Compliance Training Panel

Sign In


   Forgotten your password?

Sign Up For Free!

I subscribe for news letter and updates.

By clicking Sign Up, you agree to our Terms and conditions and that you have read our Privacy Policy.





Compliance Training Panel.

Compliance Training Panel provides Quality trainings through their world class platform which enables the clients to discuss with industry experts and to gain related information.

Compliance Training Panel has been established by professionals in the field of Quality, Compliance Auditing and Health Care, Education & Finance with an objective to create an ecosystem that will deliver quality training's on compliance of various regulatory and legal requirements.

We are a US based organization specializing in online trainings in the form of Webinars and Seminars.


21 CFR Part 11 Conformance for Medical Devices
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 :
  • Origin of the regulation and changes in interpretation
  • Electronic records
  • Electronic signatures
  • Data security
  • Open, closed and hybrid systems
  • Validation methods
  • Risk analysis
Who Will Benefit:
  • Engineering personnel
  • QA
  • Management
  • IT
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.
   My Page
   How to buy
   Subscribe
   Unsubscribe
   Who we are?
   Contact us
   FAQs
Follow us on social media to get unique and exclusive deals and discounts
G+
Copyright © 2016 ComplianceTrainingPanel. All rights reserved.
Online Payments