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
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
Speakers
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.
