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Course ID:
1881

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Auditing for GMP Compliance

This course is not currently scheduled. Click on the Notify Me button to the left to be notified when it is scheduled.

This course is available as a client site course. Please click here for more information.

Who Should Attend
This overview, practical course is designed for those auditors who have recently been involved or expect to be involved in internal or external GMP audits.

The program will benefit individuals in the pharmaceutical, medical device and related industries like diagnostics, cosmetics, food, biotechnology as well as vendors, suppliers and contract organizations.

The course can be of interest to top management responsible for GMP audit programs in their companies as well as to professionals in a variety of functions such as:

  • QA/QC
  • Laboratories
  • R& D
  • Production
  • Regulatory Compliance
  • Packaging
  • Engineering
  • Documentation Management

Description
GMP regulations worldwide as well as FDA and ICH guidances require that companies have in place an internal quality audit program. Auditing is also a powerful management tool in establishing how effectively a company controls the quality of its products and ensures compliance.

The program will deal primarily with auditing tools and techniques needed when conducting effective internal and external GMP audits.

This practical course will consist of lectures, interactive discussions and hands-on workshops including a role playing session.

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Strategies for Setting up and Implementing Supplier Audits
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Strategies for Setting up and Implementing Supplier Audits
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Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
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