Role of PAT and QbD in Biologic Drug Production
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Who Should Attend
This comprehensive quality system workshop will benefit
professionals who are involved in the entire biologic drug
chain, from development, through unit operations to product
fill, storage and release to market, including:-
PAT and QbD Team Leaders and Members
- Quality and Efficiency Personnel
- Manufacturing Operations Personnel
- Product Development Teams
- Technology Transfer Personnel
- In-process and Finished Goods Analysts
- Biologic Excipient Suppliers
- Analytical Instrument and Manufacturing Equipment Suppliers
- Managers tasked with biologic product development and evolution
Description
PAT – Process Analytical Technology is a risk management
approach for ensuring consistent production of prescription
drugs within a well-defined quality envelope. QbD – Quality
by Design – encompasses PAT and uses its concepts across
a much wider front; from drug discovery and development to
the patient. Both PAT and QbD are mainstays of 21st
century good manufacturing practice.
This course establishes an operating baseline for biologic PAT
programs, using the outcomes of successful small-molecule
PAT efforts. Course modules include an analysis of biologic
business drivers and timelines, PAT and QbD principles and
their relationship to the ICH – International Conference on
Harmonization.
The course includes sections on biologic unit operations,
in-process testing and supra-process testing - including the
use of dynamic test technologies to support mainstream
production methods.