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2-Day Course
Developing a Practical and Compliant Vendor Qualification Program

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For the Healthcare and Pharmaceutical Industry

This program offers a brand new compliant and implementation approach to Qualifying your vendors, creating a systematic formula to help increase the prospects for a successful and productive relationship with all outside vendors.   Know when a face to face audit is mandatory and when an onsite assessment is acceptable.  Learn also how to monitor vendors and track problems before they become major.  Students also receive cGMP training credit for the course to meet your regulatory expectations for annual cGMP training. 

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Course Outline

Speaker Qualifications

What is Vendor Qualification?

• Demonstrating Capability
• What are the Results of Poor Vendor Decisions?

What are Quality Systems?

• Process, Organizational Structure, Procedures and Resources used to Control Variables
• Vendor Qualification – A Separate Quality System

Getting Started

• The Q.U.E.S.T. Approach
• Question, Understand, Evaluate, Site-Audit, Track

Q – The Question Phase

• What Does a Potential Vendor Need to Supply?
• What is Needed From the Vendor?
• What is the Budget?

U – The Understanding Phase

• How Does the Potential Vendor Meet the Requirements?
• Supplying Administrative Information
• Supplying Samples
• Requesting Information from Multiple Vendors

E – Evaluation Phase

• Identification of the Best Potential Vendor
• Assess Each Vendor Against the Company Requirements
• Rate the Criteria and Make a Spread Sheet to Compare Vendor Results
• This is Not the Final Result

S – Site Audit Phase

• On-Site vs Off-Site Verifications
• Critical Suppliers vs Non-Critical Suppliers
• Examples of On-Site Verification Criteria
• Examples of Off-Site Verification Criteria
• Evaluating Audit Results
• Making the Final Decision

T – Track Phase

• Monitoring Qualified Vendors
• Monitor Vendors by Reviewing and Tracking Problems
• Requalify Vendors on a Periodic Basis
• Keep a Comprehensive Vendor File
• Summary

Determine What you Need

Review What Potential Vendor Can Supply

Assess Vendors to Narrow Down the List

Audit Potential Vendor to Select the Best Choice

Track Vendor’s Performance

Requalify on a Periodic Basis

cGMP Training Credit

• Competency Assessment Performed to Ensure All Attendees Fully Understand All Concepts Presented and Can Implement Them Before the End of the Training Course
• Documented Training Verification Provided Using Our Own Training Forms or Your In-House Training Form To Address FDA’s Requirement of Periodic cGMP Training

Free 1 on 1 Consulting From the Industry’s Top Expert

• Confidential One On One Consulting/Assistance at the End of the Course For Those That Sign Up In Advance at No Additional Cost.
• Get Answers to your Specific Situation Questions Without Airing your Firms “Laundry” to the Group

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Who Should Attend

Those who will benefit most from the pharmaceutical and healthcare industries include:

• Purchasing Management
• Managers and Directors of Quality and Regulatory affairs
• CEOs
• Presidents.