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.
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 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 real-life consequences associated with non-compliant supplier management programs, recent FDA audit findings will be reviewed and discussed.
Areas Covered in the Session :
Part 1 – Review Supplier Management Regulatory Guidance
Part 2 – Elements of a Robust Supplier Management Program
- Standard Operating Procedure (SOP) example
- Quality Agreement template review
- Initial qualification
- Monitoring / Scorecards
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 Should Attend:
- Quality Assurance Departments
- Supply Chain Departments
- Regulatory Affairs Departments
- Compliance Departments
- Operations Departments
- Contract Manufacturing Organizations (CMOs)
- International Suppliers