• Health Canada, FDA and EU GMP Requirements
• Essential Components of an Effective Supplier Qualification Program
• Constructing Effective Quality Agreements
• Determining which Suppliers and Services Need to Be Qualified
• Requirements for Medical Devices, Pharmaceuticals and Biotech Products
• Demonstrating your Selection and Qualification Process to Regulatory Authorities
• Supplier Qualification SOP
• Implementing a Global Management Strategy
• Using Third Party Auditors
• Maintaining Proper Documentation of Supplier Audits
• Utilizing Compliance and Quality Systems for Supplier Qualification program
• Determining the Regulatory Responsibilities of a Sponsor
• Steps and Actions for Supplier Non-Compliance
• Change Control and Managing Supplier Change
• Developing a Vendor Management Procedure
• Auditing Contract Testing Laboratories
• Auditing Software and Computerized System Supplier

This two day course and workshops series program is directed toward Directors, Managers, Supervisors, Analysts, and Associates in Pharmaceutical, Biopharmaceutical, Medical Devices and allied industries with core responsibilities in the following areas:

• Quality Assurance
• Quality Control
• Regulatory Affairs
• Auditing
• Materials Inspections
• Purchasing
• Contract Laboratories
• Change Control
• Validation
• API Manufacturers
• Product Evaluation
• Manufacturing
• Documentation
• Technical Writing
• Training
• Consulting