21 CFR Part 11 Conformances for Medical Devices

Live Webinar

  • 60 minutes
  • 8 Days Left
     Aug 12, 2020
  •   01:00 PM - 02:00 PM ET
    10:00 AM - 11:00 AM PT

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 this entire means, A 21 CFR checklist, 32 Validation protocol templates, and a SOP will be given as handouts.

Join this session with expert speaker Edwin Waldbusser, where he will explain the confusion over the original FDA regulation and its subsequent “selective enforcement”. FDA requirements for 21 CFR Part 11 validation, the requirements are composed of technical and procedural aspects, Open, closed and hybrid (paper and electronic) systems and he will also talk on Data security and electronic records.

Session Highlights:

This webinar will cover the following topics.

  •  Origin of the regulation and changes in Interpretation

  •  Electronic records

  •  Electronic signatures

  •  Data security

  •  Open, closed and hybrid systems

  •  Validation methods

  •  Risk analysis

Why You Should Attend:

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.

Attendees will receive a multipage outline and checklist.

Who Should Attend:

  •  Engineering personnel

  •  QA

  •  IT

  •  Management

You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Edwin Waldbusser

Edwin Waldbusser

Ed retired from industry after 27 years in management of development of medical device products and development of company Quality Systems.  He has been a consultant for the last 9 years, working with companies from startups to Fortune 100 in the US, Germany, United Kingdom,Netherlands, Canada, Poland and Saudi Arabia. He specializes in design control, risk analysis, human factors, software validation, and supplier qualification/ control.

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.

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