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.
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.
Agenda
- 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
