Pharmaceutical Automation & Information Systems

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In association with

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Presents an Educational Opportunity
Sponsored by

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Pharmaceutical Automation & Information Systems

Date: October 22, 2013
GSK’s Upper Merion Campus
5:30-9:00pm (3 hour session)
A light dinner is provided prior to 6pm lecture.

Presenters include:

  • Shaun McWeeney, Johnson & Johnson (Principal Engr in Strategic Operations)
  • Mary VanHorn, Johnson & Johnson (Senior Mgr in Computer System Auditing Group)

Overview – Learn about the types of information and data management systems that are integral to successful drug development, manufacturing, and distribution as well as the controls and methods necessary to maintain data integrity and security. This session is also part of a series of DV ISPE Education courses this season that can help interested individuals study for getting their CPIP (Certified Pharmaceutical Industry Professional) certification. This is the first session in the series and is noted as Information Systems (Knowledge Element 3 of 7) in the CPIP study guide. Attendees need not participate in the entire program to attend any particular session. See DV ISPE website https://ispe-dvc.org/ for more details on the full program. Topics include:

Controls and Automation

  • Knowledge of building management systems.
  • Knowledge of types of process automation and associated controls.

Information systems

  • Knowledge of data management systems with product and financial. impact (for example, manufacturing execution systems [MES], laboratory information management systems [LIMS], electronic document management systems [EDMS], and enterprise resource planning [ERP]).
  • Knowledge of the basic computer system life cycle model and the activities and software quality assurance practices in each phase.
  • Knowledge of data integrity and security measures, such as back-up, archiving, and retention requirements.

Production Control

  • Knowledge of batch records
  • Knowledge of methods and tools for data manipulation and analysis
  • Knowledge of critical quality attributes and process controls

Price & Registration

  • Members (including ISA members): $50/session
  • Non-Members: $80/session
  • Students/Faculty: $10/session

PDH (Professional Development Hours)
Three (3) hour certificate given. Recognized for PA and NJ Professional Engineering ongoing educational requirements.

Please Register Now at this ISA_ISPE education system link:

Please contact DV ISPE’s Ron Dunn at 610-351-3874 or Rdgrafx@aol.com for alternative registration method.