An FDA inspection puts the people responsible for compliance in the spotlight. This 75-minute FDA inspection training gives medical device and pharmaceutical professionals the rationale, strategies and workflows to plan for an inspection and manage it with confidence.

You'll cover the types of inspections, how to prepare, which company roles to assign, the facility resources you need and whether to run internal audits, mock audits or both. The session explains what an inspection SOP should contain and how to behave during the inspection: what to say, what not to say and how to say it.

You'll also learn the limits of FDA's scope, including documents you don't have to show and the rules on photographs and affidavits, plus how to handle the close-out interview and respond to a Form 483.

WHY SHOULD YOU ATTEND?

Does the FDA call first or just show up? Where can the inspector go, what should they see and whom should they talk to? Planning, training and composure make the difference between a smooth inspection and a costly one.

The session helps regulated medical device, diagnostic, pharmaceutical and biologics companies, including quality auditors, compliance officers, executives, regulatory, QA, product development, engineering, manufacturing, complaint handling, training and document control staff, and people new to the industry.

AREA COVERED

• Types of inspections
• Preparing for FDA inspections
• Dedicated personnel for the inspection
• Facility resources to support the inspection
• Internal audits, mock audits or both
• Contents of an SOP for FDA inspections
• Recommended behavior during an inspection: what to say, what not to say and how to say it
• The inspection process and close-out interview
• Limits of FDA's scope, including documents you need not show, photographs and affidavits
• Best practices for responding to a Form 483
• Common questions: advance notice, where the inspector may go, tours, what to show, whom they may interview and how long they stay

LEARNING OBJECTIVES

• Identify the types of FDA inspections and how to prepare for each
• Assign inspection roles and facility resources
• Decide when to use internal and mock audits
• Write an SOP for managing FDA inspections
• Conduct yourself effectively during the inspection and close-out interview
• Explain the limits of FDA's inspection scope
• Respond to a Form 483 using best practices

WHO WILL BENEFIT?

This webinar will provide valuable assistance to all regulated companies, since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• Quality Auditors
• Compliance Officers
• Executive Management
• Managers/Directors/Supervisors and Personnel related to:

            o    Regulatory Compliance and Regulatory Affairs;
            o    Quality Management System;
            o    Quality Assurance;
            o    Product Development;
            o    Engineering;
            o    Manufacturing;

• Complaint Handling
• Personnel new to the regulated industry
• Training personnel
• Document Control Personnel