Ensuring your Site is Ready for an FDA Inspection

An FDA inspection can be a stressful and challenging experience. This webinar will help you understand the basics of FDA inspections so you can be well prepared. We will discuss how to prepare for an inspection, what to do during an inspection as well as common mistakes to be avoided.

The FDA continues to write 483 and Warning Letters to Medical Device Companies. Although an effective Quality System should always be “inspection ready”, many companies make simple mistakes leading to costly compliance issues. This webinar will help you prepare to competently respond during an inspection. You will learn how to best present information about your Quality System in a competent and factual manner. You will learn how to prepare your Subject Matter Experts (SMEs) to respond during an inspection.

AREAS COVERED IN THE SESSION:

• General Information about Inspections
• Common mistakes
• Planning for an inspection
• Pre-inspection activities
• When the inspection is announced
• Checklists by area
• During the inspection
• After the inspection
• Guidance for a 483 response

WHO SHOULD ATTEND:

• Individuals new to Medical Device companies
• Managers in functions outside of Quality wanting to prepare their organizations for an FDA inspection
• Individuals that may be called in as subject matter experts during inspections
• Compliance Personnel who will be the key contact during an FDA Inspection

Course Director: SUSANNE MANZ

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.