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Date: 18th February, 2010

Location: On-Line, North America

Summary:
Pharmaceutical - Web Seminar

Click here to Register for this Seminar

Microbiological Rapid Methods (RMM) are being considered in today’s testing facilities as an opportunity to expedite the testing and release of raw materials, in-process analyses, API and final products. While materials and in-process analyses may readily benefit from rapid methods where presence or absence of growth, as well as 'a less than' number is the desired end result, the number of rapid methods available for sterility testing are more limited.

This live and interactive BenAstrum web training course will explore issues to include:
How will RMM benefit my organization?
How much time will my organization save?
Will RMM expedite the release of 'a test' result?
Does my organization require faster release?
What does each new test cost vs. my old method (personnel and materials)?
Does the assay application work for my organization?
Do other organizational limitations exist that will supplant this faster release?

This course will also consider the role of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), as well as the ultimate Method Validation of the proposed equipment. It will include discussion surrounding how to evaluate the demonstration of a vendor’s microbiological testing that may be incorporated into an OQ or PQ.

The objective of this training is to explore how RMM may benefit your organization, whether they are cost effective within your organization, and will the RMM provide for faster release of materials, in-process tests and final product, while assuring your Company is maintaining itself within GMP compliance.

Discussion Points:

• The 'how, what, when, why and where' of RMM
  


• The role of DQ, IQ, OQ and PQ within the purchase of a RMM
  


• The role of a Method Validation in utilizing a new method
  


• Comparability issues
  


• Case studies involving RMM
  

Determination of Microbiological Rapid Method Requirements – Is There A Place for Them in Your Facilities?- Webinar