Topic : 21 CFR part 11 Compliance – Electronic Records & Electronic Signatures

Register : https://www.compliancekey.us/webinarDetails?industryId=3&webinarid=1583&speakerid=48&source=SUT_LN

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Overview

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.

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

Speaker Profile :

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.

Contact Info :

Compliance Key

https://www.compliancekey.us/

Email : support@compliancekey.us

Phone : +1 717-208-8666

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