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.

Register your interest

Course

Preparing Subject Matter Experts for a Regulatory Audit

Training Days

0.5 day

Training Location

Available nationally, based on demand

Course Cost

IMDA Skillnet Member: €75
* Cost quoted per person

Register your interest