Pragmatic and Effective Vendor Qualification Program for cGMP Compliance

Regulatory agencies such as US FDA and others expect pharmaceutical companies to treat their suppliers and contractors as an extension of their own operation. Hence oversight of their vendors’ quality compliance is of paramount importance.

A robust, but pragmatic and effective vendor qualification program must be established by the manufacturer of drugs, biologics, medical device, & combination products. This will also apply to the vendors and contractors who have the responsibilities of oversight over their own suppliers and contractors.

Supply chain is becoming increasingly complex due to changing business & regulatory environment in the recent time. Importance of robust due diligence via effective audits of the supply chain is being emphasized by the regulatory agencies around world. Hence, setting up on effective and pragmatic vendor qualification program has become a big challenge to the industry.

Attendees will learn how they can establish such a robust, risk based vendor qualification program in a cost effective manner, but in compliance with the applicable regulatory requirements.

Areas Covered in the Session :

• Changing current business and regulatory environment
• Complexity of supply chain & Strategies for compliance
• Regulatory & quality compliance challenges
• Importance of vendor selection process & potential business & regulatory consequences
• Elements of vendor qualification program
• How to set up a robust, pragmatic & cost effective vendor qualification program for regulatory compliance. Win-Win Strategy & Partnership with vendors
• “Seeing is believing” & setting up a suitable, cost effective audit program for compliance
• Performance monitoring & effective communication
• Application of risk management principles & life cycle approach to vendor qualification program

Who Should Attend:

• Quality Assurance Departments
• Quality Control Departments
• Supply Chain Departments
• Compliance Departments
• Research and Development Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Sales and Distribution Departments
• Marketing Departments
• Documentation Departments
• Project Managers

Course Director: NADA KUGANATHAN

Nada Kuganathan is a seasoned Quality and Compliance professional with extensive experience, knowledge and proven track record for more than 30 years in the pharmaceutical industry. This experience included branded, generic, contract and consulting business environment in QA, QC, Compliance, Vendor Qualification, Training, and in the global arena. Nada is currently the president & principal consultant of Enkay Consulting Services Inc., CA, USA. In this capacity, Nada has successfully completed several consulting activities with large, medium and start-up pharmaceutical companies related to Quality, Compliance, Vendor Qualification & Supplier Audits, Training and US FDA Inspection Readiness. His work involves a variety of dosage forms of drugs, combination products (both sterile and non-sterile), biologics, and OTC. 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.