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I joined ISPE with the hope of giving something back to an industry that has served me well over the last 15 years. After attending one conference, I knew I wanted to become an active Member in the organisation. I wanted to have a role in ISPE activities and events that benefited other industry Members. I found the transition from attendee to active Member relatively easy. Despite the fact that ISPE is a society made up of volunteers, passion and professionalism in which business was conducted was eye opening. In my 10 years as a Member, I have made many friends who have afforded me the benefit of their experience within OUR industry and have changed both my professional and social view point. ISPE is a wonderful organisation and I hope to be part of it for years to come.

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Thermal Transfer, Ltd., United Kingdom

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Recorded Webinars

Design and Construction / Installation

Session Type: Recorded Webinars
Knowledge Element: Facilities and Equipment
Speaker: Andy Signore, PE, PMP, CPIP, DBIA, Co-founder and CEO of Integrated Project Services (IPS)
Duration: 60 minutes

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Facilities and equipment systems are specifically addressed by worldwide regulators, including FDA, EU and others as a major compliance components of Good Manufacturing Practices (GMPs). The cost to design/build/commission/qualify/own and operate pharma manufacturing facilities is a significant component of business execution within the pharmaceutical industry. GMPs evolve in scope and philosophy and demand constant vigilance to interpret and comply, especially as GMPs involve the procurement and installation of modern pharmaceutical equipment and facilities construction. The high costs to comply and/or recover from regulatory citations of product recalls is also a significant business issue and needs to be fully understood by the project professional.

Webinar content includes review of the role and impact of GMPs on design/construction and installation issues. Key design concepts are presented for critical equipment and utility systems as well as requirements for product protection, containment, environmental, safety and personnel protection. Good flows of people and materials, and their implication for layouts, are reviewed and prevalent materials, methods of construction, equipment and facilities, regarding cleanliness, functionality and maintainability are also addressed. Further, critical process equipment/utility system attributes for performance, functionality and their impact on personnel and product are covered as well as an overview of cleaning systems, CIP/SIP, and the fundamentals of Good Engineering Practices (GEP).

Learning Objectives:

  • Appreciate key regulatory drivers for facility and equipment construction and installation decisions 
  • Understand critical links between regulatory and business drivers for cost/schedule quality and performance of facilities and equipment as they form a central part of the pharmaceutical manufacturing program 
  • Understand the challenges of facility delivery in the pharmaceutical industry 
  • Identify risks and quality management approaches which lead to superior facilities design and operation 
  • Appreciate GMPs as well as Good Engineering Practices as tools for promoting excellent quality and risk management for manufacturing practices 
  • Improve teamwork, communication and effective project conceptual development and delivery through a deeper understanding of the multi-faceted challenges facing the professional designer and facility operator 
  • Distinguish between the different types of manufacturing facilities and their challenges for OSD, sterile and biopharmaceutical programs 
  • Apply Good Engineering Practices and apply them to daily practice 
  • Identify scope development challenges and establish functional requirements for new facilities which effectively drive design and construction as well as equipment specifications for new manufacturing facilities 
  • Understand integration issues of modern equipment and systems within facilities 
  • Understand global variations and distinctions of global regulators and the challenges to design and build facilities intended to source products to the global marketplace

Who Should Attend:

  • Professionals who are responsible for planning, designing, specifying, constructing, owning and operating modern pharmaceutical facilities 
  • Individuals who contribute as team members to capital facility programs and function in areas such as engineering, maintenance, quality control, quality assurance, regulatory affairs, project management, construction and validation 
  • Suppliers who provide materials, equipment and integrated systems to the global pharmaceutical manufacturing industry

Speaker Biography

Andrew A. Signore, PE, PMP, DBIA, CPIP, is Co-Founder and CEO of Integrated Project Services (IPS). Founded in 1989, IPS provides engineering and project delivery services focused on healthcare/pharma facilities. He has held engineering positions at SmithKline (now GlaxoSmithKline), Pfizer, and Merck. Signore earned his BSChE from Manhattan College and a MBA from Pace University. He is a registered professional engineer in Pennsylvania, New York, Ohio, New Jersey, Delaware and North Carolina. Signore was inaugural president of Design Build Institute of America’s Delaware Valley Chapter and is a charter holder of a DBIA designation. Signore is also past president of the New Jersey Chapter of Project Management Institute (PMI). In addition, Signore is past national chairman of the International Society for Pharmaceutical Engineering (ISPE), and past president of ISPE Delaware Valley Chapter, and a frequent course leader. Signore has earned Certified Pharmaceutical Industry Professional (CPIP) status from ISPE and has received ISPE’s Distinguished Achievement Award for his many professional contributions to the Society. 

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 CPIPSM Recorded Webinars?

CPIPSM Recorded Webinars are a group of Recorded Webinarswas developed to help individuals in preparation for the Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) examination..

The Certified Pharmaceutical Industry ProfessionalSM (CPIPSM) 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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