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.
- 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
- 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