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June 11, 2009

Issue Highlights
- How’s Your Rapid Micro Business Case?
- Ciurczak: Beam Our Data Down
- Neway, Chatterjee on Validation Guidance: Use as Directed

Ensuring ROI from Your RMM
If you’re heading towards the adoption of rapid microbial methods, you’ve got to be able to make a business case. Rapid micro expert Michael J. Miller, Ph.D., presents a detailed case study on how one company more than justified its RMM investments.

Beam Me Some Data, Scotty!
If satellites can track Pacific tsunamis and Alaskan dogsleds, why not counterfeit drugs as well? Emil Ciurczak looks towards the heavens for inspiration.

Process Validation Guidance Calls for Technology Solutions
The draft guidance is a win-win-win: good for FDA, consumers, and manufacturers. But you’ve got to have the right software, says Justin O. Neway, Ph.D., Aegis Analytical Corp.

Process Validation Guidance: Worthy of Embrace
Those who embrace the new process validation guidance may separate themselves from those who do not. Bikash Chatterjee of Pharmatech Associates explains.

White Paper: Tackling the Challenges of Pharmaceutical Manufacturing Productivity
Pharmaceutical manufacturing operations are complex, inefficient and consequently costly. This white paper explores the tools in the PAT framework, and shows how an appropriate combination of these tools may be applicable to a single-unit operation, or an entire manufacturing process in its quality assurance.

Webinar: Best Practice Business Solutions for the Life Sciences
When: Tuesday, June 30, 2009 11:00 AM Eastern
In this webinar, Idhasoft, an SAP Gold Partner for Life Sciences, will demonstrate how its Pharmaceutical Solution helps you:

  • Get visibility across your entire business
  • Institutionalize compliance
  • Embrace operational excellence from supplier to customer
  • Innovate with partners worldwide to accelerate development
  • Take advantage of the Idhasoft ePedigree Solution for SAP, the most widely adopted electronic pedigree software across the pharmaceutical supply chain

Click here to register.

PAT News and Opinion

10 Data Mining Mistakes to Avoid

PAT, QbD Engineering Pharma’s Slow Turn

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