The Center for Professional Advancement, Amsterdam
24-26 October 2007
Who Should Attend:
This comprehensive PAT workshop will benefit professionals who are involved in the development, testing and production of pharmaceutical, OTC, fermentation and biopharmaceutical products, including:PAT Team Leaders
Analytical Managers
Pharmaceutical QA Personnel
Dosage
Instrument makers
Manufacturing Operations Personnel
Formulators
Excipient suppliers
Industrial Pharmacists
Managers tasked with improving the pharmaceutical business climate
Description:
Both the US Food and Drug Administration and the European Medicines Agency are pushing improvements in pharmaceutical manufacturing efficiency, defined as Process Analytical Technology, or PAT. These initiatives are driven by increased regulatory demand, consumer pressure and soaring drug dosage costs. The regulatory agencies have identified the test-to-document requirements of the old cGMP mandates as root causes for poor efficiency. This course establishes a baseline view of pharmaceutical manufacturing and examines PAT from industrial, regulatory and consumer viewpoints. Using case studies, the program demonstrates strategies that help management acceptance and support of PAT programs and provides tactics to avoid pitfalls. Detailed guidelines for PAT Team formation and management include a five-step plan with milestones. PAT laboratory and testing workflow, with reference to in-process monitoring will help participants transit from theory to practice. Several instrument and sensor segments help form a PAT toolbox, as does a review of chemometrics and statistical analysis. These segments are followed by a PAT validation unit. At the conclusion of the course, all participants will have a solid grounding in PAT program implementation.
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