Part 1 – Review Supplier Management Regulatory Guidance
Part 2 – Elements of a Robust Supplier Management Program
Part 3 – Review of Risk Analysis Tools and Recent Audit Observations
Regulatory expectations are clear about manufactures’ responsibility regarding supplier quality oversight.All regulatory agencies agree that pharmaceutical and medical device manufactures are responsible for ensuring their suppliers adhere to quality standards, maintain compliance with regulatory requirements and consistently meet established expectations. Therefore, it is essential pharmaceutical and medical device organizations develop and implements a robust supplier management program.
A robust program is one that utilizes a comprehensive life-cycle approach that manages suppliers from initial qualification through phase-out.In other words, from cradle to grave. A robust, yet efficient, supplier management program is one that also utilizes risk-based methodology to determine supplier criticality and the required level of oversight
This course will review regulatory guidance governing Suppliers; as well as, all the elements of a robust supplier management program; including, initial qualification, supplier performance monitoring, and scorecards, supplier audit options, and quality agreement requirements. An example Supplier Management Standard Operating Procedure (SOP) and the Quality Agreement template will be reviewed during the course.
This course will also include a discussion on how to utilize risk-based quality tools to determine supplier classification. An example supplier risk assessment will be reviewed during the course. Finally, in order to understand the real-life consequences associated with non-compliant supplier management programs, recent FDA audit findings will be reviewed and discussed.
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.