Vendor qualification program must be customized for the type of products one manufactures, so that the program will be effective, robust, pragmatic, but at the same time, it will meet the applicable regulatory agencies’ requirements and expectation. Such a task is always challenging, and is not easy to achieve if there is no systematic approach to plan, design, implement & to continuously monitor the program.
It should be also recognized that suppliers are based around the globe, and the supply chain is becoming increasingly complex. Hence conducting effective onsite audits of global suppliers and contract facilities for cGMP require additional resources, so establishing risk based and cost effective audit program is also of prime importance.
Why You Should Attend:
This workshop will consist of theoretical and hands-on practical aspects of learning. This will include US FDA and EU regulatory agencies’ current initiatives and expectation on Vendor Qualification Program.
US FDA and other regulatory agencies consider suppliers and contractors as extension of company’s own operation. Hence, oversight and due diligence of vendor activities via Quality agreements and robust onsite audit programs are essential.
This workshop will give examples of setting up such requirements in a customized manner for the type of products such as drugs, biologics, combination products that companies manufacture. This will include pharma company’s vendors to set-up their own vendor qualification program.
Learning Objectives:
Changing current business and regulatory environment in the pharmaceutical industry and impact on the vendor qualification program
Complexity of supply chain & Communication challenges
Regulatory & Quality Challenges & Strategies for meeting such challenges
Understanding of vendor qualification, evaluation & communication of potential risks and strategies for mitigating such risks
Concepts and principles for a robust, but pragmatic and cost effective vendor qualification program
Setting up a science, system and risk based audit program catered for the type of company
Performance monitoring and effective communication
Life cycle approach to vendor qualification program,
Opportunity to work in a small group. hands-on workshop setup to design and develop a customized vendor qualification program. This will be based on the lesson learned during the seminar. A case study exercise will be given to each group. Participants from each group will present their developed program to all attendees. Instructor’s guidance & support will be available throughout this session. Participants will be able join the applicable small group such as drugs, biologics, combination products or vendor.
Ample opportunities to ask questions from the course instructor during the seminar.
Oversight of Outsourcing activities
Who Should Attend
Quality Assurance Specialists & Management Staff
Compliance Specialists & Management Staff
Quality Auditors & Management Staff
Buyers & Supply Chain Staff and Management as applicable
Project related QC Analysts & Management as applicable
Regulatory Affairs Staff & Management
Supplier / Contractor / Distributor Representatives as applicable
Production & Management Staff
R&D & Management Staff
Transport company personnel as applicable (QA/Operation)
Project Management as applicable