Achieving and Maintaining 21 CFR Part 11 Compliance

$595.00

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Description

This 1-day seminar reviews the requirements, FDA guidance and industry positions on the Electronic Records & Electronic Signatures rule. The seminar addresses enabling technologies and mechanisms to ensure that the system remains compliant throughout its lifetime. Participants learn how to:

  • Evaluate new and existing systems for compliance
  • Complete a Gap Analysis
  • Prepare a Remediation Plan
  • The Registration Fee includes attendance, continental breakfast, lunch, and breaks, and an attendee binder containing slides, handouts, and activities.

Additional information

Dates Offered:

May 01, 2017 Feasterville, PA, November 06, 2017 Feasterville, PA

AM

  • Introduction
    • Agenda & session goals
    • History & Rationale of the Rule
    • Other Regulatory Initiatives
  • 21 CFR Part 11 Rule Content
  • Cryptography & Digital Signature Concepts
  • Part 11 Compliance Process
    • Process Introduction
    • System Inventory
PM

  • Part 11 Compliance Process (continued)
    • GAP Analysis Exercise
    • Remediation Planning
      • Options
      • Enabling Technologies
  • Staying Current
    • 483s & Warning Letters
    • Industry & Agency Actions
    • Resources
  • Wrap-up