This system based inspection for Laboratory Control System training/webinar includes measures and activities related to laboratory procedures, testing, analytical methods development and validation or verification, and the stability program.
This system includes measures and activities related to laboratory procedures, testing, analytical methods development and validation or verification, and the stability program.
A primary mission of the FDA is to conduct comprehensive regulatory inspections covering all aspects of production and distribution of drugs for sale in the US. Due to the ever increasing number of drug applications as well as manufacturers that wish to sell their products in the US, the FDA inspection resources were stretched too thin to ensure appropriate inspections on a biennial basis (every two years) as required. In 2001 a pilot program was launched to change the focus from profile classes (types of drugs produced) to a systems based inspection. The expectation being that the various systems covered multiple profile classes, and this would speed up the review process while ensuring compliance.
Why Should You Attend:
Development and launch of a new drug product is a time consuming and expensive undertaking. Countless man-hours and multiple millions of dollars are invested in design, construction, equipment, commissioning, validation, and testing. To protect your investment, preparation for the Pre-Approval Inspection (PAI) must be a key part of any drug launch strategy. This webinar will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI.This system includes measures and activities related to laboratory procedures, testing, analytical methods development and validation or verification, and the stability program.
A primary mission of the FDA is to conduct comprehensive regulatory inspections covering all aspects of production and distribution of drugs for sale in the US. Due to the ever increasing number of drug applications as well as manufacturers that wish to sell their products in the US, the FDA inspection resources were stretched too thin to ensure appropriate inspections on a biennial basis (every two years) as required. In 2001 a pilot program was launched to change the focus from profile classes (types of drugs produced) to a systems based inspection. The expectation being that the various systems covered multiple profile classes, and this would speed up the review process while ensuring compliance.
Areas Covered in the seminar:
- Review of the Systems Based Inspection Program.
- Preparation prior to a PAI inspection.
- How to manage a regulatory inspection.
- How to respond to regulatory inspection observations.
- Review of the elements of the Laboratory Control System covered during the webinar.
- Examples of what the inspection will address during the review of the Laboratory Control System covered during the webinar.
- Case studies for observations found on the Laboratory Control System covered during the webinar.
Who Will Benefit:
This series of webinars will be useful to employees and management who are involved in the preparations for Pre-Approval Inspections including validation, quality, regulatory, documentation control, and operations staffCourse Provider
Robert Ferer,
