How to Prepare for and Host a FDA Inspection and Respond to 483's
WebcastFaculty
OVERVIEW
How to Prepare for and Host a FDA Inspection and Respond to 483's is organized by Compliance4All and would be held on Aug 8, 2017.
The target audience for this medical event for Engineering Personnel, Engineering Management, Quality Management, Corporate Management, Manufacturing Management, Division Management.
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.
Why should you Attend :
FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
Areas Covered in the Session :
• Personnel Preparation
• Facility Needed to Support Inspection
• Behavior During Inspection-what not to Sign
• Internal/ Mock Audits
• 483 Response
Additional details will be posted as soon as they are available.
The target audience for this medical event for Engineering Personnel, Engineering Management, Quality Management, Corporate Management, Manufacturing Management, Division Management.
In this webinar you will learn about the types of FDA inspections, preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection ( front room, back room), the value of mock audits, how personnel should conduct themselves, the inspection process and how to respond to 483s and warning letters.
Why should you Attend :
FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483's than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.
Areas Covered in the Session :
• Personnel Preparation
• Facility Needed to Support Inspection
• Behavior During Inspection-what not to Sign
• Internal/ Mock Audits
• 483 Response
Additional details will be posted as soon as they are available.
SPECIALITIES
Quality ManagementQuick Links