Developing a secure in-house strategy for PAT and QbD application for biopharmaceutical products

Pharma IQ is delighted to announce the inaugural PAT and Quality by Design for Biopharmaceuticals, being held in London on the 25th-26th May 2010. Now well established within the small molecules field and the PAT and QbD are being incorporated into the large molecule arena. With key regulatory bodies such as the FDA and EMEA actively getting involved in pilot schemes the time has never been more prudent to ensure you have the correct application strategy in place.

This event will bring together professionals specifically tasked with implementing PAT and QbD, delivering a unique opportunity to discuss case studies, key challenges that are currently being faced and devise new solutions.

Key Topics to be Discussed:

  • Improve product quality for the patient by refining your legacy product processes through retrospective Quality by Design: Merck Serono discuss how they have improved the production process of one of their best selling products
  • Establishing best practice approach in setting a secure design space for biopharmaceutical products: Sandoz and Pfizer discuss the methods used and how to overcome the challenges you will face
  • Assessing the best practical approaches to applying Quality by Design in your business: Learn from key case studies delivered by Merck Serono, CMC Biologics Agenda day one) and Pfizer how to best apply Quality by Design
  • Successfully applying Risk Assessment and Management tools when Implementation of Quality by Design (QbD): The Indian Institute of Technology discuss how bet to mitigate and manage the risks

Here is what attendees have said about our sister PAT and QbD event:

Very valuable-have learned a lot.
- Martin Eaves, Abbott Laboratories
Great forum for networking, exchange views and learning.
- Barry Gujral, Noven Pharmaceuticals Inc.
Very useful.
- Martin Warman, Vortex

Gain Crucial Insights From Leading Professionals Including:

Pascal Valax
Group Manager, Biotech Process Sciences, Downstream Processing
Merck Serono S.A

Dr Jens Gram
Director, Project Science
CMC Biologics A/S

Professor Anurag Rathore
Department of Chemical Engineering
Indian Institute of Technology

Dr Stephan Ward
Director of Development
Stabilitech

Featured Exhibitors: Platinum Partner
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Media Partners
_Media Partners

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