Automation and Controls

Session Type: Recorded Webinars
Knowledge Element: Facilities and Equipment
Duration: 55 minutes
Speaker: John Andrews, Director, Andrews Consulting Enterprises, Ltd. 

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Good Manufacturing Practice (GMP) states that automation may be used in the manufacture, processing, packing, and holding of a drug product. However these systems should be properly specified, designed, and tested (validated). They also must be adequately monitored and maintained and people involved in the maintenance and use of these systems must be adequately trained, with records of that training kept.

This webinar provides an overview of the different types of automation available, investigates opportunities for automation within manufacturing, and discusses relevant regulatory requirements. It also looks a little deeper at the must commonly used control system type, the Programmable Logic Controller (PLC) and the validation and management of such systems.

The most difficult systems to validate and manage, including issues and how to best manage them, are reviewed.

Participants will learn the varying options for process automation, as well as the issues related to their development, verification and validation.

Learning Objectives:

• Understand the different types of control systems (PID, PLC, SCADA, DCS, etc.)
• Investigate areas for automation within a typical process 
• Clarify the regulatory requirements associated with automation (using both the US CFRs and the EU Orange Guide) 
• Discuss the architecture and principle operation of a PLC 
• Review the different types of PLC programming 
• Review the principles for the development and validation of all control systems 
• Obtain an understanding for the types of procedural controls and maintenance aspects necessary to ensure continued compliance of these systems 
• Review the typical BMS concerns 
• Discuss the regulatory position on BMS 
• Understand how a BMS should be managed 
• Investigate the options available to bring a legacy BMS into compliance

Who Should Attend:

• Professionals who are responsible for the implementation and management of process automation 
• Suppliers and others involved in process automation, such as quality assurance and quality control specialists, validation scientists, manufacturing supervisors, technical support personnel, engineers, and all levels of management

Speaker Biography

John Andrews is a Director of Andrews Consulting Enterprises, Ltd. His responsibilities include providing consultancy on computer systems validation, compliance and quality assurance activities within the pharmaceutical, biopharmaceutical, medical device, and other regulated healthcare industries. Andrews is a member of the ISPE GAMP® 4 Special Interest Group on Process Control, and he also sat on the editorial board for GAMP 4. He currently specializes in the application of GAMP principles to the validation of PAT technologies. Previously, Andrews was the manager of IT Consulting Service at KMI, a division of PAREXEL International LLC. He also served as computer system validation manager and supply chain systems project manager with GlaxoSmithKline (GSK). Responsibilities at GSK included all aspects of computer systems validation, from process control to business and laboratory system validation. He managed teams with responsibilities for ensuring that all computer system validation activities undertaken on site and within projects were completed to an appropriate level of compliance with the regulations. In addition, Andrews served 15 years with SmithKline Beecham Pharmaceuticals where he held positions as a senior engineering standards engineer, secondary manufacturing electrical engineer, projects engineer, and electrical supervisor.

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 email 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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