Pre Conference Day Workshop: 20th February 2012

14.00 - 17.00 Introductory Level PAT and QbD: Offering a Bite Sized Insight into the Evolving Quality Industry

Are you capitalizing on the benefits to quality and compliance that accrue from adopting robust quality systems? Adoption of the ICH Q10 model for a pharmaceutical quality system should facilitate innovation, continual improvement and strengthen the link between pharmaceutical development and manufacturing activities. Learn how QbD principles combined with PAT technologies will facilitate to implement a robust pharmaceutical quality system according to ICH Q10 in the development and in manufacturing and how it will enable you to gain the benefits of establishing and maintaining a state of control, continual improvement, enhancing regulatory compliance and meeting quality objectives. Your workshop leader, Founder of Industrial Lab Automation, Peter Boogaard, attended the ISPE International Society for Pharmaceutical Engineering, PDA FDA and EMA Pharmaceutical Quality conference and will be able to demonstrate several use cases.

Working closely with Peter, you will learn…

  • A practical introduction and update on ICH Q10 and QbD Pharmaceutical Quality Systems guideline
  • Industry examples of QbD and PAT implementations in both development and manufacturing
  • Introduction to the 4 Product Quality System elements
    • Process Performance & product Quality Monitoring System
    • Corrective Action & Preventive Action (CAPA)
    • Change management system
    • Management review
  • Introduction to quality system enablers such as knowledge management

Financial gains:

In development:

PAT will lead to more process knowledge. More knowledge results in better understanding, less product variations, higher quality prediction, more robust processes and because we have more knowledge , identifying products who will not make final investigation will be earlier in the life cycle. Major savings.

In production:

PAT will lead to faster release of batches, because no off-line (laboratory) testing will be needed. QbD scientific risk based approach will result in less testing, because we gain more knowledge in the different manufacturing stages. Batch release can change from days to hours.

Meet you workshop leader:

Peter Boogaard, founder of Industrial Lab Automation Consultancy, studied analytical chemistry in Delft (The Netherlands). Here he was introduced to computer software during his research on inductively couples plasma (ICP) technology, now a de-facto standard in many analytical analysis methods. Peter started his international professional career with Perkin-Elmer Corporation. Thanks to his first employer, who understood very early on, the importance of the end-user experience, he created many application programs to for fill the client needs. Peter has been able to adopt and expand this behaviour successfully with great companies including Applied Biosystems, Oracle, Informix, Symyx, Life Technology and LabVantage. Peter has published several white papers and contributes in industry advisory boards.

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