Role of Pharmaceutical QA/QC in Quality Systems
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Who Should Attend
This course will benefit those who need to know how quality
assurance and control are involved in the design, implementation,
operation and management of the Quality System for
pharmaceuticals and related products, particularly via its
responsibilities for the component quality systems. The material
is particularly suitable for chemists, pharmacists, engineers and
administrators working in the following areas:
• R&D
• Plant Operations
• Process Development
• Purchasing
• Analytical Development
• Engineering/Maintenance
• QA and QC
• Corporate/Plant Management
• Regulatory Affairs
The course will also benefit personnel in Regulatory Agencies and
Suppliers to the Industry.
Description
Current thinking in the pharmaceutical and related industries
is that companies should have a Quality System and that the
System should comprise of component systems such as the
change control system or the deviation system. Many of these
systems interact and their management needs to be coordinated.
This coordination has become the responsibility of QA/QC.
This course discusses this involvement for those systems which
are of particular interest for technological reasons or because
they have become a focus of FDA concern. They include those
concerned with production, material release, training, laboratory
controls, water, label/labeling, validation/qualification, deviations/
discrepancies, CAPA, change control, documentation, supplies,
stability, auditing and product reviews. In discussing these
systems, an emphasis is placed on the need to achieve quality at
optimum cost. Much of the material discussed applies to related
industries such as the biopharmaceutical, diagnostic, device
and cosmetic industries and to suppliers particularly API
manufacturers. The course includes an interactive question/
answer session.