbusser

• June 23, 2026
• 60 Minutes
• US$149.00
• Enroll

This webinar will explain the procedure described in ISO 62366, the FDA Guidance, and the new draft Guidance for a compliant human factors/ usability validation.

Edwin Waldbusser

• June 24, 2026
• 60 Minutes
• US$149.00
• Enroll

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.

Edwin Waldbusser

• July 1, 2026
• 60 Minutes
• US$149.00
• Enroll

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

Edwin Waldbusser

• July 8, 2026
• 60 Minutes
• US$149.00
• Enroll

This webinar will explain the process of analyzing and minimizing cyber risks for premarket submissions.

Edwin Waldbusser

• July 15, 2026
• 60 Minutes
• US$149.00
• Enroll

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.

Edwin Waldbusser

• July 22, 2026
• 60 Minutes
• US$149.00
• Enroll

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective.

Edwin Waldbusser

• July 28, 2026
• 60 Minutes
• US$149.00
• Enroll

This webinar will explain the procedure described in ISO 62366, the FDA Guidance, and the new draft Guidance for a compliant human factors/ usability validation.

Edwin Waldbusser

• July 29, 2026
• 60 Minutes
• US$149.00
• Enroll