Quality Training

Preparing Subject Matter Experts for a Regulatory Audit

Objectives

To prepare subject matter experts for a regulatory audit.

Content includes

By 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 attend

Process owners, subject matter experts and supervisors who may be audited directly.

Upcoming dates:

No training dates available at the moment.