Best Practices for FDA Inspection 2016 is a seminar that covers topics such as:
- Ways to train employees in view of the inspection
- How a firm should prepare for an FDA inspection
- 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
Best Practices for FDA Inspection 2016 brings together attendees from:
- QA/QC/Compliance/Regulatory Affairs
- All levels of Management for all departments
- Engineering/Technical Services/Validation
- Information Technology/Marketing & Sales
- Operations and Manufacturing
- Consultants
