The Center for Professional Advancement, New Brunswick, NJ
August 15, 2007
Who Should Attend:
Newly assigned auditors or those who expect to be involved in auditing in the near future, will find this course beneficial. Those individuals who expect their departments, groups or functions to be audited will also find the program of great interest. The material in this course can be helpful to professionals in a variety of functions, such as:Quality Assurance
Laboratory
Quality Control
Production
Regulatory Compliance
Engineering
Packaging
Purchasing
Documentation control
Vendors/suppliers
Description:
This practical, introductory course was designed to provide a mechanism for those interested in understanding the basic requirements for auditing in the pharmaceutical and related industries. The course presents an introduction to the evolutionary process of FDA regulations and describes in detail the latest FDA initiatives in the inspection process. It provides a road map for auditors in setting up a cGMP audit trail from beginning to end. Specific compliance aspects like change control, outsourcing, and validation will be presented as they pertain to the audit function. The course will consist of lectures, interactive discussions and a hands-on workshop.
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