Loading Purplepass...
|
Talent
Edwin Waldbusser Description
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.
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. FDA requirements for 21CFR Part 11 validation will be explained. the requirements are composed of technical and procedural aspects. open, closed and hybrid (paper and electronic) systems will be explained. Why ? Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483’s at their next inspection. Part of this fear originates from confusion. FDA originally published a rather severe 21 CFR Part 11. After industry complaints the FDA acknowledged that the regulation, as written, would result in nobody attempting to convert to electronic records. But, instead of rewriting the regulation, FDA said it would “selectively enforce” sections of the regulation. This webinar will explain what all this means. A 21CFR checklist and a Test protocol form will be given as handouts. Areas Covered in the Session :
Who Will Benefit:
About Speaker: Edwin Waldbusser retired from industry after 20 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. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing/ non-conforming product programs. Edwin Waldbusser 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. Event URL: https://www.compliancetrainingpanel.com/Webinar/Topic?WB=MD00103
Organizer: Compliance Training Panel Website: www.compliancetrainingpanel.com/Webinar/Live Phone: 844-216-5230 Email: support@compliancetrainingpanel.com |
Presented By
1:00pm to 2:00pm
General Admission: $229.00
21+
200 844-216-5230 UPCOMING EVENTS
PAST EVENTS
Tuesday, June 26th
Online Event Past Event
Thursday, June 14th
Online Event Past Event
|
