Who Should Attend
This overview course is designed for those who haverecently 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
• Materials 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.