Pharmaceutical Quality Assurance and Control
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Who Should Attend
This intensive course will benefit those who need to know
how quality can be assured and controlled in the production
of pharmaceuticals and related products. The material is
particularly suitable for chemists, pharmacists, engineers
and administrators working in the following areas:
• R&D
• Process Development
• Analytical Development
• QA/QC
• Regulatory Affairs
• Plant Operations
• Purchasing
• Engineering/Maintenance
• Corporate/Plant Management
The course will also benefit personnel in Regulatory Agencies
and suppliers to the industry.
Description
This course provides the basic principles and practices of
quality assurance and control (as functions and departments in
the pharmaceutical industry) with much of the material applying
to the biopharmaceutical, diagnostic, device and cosmetic
industries and to suppliers, including API manufacturers. The
discussions include the role of quality and the major elements
of pharmaceutical quality such as customer, consumer,
regulatory & industry viewpoints, the impact of management
practices, the features of an effective quality organization, what
quality aspects need to be managed throughout the product life
cycle – including GMP compliance - and the role of corporate
quality. The course discusses current quality issues including
company reorganizations, outsourcing, the evolution of FDA
approaches, global standards by such organizations as ICH
and IPEC and the use of such techniques as risk management,
QbD and the Quality System approach. Throughout, an
emphasis is placed on the need to achieve quality at optimum
cost. The course includes an interactive question/answer
session.