cGMP Auditing - Strategies for Compliance
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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.
Other Courses of Interest
An Overview of Documentation Requirements in FDA Regulated Industries
AN ON-DEMAND ONLINE TRAINING FORMAT
Auditing for GMP Compliance
Mar 27 2012, Amsterdam, The Netherlands
Conducting Effective Quality Audits
Documentation Management and Control
Mar 05 2012, New Brunswick, NJ
Documentation Management and Control
Jun 07 2012, Amsterdam, The Netherlands
Introduction to cGMP System-Based Audits
AN ON-DEMAND ONLINE TRAINING FORMAT
Managing FDA Inspections: the FDA investigator cometh...are you ready?
FREE On-Demand Webinar
Preparing for and Surviving an FDA Inspection
Setting up and Implementing Vendor and Supplier Audits
FREE On-Demand Webinar
Strategies for Setting up and Implementing Supplier Audits
Mar 07 2012, New Brunswick, NJ
Strategies for Setting up and Implementing Supplier Audits
Jun 11 2012, Amsterdam, The Netherlands
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
Jun 05 2012, Amsterdam, The Netherlands
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