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Auditing, Qualifying & Controlling, Suppliers & Contractors for Pharmaceuticals and Medical Devices
This course reviews the qualification cycle for suppliers and contractors. Although the process is similar, the contractor requires more scrutiny because contractors are subject to GMPs.
While there is very little disagreement about the importance of controlling suppliers and contractors, quality problems and compliance issues attributed to supplier/contractor failures continue to be very problematic in our industry.
Some reasons this problem exists include lack of understanding of the process and its requirements, fragmented procedures that do not consider the logic and flow of the processes as a whole, the failure to understand the interdepartmental tasks and responsibilities, and the failure to communicate the requirements to the supplier or contractor. These failures are frequently seen in FDA 43 citations and warning letters. Senior Management can see the impact on profit and customer satisfaction.
The FDA continues to place a high priority on quality failures attributed to supplier/contractor failures caused by supplier/contractor provided components and products. The root cause is a failure of the company to control the supplier and contractor. In May 2013, the FDA published the quality agreement guidance on the requirements for quality agreements. While this may clarify some compliance issues, more understanding of quality systems is required to sufficiently address these issues.
Introduction, Purpose, and Objectives
Basic Regulatory and ICH/IMDRF (Was GHTF) Requirements for Suppliers and Contractors-
FDA Guidance 5/24/2013-Contract Manufacturing Arrangements for Drugs: Quality Agreements
The structure of your supplier and contractor is impacted by your organizational structure
The brick-and-mortar company
The combination brick-and-mortar and virtual company
The totally virtual company
Organizing and Establishing the Supplier/Contractor Qualification and Control Program
Roles and Responsibilities
The Entire Supplier and Contractor process will be flowcharted and visually describing the flow beginning with the developmental specification to through the commercial process.
Determining criticality of the specification and or requirements to determine approval strategy
Qualifying the supplier’s samples and associated test methods if applicable
Determining the qualification requirements-
Selecting the audit team and audit preparation
Conducting the audit and evaluating the audit results
Writing and sending the report and handling the supplier response
Follow-Up and monitoring
Qualifying for reduced testing
Disqualifying the supplier
The Changing Supplier/Contractor Paradigm and the Future
Why Should you Attend:
Whatever your experience level is, this webinar will help you understand the entire lifecycle of suppliers and contractors. They gaining an understanding of the processes, you can compare your processes to the processes described in this webinar. You’ll see the strengths and weaknesses of your own processes so that you may build on the strengths and improve the weaknesses. The result will be a more effective operation.
Objectives of the Presentation:
To clearly define the regulatory requirements for incoming material controls and suppliers/contractors.
To introduce quality concepts and principles outside the regulations that improves supplier/contractor control and effectiveness
To provide a perspective on the FDA guidance “Contract Manufacturing Arrangements for Drugs: Quality Agreements”, May-2013
To enhance the understanding of the supplier-contractor lifecycle by using flowcharts describing the logical inputs and outputs of the process
To describe the “What & How” for establishing a program for effectively controlling suppliers and contractors
Who can Benefit:
For those whose include responsibilities and tasks related to materials, materials testing, and working with suppliers and contractors, this webinar will provide new perspectives and suggestions for improving your existing program.
For those new to these task and responsibilities, you’ll begin to understand the processes and their requirements and see a logical flow of relationships between elements so that you can begin to make immediate contributions to the organization.
For others, it will broaden your understanding of the material and supplier/contractor quality systems so that you may explore new areas of quality and develop your professional skills and abilities.
Nihar Ranjan Mohanty