Online Webinar 2015 - Building a Sustainable Vendor Qualification Program

Overview:
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.
This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.
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:
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:
Internal Auditors
Senior Management
Compliance Officers
QA Managers
QC Managers
Purchasing Managers
Speaker Profile
Jonathan M. Lewis has over nineteen years’ experience in the areas of quality control/quality assurance (QA/QC), 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 food industries.