Speaker Profile


Edwin Waldbusser

Regulatory Consultant, Med Device Advisors, Founder, Medical Device SOP Advisors,LLC-offering 82 SOP's

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson Reuters Expert Witness network.

  •  Monday, September 10, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 90 Minutes
  • ¤150.00
21 CFR Part 11 - Compliance for Electronic Records and Signatures

This webinar details the regulation and how it applies to computerized systems.

  •  Tuesday, October 2, 2018
  • 10:00 AM PDT | 01:00 PM EDT,
  • 60 Minutes
  • ¤150.00
Medical Device Hazard Analysis Following ISO 14971

The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools.

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  • Recorded
  • View Anytime
  • ¤190.00
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 will be explained.

  • Recorded
  • View Anytime
  • ¤190.00
Software Validation for the New FDA Inspections

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

  • Recorded
  • View Anytime
  • 75 Minutes
  • ¤190.00
21 CFR Part 11 - Compliance for Electronic Records and Signatures

This webinar details the regulation and how it applies to computerized systems.

  • Recorded
  • View Anytime
  • ¤190.00
Software Validation for the New FDA Inspections

This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.

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NetZealous LLC,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

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