Session Type: Recorded Webinars
Knowledge Element: Production Systems
Speaker: Dr. Kate McCormick, Consultant, Healthside Information Services, Ltd. UK 
Duration: 45 minutes

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Participants are presented with an overview of the key production systems. The presentation is divided into three main sections. First, there is a description of the main product types, both active pharmaceutical ingredients and finished dosage forms. Typical process flow charts are derived by the delegates.

Second, there is an overview of the main environmental systems, describing the heating ventilation and air conditioning (HVAC) requirements and monitoring parameters. Other utility systems including water and gases are briefly discussed. Typical HVAC layouts are developed by the delegates.

Finally, there is a section on warehousing and logistics. Both manual and automatic systems are presented together with security measures such as Radio Frequency Identification (RFID).

Learning Objectives:

• Discuss critically the production system requirements for specific types of products;
• Apply the requirements for production technology, environmental conditions and logistical security to their own manufacturing situations; and
• Develop a strategy for complying with the regulations.
  Personnel who should attend

Who Should Attend:

• Quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management 
• Entry-level personnel who need to develop an understanding of the European and U.S. regulations relating to production systems 
• Service organizations, suppliers, and vendors who serve pharmaceutical industry clients

Speaker Biography

Dr. Kate McCormick, of Healthside Information Services Ltd, UK, is a manufacturing consultant with extensive strategic and operational management experience in the pharmaceutical industry, both in the U.K. and internationally. McCormick has 10 years of line management and 20 years of internal and external consulting experience. She has worked with multinationals, SMEs, non-governmental organizations and national regulatory authorities in more than 50 countries. She is the author of Quality and Manufacturing in the Global Pharmaceuticals Industry (a textbook within the Butterworth Heinneman pharmaceutical engineering series), the editor of GMP Review and a regular speaker at international conferences. McCormick gained a degree in biochemistry and a doctorate in microbiology, both at London University. She also has a Masters in business administration and is registered as a senior GMP expert within the EU and is eligible as a QP under the terms of the EU directive.

What is a Recorded Webinar?

Previously held webinars are available as recorded sessions, which you can view at your convenience. Registration orders are processed within two business days, after which participants will receive an e-mail confirmation with a link to the Recorded Webinar. After receiving the link to the Recorded Webinar, you have 15 days to view it.

What are CPIP^SM Recorded Webinars?

CPIP^SM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry Professional^SM (CPIP^SM) examination..

The Certified Pharmaceutical Industry Professional^SM (CPIP^SM) credential recognizes “change agents” as the necessary ingredient to foster industry innovation and enhance drug product quality. The credential establishes a global competency standard for industry professionals, and candidates are assessed through demonstrated education, experience, and a rigorous examination. Completion of any of these seminars does not guarantee successful completion of the CPIP certification exam, and these seminars do not include every subject to the depth of what will be covered on the CPIP exam.

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