Qualification, Contracts 2025 - Supplier Management for Device makers and Drugmakers: Qualification, Contracts and Audits Course

Supplier Management Training Overview
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.
Understand the benefits of effective supplier management.
Learn about the regulatory requirements for supplier management.
Understand how to develop a strategy for suppliers based on your supply chain
Be able to analyse the cost of manufacturing vs. purchasing.
Understand how to select a supplier or contract manufacturer.
Understand the basics of building a supplier relationship.
Be able to develop a quality agreement that provides valuable guidance.
Learn how to perform risk assessments on suppliers and how to make decisions based on that assessment.
Learn how to develop a plan for supplier performance monitoring.
Understand how to manage failures and how to work with a supplier for improvement.
Understand the methods of supplier assessment and when to apply each.
Learn techniques for auditing a supplier and for follow-up and closure of the audit.
Learn how to effectively manage supplier exits and the transition to a new supplier.
(RAPS - This course has been pre-approved by RAPS as eligible for up to 10 credits towards a participant's RAC recertification upon full completion)
This live training seminar includes the following for each registered attendee:
A copy of the presentation slides
A certificate of training for attendee training records
10 hrs of Instructor led interactive virtual session Live.
Why Should You Attend
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.
Agenda
The benefits and components of a supplier management program
Regulatory requirements for managing suppliers and contract manufacturers
Strategic decision making for good supplier management
How to manage risk and reduce the costs associated with having suppliers
The steps involved in selecting and onboarding a supplier
Developing good supplier relationships including managing improvement and nonconforming events
Writing effective and useful quality agreements
Reviewing supplier performance and making performance-based decisions
How to perform a desktop assessment and a supplier audit (and when to use each)
Managing supplier transitions
many more..
Who Will Benefit
Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
Quality Assurance Managers,
Quality Control Supervisors,
Quality Engineers,
Procurement Professionals,
Drug Development Scientists,
Medical Device R&D Engineers
Supply Chain Managers
This live training seminar includes the following for each registered attendee:
A copy of the presentation slides by download
A certificate of participation for attendee training records
Q/A Session
Free Handouts on Supplier Management
How to Attend:
All WCS Seminar live training programs audio and visuals are delivered via Go to Webinar with a basic system requirement of a computer with internet access. You do not require a Go to Webinar account to join WCS Seminar’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.
Kelly Thomas, Head Of Quality Assurance (USA)
Highly experienced Quality Assurance / Quality Control / Regulatory Compliance leader with experience in API, biologics / biotech, both aseptic and terminally sterilized manufacturing processes, medical devices, drug / device combination products, and all pharmaceutical dosages (Sterile Injectable, OSD, Controlled Substances, Aerosols).
Over 20 years’ experience leading facility start-ups, PAI and Routine cGMP Surveillance inspections. Highly successful global regulatory and ISO compliance history with inspections including FDA, EMEA, IMB, JP, Health Canada, and ANVISA. Highly committed to implementing effective contract manufacturing, supplier management and Internal audit programs.
Strengths include developing staff, maintaining and developing budgets, implementing robust quality systems, communicating and implementing clear Key Performance Metrics (KPIs), conducting Quality Management Reviews and Executive Reports, implementing Lean Six Sigma programs, influencing and implementing positive change, and leading cross-functional teams.