Training Course Syllabus:

Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program?

Objectives of the Presentation

• Describe the requirements for a compliant vendor/supplier program


• Discuss how to apply a risk-based approach to the supplier/vendor selection process


• Discuss the process for supplier assessments, pre-approval and re-assessment


• Discuss quality agreements and supplier agreements


• Discuss how to handle problem vendors and disqualifying a supplier/vendor

Why should you Attend

Time is money and costly delays from vendors/suppliers can be painful. Work to avoid these challenges by having a strategic risk-based vendor qualification program. Make sure your vendor requirements are well vetted in advance and avoid wasting time and money on vendors that will not be able to perform.

Do you have back-up vendors in place in the event something would go wrong for all your critical supplies? How fast can you qualify a new vendor selection process?

Who will Benefit

This webinar will provide valuable assistance to all in pharmaceutical and biotech industries who manufacture products for clinical and commercial uses. The employees who will benefit include:

• QA Staff and Management
• Regulatory Affairs Staff and Management
• QC Staff and Management
• Compliance Auditors
• Manufacturing Management
• Project Managers Working in the CMC Arena
• Senior Managers and Executives
• Process Scientist and Management
• Supply Chain and Logistics Managers

Areas Covered

• We will discuss the process for a compliant vendor/supplier program. This includes having a risk-based approach to auditing your vendors and the selection process


• We will discuss the assessment process including pre-approval with the use of surveys and how to re-assess vendors


• We will review the different types of vendors and the frequency one may consider in evaluating them


• We will highlight various challenges one might have with the vendor qualification process and how to resolve them


• We will address quality agreements and supplier agreements covering potential pitfalls


• Disqualification of vendors will also be addressed


• We will also review examples of warning letters from the FDA on regulations and regulatory compliance

Seminar Summary:

Many companies depend upon a vendor or supplier for some product or service and need to ensure compliance. At the end of the day if the manufacturer fails to ensure oversight of the vendors, they will be held responsible. Manufacturers are responsible for ensuring the quality and integrity of their product and its components. We will review challenges one may encounter with the vendor qualification program including disqualification and how to handle those issues. (see full course description)

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