Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included 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.
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.
Webinars by this Keynote Speaker
How to conduct a Human Factors and Usability validation following ISO62366 and the new FDA Guidance Life Sciences , Medical DeviceFDA Compliance ,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 Read more
How to prepare for and host a FDA inspection and respond to 483’s FDA Compliance , Laboratory ComplianceFDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483 warning letter than a disorganized company. Read more
Human Factors and Usability Studies FDA Compliance , PharmaceuticalMedical Device ,Human Factors Usability is the analysis of how people interact with medical devices and medical device risk analysis. The various types and methods of human factors analysis will be explained. This Read more
21 CFR Part 11 Compliance Life Sciences , FDA ComplianceBiotechnology , Pharmaceutical , Medical Device , Drugs & Chemicals ,This Webinar will explain what 21 CFR Part 11 training is, why it is important to c companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling el Read more
Writing Ethical, Focused and Credible Internal Audit Reports
Speaker: Philip VassalloPrice: $285
Moving from an Operational Manager to a Strategic Leader
Speaker: Chris DeVanyTime: 01:00 PM EDT | 10:00 AM PDT
Location: New York
Logistics Channel Incoterms Standards
Speaker: Dr. Rossano V. GeraldTime: 01:00 PM EDT | 10:00 AM PDT
Location: New York
Thank you for the spreadsheet webinar. The webinar was informative and helpful. Although many of the concepts are known and understood by Industrial and Process Engineers, it is always helpful to have a straightforward review. The spreadsheet will be beneficial in being able to help identify areas of risk and areas that may require some attention.
Benchmark Electronics , ******** Engineer
This was a very informative session, it did help my company by raising awareness in areas we lack policies. The only thing I would suggest get added to the session is direct information relating to Accounting, ex. Taxation rules for record retention as they are some records which a company is required to keep indefinitely.
First MCO, ***** Manager
Overall I found the video conference well organized and very informative. The presenter, Ronald Adler, was certainly extremely knowledgeable and presented the subject matter in a well organized, direct and succinct manner. Afford the attendee the ability to track and record paid attendance/activity without a lot of tracking and follow up in order to gather the necessary information required to record the CPEs earned and paid for.
Dynamic Marketing Systems, VP Finance & Human Resources
As this was our first experience, we did not know what to expect. I believe the webinar was informative and to the point, and explained to us the purpose of the I-9, and how the company can be affected by an audit. It really motivated us to review our files and bring them up to date.
Young Transportation, ****Coach****
I have participated in several webinars hosted by Compliance Global on various H&S topics. They are always precise, technologically-oriented, and easy to use and partake in to further my knowledge of current Health and Safety regulations and topics.