Operation Maintenance

Session Type: Recorded Webinars
Knowledge Element: Facilities and Equipment
Speaker: Bob Lennon, Principal Engineer, Commissioning Agents, Inc. 
Duration: 30 minutes

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The Code of Federal Regulations (CFRs) states equipment that is used in the manufacture, processing, packing, and holding of a drug product shall be routinely calibrated, inspected or checked according to a written program. However, these facilities and equipment must be properly cleaned and maintained, and such activities must be adequately monitored, and people involved in the maintenance and use of these systems must be adequately trained, with training documented.

This Webinar provides an overview of the different regulatory concepts, drivers and requirements, equipment design parameters, as well as operation control and maintenance plans available. It investigates opportunities for cost control within manufacturing and maintenance, and discusses the relevant improvement tools. It also looks a little deeper at the most used analysis techniques for risk assessments and mitigation (FMEA) and discusses the strategies, use and management of these systems.

This Webinar also looks further into the importance and analysis of equipment failures and the types of systems strategies and plans to manage failure in operations and maintenance, and looks at what the issues are and how these should best be managed.

Participants will learn to understand the various options for assessing operation and maintenance strategies, as well as the issues and planning needs relating to their development, verification and validation.

Learning Objectives:

• Understand the different types of management tools (FMEA, RCM, TPM, Etc.) 
• Investigate the areas for risk assessment within a typical process 
• Clarify the regulatory requirements associated with operations and maintenance (using the US CFRs) 
• Discuss the principle of failure analysis as it relates to design space and risk mitigation 
• Review the different types of documentation required for regulatory compliance 
• Review the principles for optimization of process equipment and maintenance 
• Obtain an understanding for the types of strategies for process operations and maintenance that are necessary to ensure continued compliance 
• Review the typical RCM concerns 
• Discuss the regulatory position for continuous improvement 
• Understand how product development science and design space should be managed to reduce and mitigate operations and maintenance product risk 
• Investigate the options available to reduce the costs of a maintenance program

Who Should Attend:

• Professionals who are responsible for the implementation and management of facilities, operations and maintenance
• Suppliers and others who are involved in operations, maintenance, equipment, facilities and commissioning and qualification such as quality assurance and quality control specialists, validation, manufacturing supervisors, technical support personnel, engineers, and all levels of management

Speaker Biography

Robert Lennon is Principal Engineer for Commissioning Agents, Inc. He has held positions as president of a bulk materials equipment engineering and manufacturing company, and vice president of engineering and manufacturing for a plastics compounding company. His experience also includes industrial engineering and project engineering assignments in aerospace engineering and manufacturing, and in plant and maintenance engineering. Lennon has also had management assignments in production operations and plant management, procurement/purchasing, and research and development. He holds several U.S. patents for engineering materials delivery systems. His professional memberships include ISPE, SME (Society Manufacturing Engineers), and SPE (Society of Plastics Engineers). Lennon holds a mechanical engineering degree from Temple University, an MS in industrial engineering, and an MBA from Rockhurst University.

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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