Building a Vendor Qualification Program for FDA Regulated Industries

Why Should You Attend:

If you are looking for the answer to the following questions, you will certainly benefit from attending this webinar on building a vendor qualification program:

• Have you wasted hours, days, and weeks on qualifying vendors that you know cannot or will not meet your requirements?
• Has your approach to vendor qualification and vendor audits left you with internal CAPAs, customer audit items, or 483 observations?
• Have you wondered whether an onsite vendor audit is necessary in the eyes of the FDA?

Well, the answers to these and many more questions are now available in a simple to understand, yet detailed training session designed to help manufacturers of FDA regulated products build (or rebuild) a sustainable vendor qualification program.

Areas Covered in the Webinar:

• Structure for a sustainable vendor qualification program
• How change control and other quality programs feed into the vendor qualification program
• Audit forms/checklists and other vendor qualification program documents
• How to determine the best potential vendor
• What a potential vendor needs to supply before qualification
• How to initially identify vendors that meet your requirements prior to qualification
• On-site and off-site verifications
• Monitoring and re-qualification of vendors
• How to estimate costs and time associated with vendor qualification
• Responses to customer and regulatory audit observations associated with vendor qualification
• Common pitfalls to avoid when qualifying vendors

Who Will Benefit:

This course will provide valuable assistance and guidance to all FDA regulated companies for building sustainable vendor qualification program. The following job titles/ positions will benefit from attending this seminar:

• Internal Auditors
• Regulators
• Legal Departments
• Compliance Officers
• Purchasing Managers
• QC Managers
• QA Managers
• Quality and Sales Department Staff
• Compliance Consultants
• Senior Management

Jonathan M Lewis
Principal, Advanced Biomedical Consulting LLC

Jonathan M. Lewis, has over 22 years’ experience in the areas of quality control/quality assurance (QA/QC), manufacturing, regulatory affairs, validation, and project management in both industry and consulting roles. Mr. Lewis has experience in the medical device, diagnostic, biopharmaceutical, pharmaceutical, cosmetic, nutritional supplement, food, and animal feed industries.

Prior to founding Reliant FDA Experts (Reliant) (ABC), LLC, Jonathan worked for KMI/PAREXEL, a regulatory compliance and validation consulting firm, in increasing roles of responsibility from an entry-level Validation Engineer to an Associate Director of Consulting. He has worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/Validation Manager. In addition, he has worked at Telectronics Pacing Systems, a medical device manufacturer, in the Sterility Assurance Laboratory.

Topic Background:

While being conscious of the products and services purchased is good practice for consumers and most businesses, it is a regulatory requirement for FDA regulated industries. For these organizations, the decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be well informed and documented through a vendor qualification program. The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company.

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