The Center for Professional Advancement, New Brunswick, NJ
October 15-19, 2007
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.
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