Surviving an FDA Inspection: Understand the Do`s and Don`ts and the Ground Rules 2015

Topics

• 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

Who should Attend

Attendees from regulated companies that are preparing for FDA inspections, including:

• QA/QC/Compliance/Regulatory Affairs
• All levels of Management for all departments
• Engineering/Technical Services/Validation
• Information Technology/Marketing & Sales
• Operations and Manufacturing
• Consultants