Building a Sustainable Vendor Qualification Program
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Documented vendor qualification prior to using a vendor of products or services is a regulatory requirement for FDA regulated industries. The decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be predefine 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.
Why should you Attend: If you are looking for the answer to the following questions, you will clearly benefit from attending this webinar on building a vendor qualification program which clearly defines the requirements and recommended sustainable implementation:
- 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 Session:
Who Will Benefit:
- 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
- Internal Auditors
- Senior Management
- Compliance Officers
- QA Managers
- QC Managers
- Purchasing Managers
Jonathan M. Lewis has over twenty-two years' experience in the areas of executive management, quality control (QC), quality assurance (QA), 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, dietary supplement, food, and animal food industries.
Prior to founding Reliant FDA Experts, a division of Advanced Biomedical Consulting (ABC), LLC, Mr. Lewis 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.
Mr. Lewis has also worked at RPScherer (Cardinal Health), a contract and proprietary solid oral dose pharmaceutical manufacturing facility, as the QC/Validation Manager. In addition, Mr. Lewis has worked at Telectronics Pacing Systems, a medical device manufacturer, as a Sterility Assurance Laboratory Technician.