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Course Details

Delivering Against the Quality Agenda in Pharmaceutical Manufacturing

Newcastle University
Contact Provider
Newcastle upon Tyne
20 hours over 3 days
Short Course
Industrialists with an interest in all aspects of quality control and management
Room M413, 4th floor Merz Court, School of Chemical Engineering & Advanced Materials, Newcastle University, Newcastle upon Tyne, NE1 7RU, Tyne and Wear, United Kingdom

A manufacturing plant or process can be considered to be well managed when: 

  • All critical sources of variability are identified, explained, and controlled
  • Product quality attributes can be accurately and reliably predicted for a variety of settings within a predefined design space for manufacturing. 

At the beginning of this century the FDA recognised that the Pharmaceutical sector needed to learn from other high tech industries and modernise itself. In 2002 they announced a significant new initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century. This was a rallying call to the pharmaceutical industry to move away from traditional manufacturing paradigms such as after -the -fact specification setting and over emphasis of the first manufacturing batches and quality systems that rely only on testing and inspection. This revolution has gained momentum and many organisations in Pharmaceutical Manufacturing are starting to curb rising development costs and reduce regulatory barriers to innovation and creativity as they understand and deploy the principles and tools outlined in the FDA’s vision.


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