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Electronic Records- Webinar Recording (November 28, 2012)

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Electronic Records: What it means to be 21CFR part 11 compliant
Organized by the North American LRA Committee

Date:  November 28th, 2012

Time:  12:00PM ET to 1:00PM ET

Speakers: Karen Nichols, Esq. RAC, VP Regulatory and Quality, OvaScience, Inc. USA and Bill Janssen, PhD. Director, Cell Therapies Facility, H. Lee Moffitt Cancer Center, USA

About the webinar:

Overview of 21 CFR Part 11

  • Basic rule
  • Key concepts from preamble

Learning Objective: basic understanding of the rule and its background - value of using preambles generally to understand FDA regulations

Defining predicate rules and e-sign

  • Literal examples from 21 CFR (such as 21 CFR 211.182)
  • Practical examples (requirement to have batch records)

Learning Objective: an understanding of what predicate rules are, where to find them, how they drive Part 11 implementation

Creating and Executing a Part 11 Compliance Plan

  • Enterprise systems vs. local systems

Learning Objective: identifying steps and tools for putting a compliance plan in place

Case Studies

  • Learning Mgt. System
  • ERP System
  • EDMS

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