Course offering number:1003-707
Course ID:
2396
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PAI: Surviving the Pre-Approval Inspection
In Conjunction with Wiley-Blackwell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This online training course is intended for managers, supervisors, engineers, chemists, scientists, technicians and formulators
working within the Pharmaceutical, and related industries. It will also be valuable to documentation specialists, auditors and
those in regulatory affairs. Personnel from the following departments will find the course beneficial:
• Research and Development
• Quality Assurance and Control
• Manufacturing/Operations
• Facilities
• Finance
• IT
• Audit
• Training
• Technical Support
This training will also benefit suppliers of equipment and services to the medical device industry.
Description
The Pre-Approval Inspection (PAI) is the last major regulatory hurdle prior to a product launch. It is essential that the
manufacturing site satisfy FDA expectations during and in follow up to the PAI. This 90-minute accredited training draws on
experiences from over a dozen PAI's since 2006 and discusses pragmatic, simple strategies for PAI preparations, conduct
and follow up.
Module 1:
• What is a PAI?
• Preparing for the PAI
• Assigning tasks to various departments and rehearsing
Module 2:
• What systems are likely to be
covered and how is this
typically done?
• Risk Analysis...A good tool for
predicting what course the
investigation will take
• What Documentation should we
have at the "War Room"?
• How to interface with the FDA during
the Investigation
Module 3:
• The Wrap-up meeting. Discussing
the 483
• How to address observations
• Common mistakes to avoid
Question and Answer Session