cGMP Auditing - Strategies for 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
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
- Quality Control
- Regulatory Compliance
- Packaging
- Documentation control
- Purchasing
- Engineering
- Production
- Laboratory
- 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
Attend this course and its companion course, Preparing for and Surviving an FDA Inspection, ID# 187 (Offering # 0808-306) and save $300 off combined regular tuition.