Achieving and Maintaining 21 CFR Part 11 Compliance

Seminar Agenda

AM

v         Introduction

            –    Agenda & session goals

            –    History & Rationale of the Rule

            –    Other Regulatory Initiatives

v                 21 CFR Part 11 Rule Content

v                 Cryptography & Digital Signature Concepts

v         Part 11 Compliance Process

–        Process Introduction

–        System Inventory

PM

v         Part 11 Compliance Process (continued)

–        GAP Analysis Exercise

–        Remediation Planning

–        Options

–        Enabling Technologies

v         Staying Current

–        483s & Warning Letters

–        Industry & Agency Actions

            –    Resources

v                 Wrap-up

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