Effective management of suppliers and contract manufacturers is an integral component of a quality management system. Suppliers are an integral part of the supply chain and, therefore, the process of production and delivery should by understood and supplier relationships developed and improved. Supplier failures can increase the cost of poor quality through excess inventory, downtime, additional testing, and customer satisfaction. On the other hand, a significant strategic advantage can be gained by excellent supplier management. One of the seven quality principles of ISO 9001 is to build relationships with suppliers because it is a critical component of sustained success.
Pharmaceutical and medical device manufacturers have a mandated responsibility for ensuring the suppliers meet regulatory requirements and produce good quality product. FDA regulations CFR 210 and 211 require pharmaceutical companies to assure the quality of the product they put into interstate commerce regardless of where it or any of its components were manufactured. The Q10 Pharmaceutical Quality System Guidance provides additional details on the agency’s expectations for supplier management. For Medical Device Manufacturers, 21 CFR 820.50 places the burden on the purchasing company to establish purchasing controls. European regulations similarly require effective supplier quality management.
This 2-day course will cover managing a supplier for the entire lifecycle of the relationship, beginning with identification and qualification of a supplier and continuing through building a relationship, risk management, ongoing assessment (including auditing) and finally planning for an exit. The course will show attendees how to use risk assessment for ranking suppliers and reducing the number of audits that are necessary to effectively manage suppliers. Strategies for determining whether a supplier will be sole source will be included. Exercises will help attendees develop their own supplier scorecard based on the requirements of their company and develop quality agreements that will ensure clear lines of communication. Attendees will take away strategies for the ongoing monitoring of supplier process performance and for managing nonconforming incidents and changes.
Who will benefit:
In the pharmaceutical, medical device, cosmetic, or personal care industries: quality assurance managers, quality control laboratory supervisors, quality engineers, procurement professionals, drug development scientists, medical device development scientists, supply chain managers
Peggy Kwoka has more than thirty years of experience in pharmaceutical, cosmetic consumer health and medical device industries including twenty years in Quality Assurance management and consulting. She has managed or provided expertise for more than ten US FDA inspections.
Peggy is currently working with pharmaceutical companies to develop effective quality systems through her consulting firm, Quality GMP Solutions, LLC. She focuses on improving her client’s manufacturing and quality processes to enhance their regulatory compliance profile. She previously held quality assurance management roles at Colgate-Palmolive Company and GlaxoSmithKline.