Conference Description:

The Pharmaceutical and Biotech industries are going through tremendous changes that have been increased by the recent global financial challenges. The FDA is promoting the use of Quality-by-Design (QbD) as an approach for helping companies speed up development and improve their operations. In addition the FDAs new Process Validation Guidance promotes Continued Process Verification. Sampling is an essential element of both process and product development and continued process verification.

Areas Covered in the Session :

>. Principles for developing useful sampling plans and procedures
>. When “Square Root (n)+1” is a valid sampling plan
>. Creating a process sampling system using ANSI Z1.4 Sampling Plans
>. Sampling plans for monitoring process stability and capability
>. Practical power calculation procedures for determining appropriate experiment size
>. Plans for sampling tanks and blenders

Who Should Attend:

>. Department Managers
>. Quality Engineers
>. Research and Development Scientists
>. Biologists and Microbiologists
>. Process and Manufacturing Engineers
>. Quality Assurance Personnel
>. Executives
>. Supply Chain Professionals
>. Accounting Professionals