Description:
This course covers the requirements of the US FDA cGMP standards and is based upon ISO 19011-2018 Guidelines for Quality and/or Environmental Management Systems Auditing Participants are taught how to plan, conduct, and report the results of a Quality Management System Audit.
The course contains ten (10) practical exercises which students complete both individually and in a team environment to gain auditing competence.
Topics Include:
- Reviewing the requirements of the cGMP’s
- Process Auditing
- Audit Planning
- Audit Execution
- Audit Reporting
- Nonconformances (including types)
- Corrective Action (including verification)
Who Should Attend?
Those individuals within your organization who will be conducting internal QMS audits and who meet the personal attributes stated in ISO 19011.
Prerequisites:
No prior knowledge of US FDA cGMP’s is required. However, students are encouraged to read the cGMP standard prior to attending the course.
Duration:
3 Days (24 Hours)
Participants who receive a 70% or better in both the course exercises and the live audit will receive a Certificate of Completion.
Type: On-Site Training
Price: $7500 (for up to 15 people) plus course materials and travel for the instructor