Assuring Your Supply Chain through Supplier Qualification Training Course :

<strong>Course Schedule - Pre-recorded Course</strong><br/><br/>This 90-minute <b><i>accredited</b></i> online training will discuss important elements of a sound supplier qualification program. Discussions will focus on the considerations in selecting a supplier and the techniques for assessing the supplier's quality system. Special attention will be directed toward the evaluation of supplier product quality, supply chain concerns, and notification of change. This presentation will include the latest thinking by the FDA on this matter.<br><br> <b><u>Module 1:</u><br> Supplier Selection</b><br>   • Criteria<br>     – Business relationship<br>     – Regulatory considerations<br>     – Technical expertise<br>   • Quality System requirements<br>     – ISO 9001 Certification<br>     – Food GMP<br>     – Excipient GMP<br>   • Quality System Assessment Techniques<br>     – Questionnaire<br>     – Second Party Audit<br>     – Third Party Audit<br><br> <b><u>Module 2:</u><br> Auditing the Supplier</b><br>   • Audit Standards<br>     – ISO 9001<br>     – Food GMP<br>     – Excipient GMP<br>   • Assessment Organizations<br>     – ISO registrars<br>     – GMA Safe and AIBN<br>     – USP Certified and IPEA<br><br> <b><u>Module 3:</u><br> Evaluation of Supplier Product Quality</b><br>   • Requesting evaluation samples<br>   • Process capability and Validation<br>   • Lot Selection<br> <b>Notification of Change</b><br>   • Importance of notification<br>   • Evaluation of changes<br> <b>Supply Chain issues</b><br>   • Purchasing from a Distributor<br>     – Distributor operations<br>     – Distributor Quality System Requirements<br>   • Identifying the manufacturer<br>     – Establishing Pedigree<br><br> <b>Question and Answer Session</b><br>