10:00 AM - 04:00 PM
Day 1

Understanding the Basics of Quality Systems
- Regulatory References
- Quality System and Qualification Terminology

The Components of a Sustainable Vendor Qualification Program
- Vendor Requirements
- Vendor Type Classifications
- Audit Forms/Checklists
- Vendor Information Files
- Approved Vendor List
- Requalification Schedule
- Standard Operating Procedures (SOPs)

Other Programs that Feed the Vendor Qualification Program
- Change Control
- Complaint Handling
- CAPAs
- Deviation Management
- Sales

The Question Phase—What a Potential Vendor Needs to Supply
- Vendor Requirements
- Budget Consideration
- Documentation of Requirements
- Understanding and Commitment by Internal Parties

Understanding Phase—How Vendors Meet the Requirements
- Initial Contact with Potential Vendors
- How to Supply Vendor with Company Requirements
- Contents of a Vendor Package
- Obtaining Multiple Vendor Packages
- How to Assess Packages for Adequacy and Completeness

Evaluation Phase—Determining the Best Potential Vendor
- Requirements for Entering the Evaluation Phase
- Purpose of the Evaluation
- Format of the Evaluation
- Using Rating Systems
- End Result of the Evaluation Phase

Site Audit Phase—On-Site and Off-Site Verifications
- Classification of Vendors
- On-Site vs. Off-Site Audits
- On-Site Verification Form
- Off-Site Audit Checklist
- How to Score the Audit
- Options for Rejected Vendors

Track Phase—Monitor and Requalify
- Importance of Continuous Monitoring
- Requalification Schedule
- How to Requalify a Vendor
- Vendor Information File

Time and Costs Associated with Vendor Qualification
- Estimating Time Associated with Each Vendor
- Hidden Costs of Vendor Qualification
- Estimating Costs of Using Consultants

Responding to Audit Findings Associated with Vendor Qualification

10:00 AM - 04:00 PM
Day 2

- Site Audit Phase - On-Site and Off-Site Verifications

- Practical Application # 1 - Qualifying a Services Vendor

- Practical Application # 2 - Qualifying a Raw Material Vendor

- Practical Application # 3 - Vendor Qualification 483 Response

- Individual/Open Q&A Session