Building a Vendor Qualification Program for FDA Regulated Industries

This course will provide detailed explanations and examples for Building a Vendor Qualification Program for FDA Regulated Industry. With today’s pharmaceutical market, raw materials, Active Pharmaceutical Ingredients (API), Containers & Closures, inactive or excipients and other components are being sourced from all over the world. We also have Third Party Manufacturers and outside testing facilities that are part of our supply chains. Building and following a robust vendor qualification Program is essential for pharmaceutical and chemical manufacturers. We must create a procedure, which will be used to remain aware of the compliance status for all of our suppliers. Some raw material components may move from producers to brokers to the end users. In addition, there may be other shippers and wholesalers responsible for moving and holding our raw material components.

Learning Objectives:

• The laws that require supplier quality audits
• Writing robust procedures for a robust supplier quality audit program
• Who must conduct these audits
• What are the qualifications needed for conducting supplier audits
• How much experience do auditors need
• Will experienced auditors from another industry suffice for CGMP audits
• The difficulties of scheduling audits
• Required number of days for each audit
• Do we have to cover every single operation during each and every audit
• Focus on the more important audit objectives first
• We will learn how to adequately communicate our questions

Areas Covered :

• The qualifications of a supplier quality audit
• The contents of an adequate supplier quality audit
• Scheduling and planning audits
• Required length of audits
• Ensuring that all of our questions are adequately conveyed and understood by our suppliers
• How to convince the suppliers that our audits must be accepted and scheduled
• What do we do if the suppliers require us to pay a fee to audit them?
• Do we need secondary suppliers for every component we use?
• Learning how to deal with the difficulties of obtaining Travel Visas
• How to maintain good conduct and respect during audits

Who will Benefit:

• Quality Assurance and Quality Controls Managers, Supervisors and Directors
• Supply Chain Personnel
• Senior Analysts in Chemistry and Microbiology and their Supervisors and Directors
• Research & Development Directors (for new products and suppliers