2022 - Establishing a Robust Supplier Management Program

OVERVIEW
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
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 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
SPEAKER PROFILE
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.
For more detail, please click on this below link:
https://bit.ly/3wAMhF5
Email: info-AT-247compliance.us
Tel: +1-661-336-9555
https://www.linkedin.com/in/whitney-jones-87357317...