Executing Mock Audits and Preparing for Regulatory Inspections - Half-day Class

Better preparation for regulatory audits is essential when developing a compliance mindset throughout the organization. One method to better prepare for inspections is to perform 'mock audits' before the authorities arrive. Attendees will learn specific techniques to help identify areas of improvement before the formal inspection occurs. Attendees will also learn techniques that will enhance their effectiveness during the audit execution.

Topics Covered:
1. Compliance Mindset
- Built-in vs. tested in
2. Types of Regulatory Audits
- FDA
- ISO
- EPA
- OSHA
- Others
3. How do I prepare?
- Purpose
- Type and scope
- Logistics
- Resources
- Audit authority (internal and external)
- Team members
- Requirements
- Identifying areas of improvement
4. What documents do I prepare?
- Audit checklists
- Guidelines
- Log sheets
- Sample plans
5. Employee Conduct
- Answering questions
- Willingness to participate
- Candor
- Separating the employee from the process
6. Roles
- Auditee
- Auditor
- Client (if applicable)

Class Activities:
Attendees will role-play, switching roles among auditee, auditor and client