How to interact with the investigator-DO`s and DON`T`s
How to ensure that required documentation is in place
How to reply to 483`s and warning letters
What companies should do when the inspection ends
Post inspection actions
Legal implications of non-compliance
The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
Why inspections are conducted and by what statutory authority
Understand and apply the do`s and don`ts and comprehend that preparation is the key to success
What is subject to FDA purview and what`s off-limits
What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key
What are the prohibited "Acts" and the enforcement categories that you need to deal with
How to respond to findings and facilitating the documentation and remediation process...and reaching final closure
The company`s Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
Define clear responsibilities, roles and goals for personnel involved in SOP development
Who should Attend
Senior attendees from:
Dietary Supplements
Nutraceutical
Food
FDA regulated Industries
Pharmaceuticals
Medical Device
Clinical
Healthcare IT
Validation
Technical Services
Engineering
Past Events
Complaint Handling and Management: From Receipt to Trending 2016 - 25-26 Jul 2016, Cape Town, South Africa (59941)
Important
Please, check "Complaint Handling and Management: From Receipt to Trending" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Healthcare, Medical device, Pharma
