Conducting Effective Quality Audits
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This overview course is designed for those who have
recently been involved, or expect to be involved in internal
or external audits.
The program will benefit individuals in the pharmaceutical
and related industries, such as medical device, diagnostics,
cosmetics, food, biotechnology as well as vendors, suppliers
and contract organizations.
The course can be of interest to top management responsible
for audit programs in their companies as well as to
professionals in a variety of functions such as:
• QA & QC
• Laboratory
• R & D
• Production
• Regulatory
• Toxicology
• Documentation Management
• Clinical Research
• Packaging
• Purchasing
Description
Auditing is a powerful management tool in establishing how
effectively a company controls the quality of its products and
ensures compliance.
This hands-on, practical course will deal primarily with auditing
tools and techniques which are applicable to any industry or
function. A quick overview of requirements for an audit
program in pre-clinical and clinical operations will be provided.
Specific examples will cover auditing certain aspects of drug
and medical device operations for compliance with cGMP.
The course will consist of lectures, discussions, exercises,
workshops and a role-playing session involving a simulated
compliance audit.