Pharmaceutical Quality Assurance and Control
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Who Should Attend
This 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
- Purchasing
- QA
- Engineering
- QC
- Maintenance
- Regulatory Affairs
- Corporate/Plant
- Plant Operations Management
The course will also benefit personnel in Regulatory Agencies
and Suppliers to the Industry
Description
This course provides an understanding of the principles and
practice of pharmaceutical quality assurance and control and
of specific topics which have become important because of
regulatory interest or recent technological achievements.
Throughout the course an emphasis is placed upon quality as
viewed on a cost/benefit basis as well as a cGMP basis.
The first day provides an understanding of the basic principles
and practice of the QA and QC functions, covering their role
during product design, production and revision, with the role
in production being dealt with in particular detail. The second,
third and fourth days consist of reviews, first of broad current
quality issues including FDA activities, and then the QA/QC
aspects of a number of specific issues including: handling of
laboratory controls, validation (equipment, processes,
computers, cleaning and test methods), label and labeling,
water systems, change control, electronic records and
signatures, deviations and discrepancies, (including OOSs),
FDA inspections, internal and supplier audits, vendor and
contract supplier qualification, annual product reviews, and
training. A general question and answer session is also
provided. The fifth day is devoted to the QA/QC aspects of
stability program operation and also to documentation. The
course includes hands-on workshops as well as lectures.