Understanding and Preparing for FDA's New Part 11 Inspection Program - Webinar By GCPanel

Nov. 29, 2010 - PRLog -- Overview: Within the next few weeks and months the FDA will conduct a series of Part 11 related inspections.

Planned routine inspections will be extended to evaluate the companies' practices to ensure accuracy, integrity, authenticity and availability of electronic records, and the FDA plans additional 'for cause inspections'. Inspections are planned for US but also in foreign countries. The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry.

Reference material for easy implementation:

   * 25 recent FDA Warning Letters with part 11 violations.
   * 15 Case Studies: Implementing Part 11
   * Validation templates and examples

Areas Covered In the Seminar:

   * FDA inspections: Preparation, conducts, follow up
   * Learning from past Part 11 inspections
   * Scope of the new Part 11 program: time frame, expected outcome
   * Criteria for selection of target companies
   * What inspectors are looking for
   * How to prepare your company for the upcoming inspections
   * Learning from previous inspections with focus on Part 11 and computer validation: most frequently cited deviations
   * How to fill gaps short term
   * Developing a program for long term
   * Creating the right documentation to satisfy the inspectors
   * Most likely next steps after the inspection program

Who will benefit:

   * IT managers and system administrators
   * QA managers and personnel
   * QC and Lab managers
   * Validation specialists
   * Regulatory affairs
   * Training departments
   * Documentation department
   * Consultants

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