Description
Designed to introduce participants to the US FDA cGMP standards. This course provides an overview of the requirements of the standard, including required documentation and processes.
Background & Concepts
- What do Current Good Manufacturing Practices mean?
- Where did these standards come from?
- The third-party audit concept
- Process Approach to a Quality Management System
Understanding the Requirements
- The requirements and sections of the standard
- How to address the requirements at your organization
- How to build an cGMP conforming quality management system
- The steps taken to achieve registration
The Internal cGMP Auditing Process
- Training auditors and developing an internal audit program
- Surviving an FDA Audit
- Time and resource allocation
- Next steps
Who Should Attend?
Executive officers of your organization, managers, process owners, supervisors, and quality assurance personnel who want to understand the requirements of US FDA cGMP’s, what is needed for an effective quality management system, and how to prepare for cGMP compliance.
Prerequisites: No prior knowledge of the US FDA cGMP’s is required.
Duration: 4 – 6 hours
Type: On-Site Training
Price: $2500 (for up to 15 people)