Auditing and Qualifying Suppliers and Vendors
Agenda: Day One
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
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.