21 CFR part 11 Compliance - Electronic Records & Electronic Signatures



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 should you attend this webinar?

 

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 can Benefit:

 

  • Engineering personnel
  • QA
  • IT
  • Management

Speaker and Presenter Information

Edwin Waldbusser

Ed is Keynote Speaker at ComplianceKey. He is 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. QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/ control and manufacturing. He now consults internationally in the area of quality systems for medical devices with emphasis on design control, software validation, risk analysis and human factors analysis. 

Relevant Government Agencies

Electronic Records & Electronic Signatures


    Event Type
    Webcast


    This event has no exhibitor/sponsor opportunities


    When
    Tue, Feb 18, 2020, 3:30pm - 4:30pm ET


    Website
    Click here to visit event website


    Organizer
    Compliance Key


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