Edwin Waldbusser
regulatory consultant
Ed retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. He was involved in the development of products such as IVD devices, kidney dialysis systems and inhalation devices. His QS experience includes, design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/non-conforming product programs. He now consults in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.
Upcoming Webinar
Live Sessions Not Found.
Recorded Webinar
21 CFR Part 11 - Electronic Record and Signature Validation
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.FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.
Recorded Session Get life time access for one participant with download option!

Computer System Validation
According to the FDA requirements all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Computer system validation is more than testing. It is testing plus design control and configuration management.
Recorded Session Get life time access for one participant with download option!

How to Prepare for and Host a FDA Inspection and Avoid 483's
In this webinar you will learn about the types of FDA inspections, necessary preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection, the value of mock audits, how company personnel should conduct themselves during the inspection, how the inspection will unfold and how to respond to 483's.
Recorded Session Get life time access for one participant with download option!

21 CFR Part 11 - Electronic Record and Signature Validation
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.FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both. The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained.
Recorded Session Get life time access for one participant with download option!

Human Factors Usability Studies Following ISO 62366 and FDA Guidance
This training program will examine how 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 effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.
Recorded Session Get life time access for one participant with download option!

Qualification of Contract Manufacturer Organizations Based on Practical Experience
This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs). It will teach best practices to meet regulatory requirements and satisfy practical needs to obtain the best CMO.
Recorded Session Get life time access for one participant with download option!

How to Prepare for and Host a FDA Inspection and Avoid 483's
In this webinar you will learn about the types of FDA inspections, necessary preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection, the value of mock audits, how company personnel should conduct themselves during the inspection, how the inspection will unfold and how to respond to 483's.
Recorded Session Get life time access for one participant with download option!

Medical Device Complaints & CAPA
This webinar will explain the CAPA process from information gathering through MDR and Recall decision making to final CAPA closing. Post closing effectiveness evaluation is required and will be explained. Preventative Action is often neglected and will be discussed. Post distribution product monitoring including customer surveys will be explained. Integration of manufacturing non conformities with the CAPA program will be discussed.
Recorded Session Get life time access for one participant with download option!

Qualification of Contract Manufacturer Organizations Based on Practical Experience
This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs). It will teach best practices to meet regulatory requirements and satisfy practical needs to obtain the best CMO.
Recorded Session Get life time access for one participant with download option!

Mobile Medical Apps (Is It a FDA Regulated Device?) and Cybersecurity
With mobile platforms more user friendly, and with computers, tablets and smart phones becoming more powerful, we see an increase in the offering of apps. Some of these apps are specifically targeted to assist individuals in the management of their health and wellness, while other apps are targeted to healthcare providers as tools to assist in the delivery of care.
Recorded Session Get life time access for one participant with download option!

Medical Device - Engineering Change Control
This webinar can help you control your engineering change process, reduce your change order cycle times and eliminate ambiguity when communicating product changes to your extended supply chain.
Recorded Session Get life time access for one participant with download option!

Medical Device Reporting Requirements for Manufacturers Final Guidance
This webinar explains the MDR regulation considering the new information contained in the Guidance and describes a compliant MDR procedure. Areas covered will include death, injury and mal-function reporting requirements, record keeping requirements, report timing, clarification of the term ‘becoming aware’ and clarification of reporting using electronic form 3500A.
Recorded Session Get life time access for one participant with download option!

Medical Device Premarket and Post market Cyber security following the new FDA Guidances
Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. This vulnerability increases as medical devices are increasingly connected to the Internet, hospital networks and to other medical devices. This webinar will describe a program that will minimize risk to the user from cyber attacks.
Recorded Session Get life time access for one participant with download option!

How to Conduct a Human Factors Validation Test Following ISO62366 and the FDA Guidance
Validation testing aims to show that a device can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions. This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation test. HF/U validation is very different from device validation. For example, success criteria are 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.
Recorded Session Get life time access for one participant with download option!

21 CFR Part 11 - Electronic Record and Signature Validation
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.FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient.
Recorded Session Get life time access for one participant with download option!

Conducting a Software Validation of Medical Device to Meet FDA Requirements
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 Session Get life time access for one participant with download option!

Hazard Analysis following ISO 14971
FDA expects that as part of a product development program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is the most powerful of the risk management tools described in ISO 14971 but it is very confusing. Many new concepts are introduced. We will explain these concepts and provide examples so that the process is clear.
Recorded Session Get life time access for one participant with download option!

How to prepare for and Host FDA Inspection and Avoid 483's
In this webinar you will learn about the types of FDA inspections, necessary preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection, the value of mock audits, how company personnel should conduct themselves during the inspection, how the inspection will unfold and how to respond to 483's.
Recorded Session Get life time access for one participant with download option!

Risk Based Approach for Medical Device Design Control
This course will explain how to manage a Design Control program that will meet FDA requirements and minimize chances of your medical device being recalled. Such a program will also help to get projects completed on time and within budget. The important and confusing question of when, in a development process, Design Control begins will be answered. The difference between pre-release and post release change control will be explained.
Recorded Session Get life time access for one participant with download option!

Human Factors/Usability Based on ISO 62366
This training program will examine how 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 effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.
Recorded Session Get life time access for one participant with download option!

21 CFR Part 11 - Electronic Record and signature Validation
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 Session Get life time access for one participant with download option!

SUBSCRIBE TO NEWSLETTER
Get industry updates and exclusive deals on offers!