Preparing for a FDA Inspection
This webinar will discuss the types of FDA audits and why they occur, the Do's and Don'ts during an FDA inspection, how to properly answer questions from an inspector, the significance of 483s and warning letters, as well as lessons learned from previous FDA inspections. Areas Covered Facilities under the watchful eye of the FDAThe 4 types of FDA inspections and why they occurFDA ExpectationsWhat to do before an inspection?What happens during an FDA inspection?What documents and records will the FDA ask to see?Proper conduct during an FDA inspectionResponding to FDA questions and request How did the inspection end? Responding to the FDA inspection report, 483's, and warning letters Cours Level - IntermediateWho Should AttendQuality Assurance PersonnelValidation PersonnelValidation ManagementManufacturing PersonnelQuality Control PersonnelQuality ManagementEngineering personnelEngineering ManagementWhy Should You Attend You should attend this webinar to learn the purpose of an FDA inspection, the types of FDA inspections and why they occur, what happens during an inspection, how to prepare for an FDA inspection, proper inspection conduct, and proper response to questions from FDA inspectors. Topic BackgroundFrom drugs to medical devices to nutraceuticals and imports, the FDA inspects all manufacturers that produce products to GxP standards for compliance.Under the Federal Food, Drug, and Cosmetic Act, the FDA is required to inspect manufacturers at least once every two years even more for companies just getting started, those with a history of compliance problems, and those who have started producing products significantly different from what they produced before.
Single
This webinar will discuss the types of FDA audits and why they occur, the Do's and Don'ts during an FDA inspection, how to properly answer questions from an inspector, the significance of 483s and warning letters, as well as lessons learned from previous FDA inspections.
Areas Covered
- Facilities under the watchful eye of the FDA
- The 4 types of FDA inspections and why they occur
- FDA Expectations
- What to do before an inspection?
- What happens during an FDA inspection?
- What documents and records will the FDA ask to see?
- Proper conduct during an FDA inspection
- Responding to FDA questions and request
- How did the inspection end?
- Responding to the FDA inspection report, 483's, and warning letters
Cours Level - Intermediate
Who Should Attend
- Quality Assurance Personnel
- Validation Personnel
- Validation Management
- Manufacturing Personnel
- Quality Control Personnel
- Quality Management
- Engineering personnel
- Engineering Management
Why Should You Attend
You should attend this webinar to learn the purpose of an FDA inspection, the types of FDA inspections and why they occur, what happens during an inspection, how to prepare for an FDA inspection, proper inspection conduct, and proper response to questions from FDA inspectors.
Topic Background
From drugs to medical devices to nutraceuticals and imports, the FDA inspects all manufacturers that produce products to GxP standards for compliance.
Under the Federal Food, Drug, and Cosmetic Act, the FDA is required to inspect manufacturers at least once every two years even more for companies just getting started, those with a history of compliance problems, and those who have started producing products significantly different from what they produced before.