How to Establish, Conduct and Maintain an Effective Supplier Management Program
Mr. Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical, biotechnology, and cosmetics industries. Mr. Christie is currently the Chief Operating Officer for VTS Consultants, Inc. located in Amherst, MA. Specifically, his responsibilities include quality system auditing, GMP training, and serving as a subject matter expert for aseptic manufacturing processes, equipment and utilities, medical devices, and solid dosage processes on a global basis. Mr. Christie also performs vendor/supplier audits (GXP, GLP, GCP), site pre-approval inspections and assists clients with addressing and correcting regulatory observations. He possesses extensive knowledge of regulations covering 21 CFR Parts 210-211, 11, and 820: ISO.
Mr. Christie was the Validation Manager at Parke-Davis' Sterile Products Facility where he was involved in the review and approval of all facilities, equipment, and system commissioning/qualification activities. He had routine interaction with the FDA, Health Canada, and European inspectors (EMEA), corporate management, and third party contract-manufacturing representatives to defend validation practices and to assure regulatory compliance for the manufacture of aseptically produced products.
Mr. Christie is a speaker and trainer for several professional organizations in the US, Canada, Europe, and Asia and is a published author of several articles dealing with the challenges of aseptic processing. Additionally, Mr. Christie served as a member of the ISPE’s Professional Certification (PCC) Commission as an Examination Development Committee (EDC) member.
The requirement for qualifying suppliers, as part of the Quality System Requirements covering the supply chain for companies, is one that presents significant challenges to the industry. The challenges include the number of suppliers to qualify, the risk to product quality that each represents, and the resources and cost to manage the program. This webinar will look at the basics of establishing a compliant supplier qualification program from developing the procedure, to its implementation, challenges encountered, and then steps for continuous monitoring of it.
Actual case studies will be used for how best to prepare for supplier audits, an audit checklist will be reviewed and provided for discussion, along with addressing questions and concerns from the attendees.
- Regulatory requirements for supplier qualification
- Basic topics to be used for the selection of suppliers challenges to the program and the need for routine evaluation
- Quality agreements, what they include, and how to implement
- The follow-up to findings and responses. How to address single-source suppliers that do not fully meet expectations
Course Level - Basic
Who Should Attend
- Suppliers (services, raw materials, and components)
- Quality Assurance and Quality Control
- Third-party co-ordinators
Why Should You Attend
This webinar will help attendees understand the importance and quality system requirements for establishing a supplier management program. Since auditors look for a cause to be defined in deviations or out of specification results, their focus will shift to the supplier management program when the cause is attributed to “supplier problems”. The challenges faced today by companies are the number of suppliers the industry depends on and how can you manage such a project when that number approaches and exceeds at least 100. It becomes a migraine and relief is critical.