Education Session

503 - Dispelling the Part 11 Myths

11 November 08.15-11.15
ISPE CEUs: 0.25

Get Agenda Tracks: InformationRegulatoryQuality

Sponsored by the ISPE GAMP Community of Practice (COP)

As part of its cGMPs for the 21st Century initiative, the FDA re-examined 21 CFR Part 11 (electronic records and signatures) as a result of concern that interpretations (by the Agency and industry) could lead to unnecessary controls and costs, thus discouraging innovation and technological advances without providing added benefit to public health. Subsequently published FDA Guidance on Part 11 Scope and Application clearly describe the current FDA interpretation and inspection approach, and present a pragmatic and risk-based approach to Part 11 compliance. Myths and misunderstandings still abound in the industry. Unnecessary costs and impractical measures are still common, and the benefits of innovation and technological advances are not being fully gained.

This session aims to dispel common myths and fears, and give companies the confidence to move forward with practical and effective electronic record and signature approaches. Case studies of effective and efficient Part 11 compliance will be shared. The course leader was a member of the team that wrote the FDA Guidance on Part 11 Scope and Application.

How you will Benefit

At the end of this session, participants will be able to:

  • Understand the real requirements for Part 11 compliance
  • Avoid common pitfalls and unnecessary costs
  • Achieve effective and efficient compliance for electronic records and signatures

Who Should Attend

Computer validation practitioners, quality assurance and quality control management, regulatory compliance and regulatory affairs personnel, information technology and information systems analysts, systems engineers, and maintenance engineers

ISPE Communities of Practice (COPs)

C&Q, GAMP, and PM

View the ISPE Community of Practice (COP) Guide

Session Leader

  • Sion Wyn, Director, Conformity Ltd. United Kingdom

Session Presenter

Annual Meeting Sponsors