Speaker Profile

Edwin
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.

Upcoming Webinars Recorded Webinars
  • 5
  • December
  • 2019
  • Thursday
10:00 AM PST | 01:00 PM EST

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.

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
  • 8
  • January
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
  • 22
  • January
  • 2020
  • Wednesday
10:00 AM PST | 01:00 PM EST

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.

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
  • 11
  • February
  • 2020
  • Tuesday
10:00 AM PST | 01:00 PM EST

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 the FDA Guidance will be explained.

Edwin Waldbusser Edwin Waldbusser | Duration:60 Minutes | Price: $150.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 75 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host a FDA Inspection and Respond to 483's

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Prepare for and Host a FDA Inspection and Respond to 483's

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

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 used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

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 used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Price: $190.00 | View Details
Edwin Waldbusser

Medical Device Software Validation

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.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

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 the FDA Guidance will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

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 the FDA Guidance will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

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 the FDA Guidance will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $190.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 75 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

How to Prepare for and Host a FDA Inspection and Respond to 483's

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

How to Prepare for and Host a FDA Inspection and Respond to 483's

In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

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 used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

21 CFR Part 11 - Compliance for Electronic Records and Signatures

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

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

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 used in validation will be described.

Speaker: Edwin Waldbusser | View Anytime | Price: $390.00 | View Details
Edwin Waldbusser

Medical Device Software Validation

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.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

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 the FDA Guidance will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 90 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

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 the FDA Guidance will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

How to Conduct a Human Factors - Usability Validation Test following ISO 62366 and the 2016 FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/usability validation.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

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.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details
Edwin Waldbusser

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 the FDA Guidance will be explained.

Speaker: Edwin Waldbusser | View Anytime | Duration: 60 Minutes | Price: $390.00 | View Details