Understanding and Preparing for System Based Inspections: Comprehensive Training Package (6 Courses)

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.

The entire course is designed to 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 Pre-Approval Inspection.

Part 1:

Understanding and Preparing for System Based Inspections: The Quality System

Areas Covered in the Webinar:

• 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.

Part 2:

Understanding and Preparing for System Based Inspections: Facilities and Equipment System

Areas Covered in the Webinar:

• 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 Facilities and Equipment System covered during the webinar.

Part 3:

Understanding and Preparing for System Based Inspections: Materials System

Areas Covered in the Webinar:

• 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 Materials System covered during the webinar.
• Examples of what the inspection will address during the review of the Materials System covered during the webinar.
• Case studies for observations found on the Materials System covered during the webinar.

Part 4:

Understanding and Preparing for System Based Inspections: Production System

Areas Covered in the Webinar:

• 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 Production System covered during the webinar.
• Examples of what the inspection will address during the review of the Production System covered during the webinar.
• Case studies for observations found on the Production System covered during the webinar.

Part 5:

Understanding and Preparing for System Based Inspections: Packaging and Labeling System

Areas Covered in the Webinar:

• 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 Packaging and Labeling System covered during the webinar.Examples of what the inspection will address during the review of the Packaging and Labeling System covered during the webinar.
• Case studies for observations found on the Packaging and Labeling System covered during the webinar.

Part 6:

Understanding and Preparing for System Based Inspections: Laboratory Control System

Areas Covered in the Webinar:

• 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.
• 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

Panelist Profiles:
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.