A quality agreement defines the relationship between the customer and the contract manufacturer. This presentation explores why quality agreements are necessary and why they are beneficial to both parties.

      a.  Origins of the concept

      b.  What is the purpose

      c.  The FDA connection

      d.  Who is it for

      a.  For the customer

      b.  For the manufacturer

      c.  How to define the purpose

      a.  Guidance document suggestions

      b.  For the customer and manufacturer

      a.  The contract

      b.  What does not belong

      c.  Key points to include

 

You will benefit from purchasing this web seminar if you are a Vice President, Director or a Supervisor of the following departments at a pharmaceutical, biotechnology or medical device company.

Mr. Vadja is an experienced senior executive with backgrounds in pharmaceuticals, IVD devices, diagnostics and general instrumentation including electronic and optical assembly. He is a frequent speaker, nationally and internationally, on validation, process and design issues. His expertise includes process development, manufacturing, materials, engineering, facilities design and management, QC/QA, IT, marketing and regulatory affairs. Special skills include animal husbandry and facility designs, process and utilities validation and business development.

Prior to BFC, Mr. Vajda was at Centaur Pharmaceuticals from January 1997 as Director of Operations and became Vice President in February 1998 and Senior Vice President, Operations in charge of Process Development, Manufacturing, Engineering, Facilities, QC/QA, EH&S and IS in February 1999.