This six part webinar for System Based Inspections 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.
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.
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.
Why should you Attend:
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..
There are 6 parts to a Systems based inspection; Quality System, Facilities and Equipment System, Materials System, Production System, Packaging and Labeling System, and Laboratory System. Each of the 6 presentations in this series will be a standalone webinar but will focus on one of the 6 systems. This six part webinar series 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.
Areas Covered in the seminar:
All the 6 sessions will cover the areas mentioned below with reference to one system in one module;
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 specific system covered during the webinar.
Examples of what the inspection will address during the review of the specific system covered during the webinar.
Case studies for observations found on the specific 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.
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. Bob has managed project teams that included engineering and design, construction, equipment procurements, installation, commissioning, and validation..
In a recent project, he was responsible for the start-up of a new Aseptic processing division encompassing a three building campus. Processes were being transferred from Europe, Australia, Japan and US facilities to a newly designed facility that Bob was accountable for in the US. In this role, he was responsible for all aspects of quality as well as interfacing with regulatory agencies. A natural leader and mentor, he presents courses as well as contributes to industry publications. In his role as a leader, Bob recruited, trained and developed his staff to maintain the required expertise to support the industry.