Auditing for GMP Compliance
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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.