21 CFR Part 11: Auditing for Part 11 Compliance

Instructor: Jasmin NUHIC
Product ID: 701613
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

This 21 CFR Part 11 training will help you in Auditing for Part 11 Compliance ,how to plan, prepare, execute and close audit, what tools can be used for a successful audit.

Why Should You Attend:
21 CFR Part 11 is FDA regulation for electronic signatures and electronic records which is applicable to all industries including medical device and pharmaceuticals. Auditors and inspectors have started focusing more and more in this area as technology plays more significant role in compliance then ever before.

Compliance with Part 11 is increasingly important and being able to audit for Part 11 compliance is not only value added to the business but it is also a sought for skill in today's world. This webinar provides great deal of information and guidance as how to be effective auditor for Part 11 compliance. Attend this Webinar to know how to plan, prepare, execute , CAPA and how to close the audit. Common audit findings and pitfalls will be discussed. Discussion will be on the common tools for successful audits.

Areas Covered in the Seminar:

  • About 21 CFR Part 11.
  • Planning audits.
  • Preparing for the audit.
  • Executing the audit.
  • CAPA and close of the audit.
  • What to expect for responses.
  • Common audit findings and Common pitfalls.
  • Tools for successful audit.

Related Technical Document:

Will provide 30+ commonly asked questions; 21 CFR Part 11 regulation; Sample internal/external audit/inspection checklist based on 21 CFR Part 11 regulation.

Who Will Benefit:

  • Quality Managers
  • Quality auditors
  • Small business owners
  • CAPA investigators
  • FDA inspectors
  • Sofwtare engineers and developers
  • Consultants

Instructor Profile:
Jasmin NUHIC, serves a major medical devices OEM as a Sr. Engineer and 21 CFR Part 11 Subject Matter Expert. He also served ASQ section as a chair for two consecutive terms, has taught quality certification exam prep course, completed numerous software validations and obtained over 25 different certifications in leadership, quality, software validations, and more. Jasmin NUHIC has conducted Webinars on this and other topics with high attendance and appreciation. More information about Jasmin NUHIC can be found by visiting his profile on LinkedIn.

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