PTI - international

I. Explain the Fundamentals of Supplier Qualification

• Explain the current state of affairs
• Examine the essential elements of supplier qualification
• Define key terms
• Assess the difference between qualified vs. certified

Exercise: Review Participants' Backgrounds, Experiences with Supplier Qualification and Expectations for the Course

II. Examine the Regulatory Requirements for Supplier Qualification

• Define the requirements for Medical Devices, Pharmaceuticals and Biotech Products 
• Examine purchasing controls 
• Explore the quality rationale

Exercise: Case Study Focusing on a Medical Device Vendor

III. Define the Attributes of a Successful Supplier Qualification Program

• Determine what makes a successful supplier qualification program 
• Examine different types of suppliers 
• Assess which suppliers and services need to be qualified 

Exercise: Prepare Flip Charts Outlining Important Considerations for Various Supplier Types

IV. Create the Quality Agreement

• Identify the purpose of the quality agreement 
• Define the scope of the document 
• Outline the recommended sections to include in a quality agreement

Exercise: Interactive Discussion of Real World Experiences

V. Perform an Initial Assessment of the Supplier

• Establish specifications and expectations 
• Employ risk analysis 
• Demonstrate selection and qualification process to FDA 
• Identify common problem areas to assess 
• Customize the supplier assessments 
• Decide when to use surveys vs. on-site assessments
• Develop and maintain the supplier dossier 
• Implement a global management strategy

Exercise: Analyze Sample Supplier Questionnaire/Checklist