This FDA Inspection training 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 (Pre-Approval Inspection).
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 assures overall compliance with cGMPs and internal procedures and specifications. The system includes the quality control unit and all of its review and approval duties (e.g., change control, reprocessing, batch release, annual record review, validation protocols, and reports, etc.). It includes all product defect evaluations and evaluation of returned and salvaged drug products. 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 Facilities and Equipment System covered during the webinar.
- Examples of what the inspection will address during the review of the Facilities and Equipment System covered during the webinar.
- Case studies for observations found on the quality 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 staff
Instructor Profile:
Robert Ferer, is President and founder of The Ferer Group Inc. A graduate of the State University of New York at Stony Brook, Bob is an engineering chemist and has more than 19 years direct industry experience including the design, build, start-up, and management of facilities, specializing in aseptic manufacturing. His expertise ranges from developing and executing project master plans, schedules, and budgets to performing hands-on validation, design review, and equipment start up and commissioning. A natural leader and mentor, he presents courses as well as contributes to industry publications.
To further develop his awareness of the pharmaceutical and biotechnology industries’ advancements, Bob is an active member of the International Society of Pharmaceutical Engineers and the Parenteral Drug Association. Bob frequently managed large projects and was instrumental in providing high-level consultation to clients. This included due diligence, facility audits, PAT implementations, and technology transfer. In his role as a leader, Bob recruited, trained and developed his staff to maintain the required expertise to support the industry.
