This FDA inspection training compiles the best practices now being used by many companies to host FDA inspections that will satisfy FDA inspectors and result in a good experience for the company. FDA inspections require a large amount of preparation and knowledge. Are you informed enough to avoid Warning Letters
FDA on-site inspections can be cause for a great deal of worry for drug, biologics and device companies, and with good reason. If an inspection does not go well, the FDA will start out by demanding changes in the company’s practices with a Form 483, and continue by issuing a warning letter if these demands are not met. Many companies spend long hours preparing for inspections with mock inspections. However, it can be difficult to know exactly what to expect.
This FDA Inspection training brings a large amount of information together in one place to give you somewhere to start. It will show you tried and true methods for satisfying FDA inspectors, with tips for the interview process, behavior during an inspection, and how to manage an inspection’s outcome. Targeted at company management, QA, and personnel with little or no experience in FDA inspections, this training will guide you through the daunting task of preparing for an FDA inspection.
FDA on-site inspections can be cause for a great deal of worry for drug, biologics and device companies, and with good reason. If an inspection does not go well, the FDA will start out by demanding changes in the company’s practices with a Form 483, and continue by issuing a warning letter if these demands are not met. Many companies spend long hours preparing for inspections with mock inspections. However, it can be difficult to know exactly what to expect.
This FDA Inspection training brings a large amount of information together in one place to give you somewhere to start. It will show you tried and true methods for satisfying FDA inspectors, with tips for the interview process, behavior during an inspection, and how to manage an inspection’s outcome. Targeted at company management, QA, and personnel with little or no experience in FDA inspections, this training will guide you through the daunting task of preparing for an FDA inspection.
Areas Covered in the seminar:
- The latest updates on FDA inspections and trends.
- The various types of inspections.
- The Inspection Process.
- The best ways to ensure a smooth inspection.
- Roles and Responsibilities.
- Recommendations for the Closeout Meeting.
- What to do after the inspection team leaves.
Who Will Benefit:
This webinar targets company management, QA, and personnel with little or no experience in FDA inspections. This webinar provides information to help make inspections less of a stressful event, but rather a powerful learning experience for future activities. Companies, contract facilities, and university laboratories will benefit from the information presented in this webinar, specifically:- Company management
- University study management
- Study personnel
- QA representatives
- Legal departments
Course Provider
Anne E Maczulak,
