How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach 2015 is a conference that covers topics such as:
- How to proactively assess quality system readiness for FDA inspection
- Background about FDA inspection program
- How to proactively mitigate before, during and after the inspection
- How to identify compliance risks
- Toolkit on how to assess a quality system’s readiness, and identify and mitigate potential compliance risks
- How to respond to 483s and warning letters including templates based on industry best practices
- A strategy template on how to manage a FDA inspection (front room, back room, role playing, dos and don’ts, etc.)
- A checklist of information that should be prepared prior to inspection
- Toolkit on how to prepare responses to 483 observations and warning letters
How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach 2015 brings together:
- Managers
- Quality Engineers
- VPs, Regulatory Affairs
- Directors
- Risk Managers
- Auditors
- Management Representatives
- Compliance Officers
- Members of Senior Management Team
- Management with Executive Responsibilities
- Validation Managers
