Part 11 - Electronic Records and Electronic Signatures

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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