Preparing Subject Matter Experts for a Regulatory Audit
ObjectivesTo prepare subject matter experts for a regulatory audit.
Content includesBy the end of the workshop attendees will:
- Understand the context of the pending regulatory audit
- Appreciate audit methods that may be used (focus on the FDA’s Quality System Inspection Technique)
- Consider current hot topics / 483’S / Warning Letters etc...
- Consider how to explain an overview of their process clearly
- Practice being interviewed on a part of their process
- Receive feedback on their performance, focusing on their audit behaviour
Who should attendProcess owners, subject matter experts and supervisors who may be audited directly.
No training dates available at the moment.