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.
- 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 to join the applicable small groups such as drugs, biologics, combination products or vendor categories during the hands-on workshop.
- Oversight of Outsourcing activities
- Ample opportunities to ask questions from the course instructor during the seminar.
DAY 1 : (9 AM – 4.30 PM)
9.00 – 9.30 AM: Introduction & Opening discussion
9.30 – 10.30 AM:
- Changing business & regulatory environment & Impact on Vendor Qualification Program
- Quality & Regulatory requirements, Challenges & Potential risk mitigation
- Key elements of Vendor Qualification Program
10.30 – 10. 45 AM: Break
10.45 – 12.00 PM:
- Understanding of geographical, business and regulatory landscape of the vendors & complexity of the supply chain
- Risk based approach to vendor qualification
- Communication and Contractual & Quality Agreements
- Existing & Prospective Vendors
- Database for vendor information. Electronic Vs Manual System, Challenges & Resolution.
12.00 PM – 1.00 PM: Lunch
1.00 – 3.00 PM:
- Establishing robust, cost effective, but pragmatic vendor qualification program
- Establish basic principles for a robust program
- Establish vendor qualification policy under various business models
- Maintenance of the vendor qualification program, challenges & risk mitigation
- Communication & partnership with vendors to achieve common goals
3.00 – 3.15 PM: Break
3.15 – 4.30 PM:
- Oversight of outsourcing activities
- Approach to Contract manufacturing & Contract testing
- Handling Contractors, Consultants & Service Providers
DAY 2 : (9 AM – 4 PM)
9.00 – 10.15 AM:
- Science, Risk, and System based audit program
- Audit approaches to handle various scenario
- Strengths, Weakness, Opportunities & Threats (SWOT) of the program
- Auditor selection & training
- Audit process
10.15 – 10.30 AM: Break
10.30 – 12.00 PM:
- Performance Monitoring & Effective Communication
- Quality Metrics & Trending
- Life cycle approach to Vendor Qualification
- Handling regulatory inspection with regard to vendor qualification
- Pre-Approval Inspection vs Routine GMP Inspection
- Suppliers’ vendor qualification program
12.00 – 1.00 PM: Lunch
1.00 – 3.15 PM: Hands-on Workshop
3.15 – 3.30 PM: Break
3.30 – 4.00 PM: Question & Answer Session
Prior to consulting, Nada served as Executive Director, Global Compliance with Actavis (Formerly Watson and now Allergan). During his career in management positions in QA and Compliance areas, he had conducted numerous strategic quality compliance audits in the lead capacity which included numerous supplier/contractor audits such as API, cell banks, excipient, contract manufacturing, laboratories, R&D facilities, and distribution centers for small and large molecule pharmaceutical products around the world. This also included due diligence audits for product and company acquisition. Nada has actively participated in leadership roles in successful strategic vendor qualification projects at a global level.
He was a member of the board of directors & chair of the evening seminar committee of Pharmaceutical Sciences Group of Canada (1999-2001) and also a working group member of the auditor qualification team for Rx 360, an international pharmaceutical supply chain consortium (2011-2012). Nada has delivered numerous presentations to pharmaceutical and API industry professionals on QA, Compliance, Auditing, Validation and Microbiology/Aseptic topics via leading professional organizations such as PDA, ISPE, IVT, CBI, SWE, PSG in the US, Canada, Europe, and India.
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