Effective Vendor Qualification and Validation of Reagents in a GLP/GMP Laboratory| Oct. 28, 2013, 2 PM EDT | Graham

Effective Vendor Qualification and Validation of Reagents in a GLP/GMP Laboratory| Oct. 28, 2013, 2 PM EDT | Graham

September 19th, 2013 // 1:53 am @

Background

This one hour Expertbriefings.com Webinar will teach you what to look for when it comes to vendor qualification and validation for reagents in a GLP/GMP laboratory. It will teach what to ask for to qualify reagents, whether for completely new purposes or existing uses, and to validate that the reagents are what the manufacturer claims to be selling.

Why Should You Attend

There will be a constant need to source reagents from a variety of vendors for all sorts of uses in a GLP/GMP laboratory. While there will always be a multitude of factors beyond mere quality, you need to know what a vendor is capable of delivering and make sure that what is on offer is what can be delivered to your laboratory for necessary use.

This virtual seminar will teach you what to look for in vendors, from the necessary standards they should be able to manufacture at to the data they should be able to send with their reagents to pit falls that belie issues with many common reagents. Then, you will learn to validate if the reagents work according to specifications and are suitable for use. Also, you will learn how to manage vendor relationships for the maximum benefit of your laboratory, since relying on one sole vendor can be risky for laboratory needs.

What You Will Learn

This webinar will help you learn how to use qualify and validate vendors for reagents in a GLP/GMP laboratory The webinar will include the following critical information you will need:
1) How to select vendors for reagents?
2) What does the reagent vendor have to be capable of doing in order to be suitable for usage in a GLP/GMP laboratory?
3) How and when to be flexible with vendor requirements, and what steps need to be taken in order to allow for flexibility?
4) What information needs to be provided in order for reagent validation to begin?
5) What kind of work needs to be done to validate the reagents for a vendor?
6) How to prioritize and manage vendor relationships to meet key business needs?

Who Should Attend

This topic applies to personnel / companies in the biotechnology and pharmaceutical industry. The employees who will benefit most include:
• Senior management
• Quality Assurance
• Research and Development

What You Receive

With your order, we would like to offer you these six items at no added cost:

  • Powerpoint slides to share
  • Downloadable recording or CD
  • Article – 21 CFR Part 11 Enforcement – Where Is FDA Headed? By John Avellanet, Cerulean Associates
  • Article – 10 Ways to Control Compliance Costs – By John  Avellanet, Cerulean Associates
  • Guide – An Executive Guide to Quality by Design – By John Avellanet, Cerulean Associates
  • Newsletter – FDA Digest – By Expertbriefings.com. Latest FDA regulatory news, and recent 483 and warning letter analysis – 12 issues only $399.00

About the Speaker

Todd Graham is a masters-level bench scientist and medical technologist with a host of experience in both the clinical diagnostics and biotechnology fields. He has work for a number of start-up firms in the clinical diagnostics and biotechnology industries, as well as worked for larger firms within both industries. He has a broad level of expertise in assay development for quality control, pharmaceutical development and clinical diagnostics. His particular levels of expertises are molecular diagnostics, PCR, ELISA, quality control and training of bench level personnel in clinical diagnostics and biotechnology. He is also in the process of establishing a consultancy that assists academic labs in transitioning their research to industry by verifying and improving the quality of their work.


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