This SOP best practices webinar will show how to create state of the art SOP or review your current SOP so as to successfully manage FDA Investigators and other Regulatory Authorities Audits which can help improve and influence Audit Outcomes.
Areas Covered in the Seminar:
- Prepare a proactive SOP for Managing a FDA Inspection.
- Identify clearly roles and responsibilities.
- Define inspectional policies.
- Identify key ground rules.
- Define the Conduct of the Inspection.
- Handling Introduction -FDA 482.
- Handling Sampling Request -FDA 484.
- Handling the End of Inspection -FDA 483.
Who Will Benefit:This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Executive Managers faced with future FDA Inspections
- Personnel with Direct FDA Contact
- Regulatory, Compliance, QA Managers and Personnel
- Subject Matter Experts that will interact with FDA
