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
Who should Attend
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
Past Events
How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach 2015 - 22-23 Oct 2015, Philadelphia, Pennsylvania, United States (53631)
Important
Please, check "How to Prepare for, Manage, and Follow-up to an FDA Inspection: Risk-driven Approach" official website for possible changes, before making any traveling arrangements
