Establishing a Robust Supplier Management Program

Why Should You Attend:

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 to regulatory requirements and consistently meet established expectations. Therefore, it is essential pharmaceutical and medical device organizations develop and implement 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 present an example Supplier Management Standard Operating Procedure (SOP) and Quality Agreement template. 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 real-life consequences associated with non-compliant supplier management programs, recent FDA audit findings will be reviewed and discussed.

Areas Covered in the Webinar:

• Part 1 – Review Supplier Management Regulatory Guidance
• ISO
• ICH
• FDA
• EU
• Part 2 – Elements of a Robust Supplier Management Program
• Standard Operating Procedure (SOP) example
• Quality Agreement template review
• Initial qualification
• Onboarding
• Monitoring / Scorecards
• Development
• Phase-Out
• Part 3 – Review of Risk Analysis Tools and Recent Audit Observations
• Review an example FMEA classifying different suppliers by criticality
• Review recent FDA audit observations applicable to supplier management

Who Will Benefit:

• QA Managers and Associates responsible for supplier management
• Supply Chain Managers and Associates
• Operations Managers
• Managers and QA personnel from Contract Manufacturing Organizations (CMOs)
• Regulatory and quality professionals working for US companies that are considering foreign suppliers
• Suppliers outside the US looking to US-based clients
• QA/QC/Compliance/Regulatory affairs professionals

Kelly Thomas
Vice President, Americas Quality Operations

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, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.

Utilizing strategic thinking, risk-based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.

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