This course will review regulatory guidance governing Suppliers and the elements of a robust supplier management program including, initial qualification, supplier performance monitoring, and scorecards, supplier audit options, and quality agreement requirements. It will discuss how to utilize risk-based quality tools to determine supplier classification with a risk assessment example. Recent FDA audit findings will also be reviewed.
WHY SHOULD YOU ATTEND?
Regulatory expectations are clear about manufacturers’ responsibility regarding supplier quality oversight. All regulatory agencies agree that pharmaceutical and medical device manufacturers 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 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 of 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.
AREA COVERED
- 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
- Onboarding
- Monitoring / Scorecards
- Development
- Phase-Out
- Part 3 – Review of Risk Analysis Tools and Recent Audit Observations
- Review an example of 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 for US-based clients
- QA/QC/Compliance/Regulatory affairs professionals
Regulatory expectations are clear about manufacturers’ responsibility regarding supplier quality oversight. All regulatory agencies agree that pharmaceutical and medical device manufacturers 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 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 of 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.
- 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
- Onboarding
- Monitoring / Scorecards
- Development
- Phase-Out
- Part 3 – Review of Risk Analysis Tools and Recent Audit Observations
- Review an example of FMEA classifying different suppliers by criticality
- Review recent FDA audit observations applicable to supplier management
- 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 for US-based clients
- QA/QC/Compliance/Regulatory affairs professionals
