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. 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 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