Part 11 - Electronic Records and Electronic Signatures

Instructor: Betty Jones
Product ID: 700619
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2007

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

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Read Frequently Asked Questions

This Part 11 - Electronic Records webinar will provide an insider’s view FDA’s current thinking regarding the scope and application of Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11).

It will provide guidance in fulfilling requirements in the statute and parts of FDA’s regulations for maintaining records or submitting designated information electronically.

Areas Covered in the seminar:

  • Scope and Application
  • FDA’s Part 11 Approach
    • Validation
    • Audit Trail
    • Legacy Systems
    • Record Copies
    • Record Retention
    • Enforcement

Who Will Benefit:

This webinar will provide valuable assistance to pharmaceutical, device and biologics regulated companies in or transitioning into a cGMP compliant environment. It is also useful as a refresher for companies that wish to stay current with FDA's expectations for records maintenance and submission. The employees who will benefit include:

  • Management
  • Information Technology Managers
  • Quality Units
  • Auditors
  • Quality Systems Personnel
  • Consultants

Instructor Profile:

Betty Jones, MPH, is Founder/Managing Director of Comprehensive Compliance Solutions (CCS), a consulting firm specializing in all aspects of regulatory compliance and training to firms that manufacture and market FDA regulated products. Ms. Jones, the former Deputy Director of the Office of Compliance, CDER is a recognized expert in applying and interpreting FDA's statutes, codes, regulations and standards. She has over 33 years of experience with the FDA directing regulatory and compliance activities in three of FDA's six components and has experience as a field investigator/inspector, a compliance officer, Branch Chief and Acting Director of the Office of Compliance in the Center for Drug Evaluation and Research.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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