Pharmaceutical Quality Assurance and Control
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Who Should Attend
This intensive course will benefit those who need to
understand the responsibilities and functions of the Quality
Unit in a pharmaceutical firm and 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:
• Research &Development
• Process Development
• Analytical Development
• Quality Assurance
• Quality Control
• 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. The material also applies 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, the impact of management
practices, the features of an effective quality organization,
quality management throughout the product life cycle –
including GMPs 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.
Other Courses of Interest
Active Pharmaceutical Ingredients
May 21 2012, New Brunswick, NJ
Active Pharmaceutical Ingredients
Jun 27 2012, Amsterdam, The Netherlands
Analytical Methods Validation for FDA Compliance
Mar 07 2012, Burlingame, CA
Auditing for GMP Compliance
Mar 27 2012, Amsterdam, The Netherlands
Calibration in the FDA Regulated Industry
CGMPs In-Depth Analysis for Pharmaceutical Life Cycle Management
May 08 2012, New Brunswick, NJ
CGMPs In-Depth Analysis for Pharmaceutical Life Cycle Management
Jun 18 2012, Amsterdam, The Netherlands
Conducting Effective Quality Audits
ICH Q10: Pharmaceutical Quality System
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