Process Analytical Technology (PAT)
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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.