Establishing A Robust Supplier Management Program

Duration 90 Mins
Level Basic & Intermediate
Webinar ID IQW20H0882

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

Overview of the webinar

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

Who should attend?

  • 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 supplier
  • Suppliers outside the US looking to US-based clients
  • QA/QC/Compliance/Regulatory affairs professionals

Why should you attend?

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.

Faculty - Ms. Kelly Thomas

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.

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