Establishing a Robust Supplier Management Program
60 Minutes
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 webinar will review regulatory guidance governing Suppliers; as well as, all the elements of a robust supplier management program; including, initial qualification, supplier performance monitoring, 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.
WHY SHOULD YOU ATTEND?
This webinar 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
This webinar 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
- 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
- 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
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, 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.
Upcoming Webinars
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
By:Marcia Zidle
Nov. 30, 2023
10:00 AM PDT | 01:00 PM EDT
Strategic Interviewing & Selection: Getting the Right Talen…
By:Pete Tosh
Nov. 30, 2023
12:00 PM PDT | 03:00 PM EDT
Conflict Resolution in a Remote Workplace
By:Natasha Nurse
Nov. 30, 2023
10:00 AM PDT | 01:00 PM EDT
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
By:Dr. Susan Strauss
Dec. 1, 2023
12:00 PM PDT | 03:00 PM EDT
Workplace Investigations 101: How to Conduct your Investiga…
By:Dr. Susan Strauss
Dec. 4, 2023
10:00 AM PDT | 01:00 PM EDT
Cleanroom, Microbiology and Sterility Assurance Practices f…
By:Kelly Thomas
Dec. 4, 2023
12:00 PM PDT | 03:00 PM EDT
5 Key Components of Good Manufacturing Practices to obtain …
By:Meredith Crabtree
Dec. 5, 2023
12:00 PM PDT | 03:00 PM EDT
Successfully Negotiating the Labor Agreement
By:Gerry McLaughlin
Dec. 5, 2023
12:00 PM PDT | 03:00 PM EDT
Understanding the incredible uses and fallbacks of ChatGPT
By:Justin Muscolino
Dec. 5, 2023
10:00 AM PDT | 01:00 PM EDT
Wage And Hour Laws: Ensuring Compliance With The Fair Labor…
By:Diane L. Dee
Dec. 5, 2023
10:00 AM PDT | 01:00 PM EDT
How to Manage Conflict in the Workplace
By:Susan Schoenfeld
Dec. 5, 2023
10:00 AM PDT | 01:00 PM EDT
Neutralizing Harassment - How to Promote the Proactive Pers…
By:Beverly Beuermann-King
Dec. 5, 2023
12:00 PM PDT | 03:00 PM EDT
Human Error Reduction Techniques for Floor Supervisors
By:Ginette M. Collazo
Dec. 6, 2023
10:00 AM PDT | 01:00 PM EDT
Hybrid Workplace: 10 Best Practices to Manage Your Team’s P…
By:Marcia Zidle
Dec. 6, 2023
12:00 PM PDT | 03:00 PM EDT
Using Better Managerial Decision Making - to get great resu…
By:Bill Straubinger
Dec. 6, 2023
12:00 PM PDT | 03:00 PM EDT
Changing Behavior: Why Rewards and Punishments Often Aren't…
By:Rebecca Staton-Reinstein
Dec. 6, 2023
12:00 PM PDT | 03:00 PM EDT
Excel - Pivot Tables - The Key To Modern Data Analysis and …
By:Mike Thomas
Dec. 7, 2023
10:00 AM PDT | 01:00 PM EDT
Using Stay Interviews To Improve Employee Retention & Engag…
By:Pete Tosh
Dec. 7, 2023
12:00 PM PDT | 03:00 PM EDT
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
By:Patrick Haggerty
Dec. 7, 2023
12:00 PM PDT | 03:00 PM EDT
Using High-Performance Coaching for Managers to Address Per…
By:William J. Rothwell
Dec. 7, 2023
12:00 PM PDT | 03:00 PM EDT
FDA Technology Modernization Action Plan (TMAP) and Impact …
By: Carolyn Troiano
Dec. 12, 2023
10:00 AM PDT | 01:00 PM EDT
FDA Audit Best Practices - Do's and Don'ts
By: Charles H. Paul
Dec. 12, 2023
10:00 AM PDT | 01:00 PM EDT
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
By:Marcia Zidle
Dec. 13, 2023
10:00 AM PDT | 01:00 PM EDT
Become an excellent Critical Thinker to greatly improve you…
By:Bill Straubinger
Dec. 13, 2023
10:00 AM PDT | 01:00 PM EDT
Learn the Do's and Don'ts of Opening Business Bank Accounts
By:Justin Muscolino
Dec. 14, 2023
12:00 PM PDT | 03:00 PM EDT
Project Management for HR, Administrative Professionals, an…
By:Rebecca Staton-Reinstein
Dec. 15, 2023
12:00 PM PDT | 03:00 PM EDT
Writing Effective 483 and Warning Letter Responses
By:Kelly Thomas
Dec. 19, 2023
12:00 PM PDT | 03:00 PM EDT
Dealing With Difficult People In Life & Work
By:Paul J. Cline
Dec. 19, 2023
10:00 AM PDT | 01:00 PM EDT