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PDA Parenterals Conference

From 26-28 October, 2010 the PDA Parenterals Conference will be held in Berlin.

This outstanding event will cover the very important topics:

  • Future of Parenterals
  • Packaging and Impact on Quality
  • Manufacturing Flexibility and Control
  • Innovative Plants
  • Monitoring Technologies
  • Medical and Application Devices
  • Regulatory Trends

Don´t miss this interesting conference in Berlin, Germany.

Brochure of PDA Parenterals Conference 2010, October 26-28

 

News about GMP/cGMP

Process Validation: EMA Concept Paper

EMA published some days ago the Concept Paper on the Revision of the Guideline on Process Validation. This concept paper aims to update the guideline on Process Validation; due to the development of new ICH guidelines Q8, Q9 and Q10, this guideline is being reviewed in order to implement the concepts highlighted in the ICH guidelines.

 

The current guideline does not reflect the recent regulatory developments on Process Analytical Technology (PAT), Quality by Design (QbD) and Real-Time Release Testing (RTRT).

Outcome:

Deadline for comments: May 31, 2010. For submitting your comments to QWP@ema.europa.eu, use the template linked with the Concept Paper!

Link:

EMA/ Announcement

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