Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections

Why Should you Attend:

It is inevitable, that every FDA regulated firm, at some time will be inspected by the FDA. But are you ready?

To be adequately prepared, a firm must be proactive and strategically prepare for a FDA or other Regulatory audits to assure a successful outcome. In addition to a mock FDA audit, preparation needed for the implementation of an effective Standard Operating Procedure (SOP) for managing FDA Investigators and other regulatory auditors when on-site. This procedure will document the firm's audit policies and describes "how to" best practices procedures so that your staff is prepare for outside auditors. Implementing these procedures will assure that key personnel are properly trained and prepared, and may have significant influence on the outcome of the audit. Without these procedures, your firm may be placing itself at risk to additional and unnecessary FDA and other Regulatory Investigator scrutiny.

In this SOP best practices course, you will understand the key policies and procedures that must be included in your SOP and how to properly manage FDA investigations for the best outcome. After the course, you will be able to either critically review your current SOP, if you have one, or this course will definitely help you and your staff to develop a "state of the art" SOP.

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

Instructor Profile:

Glen Feye, M.S., CQE is the President of Accurate FDA Consultants a full service consulting firm that specializes in regulatory and clinical affairs, quality systems, training solutions and compliance for the FDA regulated industry. Mr. Feye is a senior Regulatory Affairs and Quality Assurance professional with first-hand experiences with interaction with the FDA in the medical device, IVD, biologics, and pharmaceutical industries. He has helped numerous clients prepare for successful FDA Inspections, a s well as respond properly to FDA-483. In addition, Mr. Feye has helped clients resolve over 20 Warning Letter cases.

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