Production Systems: Production Unit Operations Drug (Small Molecule) and Biologics

Get current information on the manufacture of active pharmaceutical ingredients, components, and excipients, while gaining an understanding of unit, labeling and packaging operations. Review critical process equipment and utility system attributes (performance, functionality, construction, instrumentation) and their impact on personnel and product; controls required for the receipt, storage, and dispensing of raw and packaging materials; industrial engineering standards, facility and equipment utilization; and operational efficiencies. At the conclusion of this online course, participants will have knowledge of:

  • Manufacture of active pharmaceutical ingredients, components, and excipients
  • Unit operations
  • Labeling and packaging operations
  • Critical process equipment and utility systems’ attributes (performance, functionality, construction, instrumentation) and their impact on personnel and product
  • The controls required for the receipt, storage, and dispensing of raw materials, and packaging materials
  • Industrial engineering standards, facility and equipment utilization, and operational efficiencies

Attendance suggested for:

  • Years in industry: 0-4 to 5-14
  • Ideal audiences are those with 2+ years of industry experience that want to supplement their industry knowledge about a specific topic(s)
Kathleen Elizabeth McCormick
Writer/Publisher
Heathside Information Services Ltd. / ISPE

Dr Kate McCormick is a writer and manufacturing consultant with extensive management experience in the pharmaceutical industry. Kate has worked with multinationals, small and medium sized enterprises, non-governmental organizations (NGOs) and national regulatory authorities in more than 50 countries. Much of her work in the past twenty years has been in Central and Eastern Europe, particularly in Russia and the Former Soviet Union countries. Dr McCormick is the author of 'Quality' (a textbook within the Butterworth Heinemann pharmaceutical engineering series) and 'Manufacturing in the Global Pharmaceuticals Industry' and a former editor of gmp Review. She is an International Education Advisor for ISPE. Dr McCormick has a degree in biochemistry and a doctorate in microbiology, both from London University. She also has a Master in Business Administration from Cranfield University. She is registered as a senior GMP expert for the purposes of EU-funded projects and is eligible to act as a QP under the terms of the EU directive.

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