38 Jackson Road
Devens, MA 01424
Please note that due to BMS security protocol, walk-ins will not be accepted onsite.
Register to reserve your spot!
Registration opens at 5:00 PM - we recommend arriving early for security check-in.
5:30 - 6:30: Registration & Networking Reception
6:30 - 6:40: Introductions
6:40 - 7:10: Virtual Tour of BMS Facility
7:10 - 8:30: Speakers Presentations
8:30 - 9:00: Q&A
Dealing with too much paper and
looking for a better way to manage it? Join ISPE Boston Chapter for an evening
at BMS. Gain knowledge about digitization of paper processes from two
perspectives - a performance consultant's expertise, and an end user's
experience. Enjoy complimentary hors d'oeuvres and a virtual tour of BMS prior to
the presentation. Register TODAY for
Changing to a new software program is
the easy part, but implementing a paperless validation system serves as more of
a challenge. At this program, hear first-hand accounts from both a
commissioning agent and owner to understand how the implementation can be
effective - from the "why," to the implementation, to the organization, and how the
transition ultimately benefits the whole team. This session will cover both a
case study and the experience of a pharmaceutical company who lived it.
Register to attend today and take advantage of the lessons they learned.
WHO SHOULD ATTEND:
Anyone dealing with volumes of
documents and cumbersome paper flow processes should be here. Everyone who
works in automation, IT, quality, process engineering, and operations should be
interested in this session. All are welcome!
PART 1: Lessons
Pharmaceutical companies are driven by one primary mission - to
increase the quality of patients' lives through technology and innovation. BMS
Devens started with digitized manufacturing and laboratory processes to
increase efficiency, elevate the level of regulatory compliance, and achieve
operational goals. A representative from BMS, the industry leader in the
digital movement, will present the company's lessons learned as they embarked
on their digital journey with paperless vision since 2006. The presentation
will cover topics from realization of paperless vision to the knowledge gained
through experience, making it a valuable discussion for individuals in any
Nancy Poirier, Associate Director,
Manufacturing Engineering, Bristol-Myers Squibb Company
Nancy has been with Bristol-Myers
Squibb for 8 years, beginning her tenure as a Manufacturing Engineering
contractor responsible for start-up activities. In 2013, she converted to a
full-time employee and has been in her current position for the past three and
a half years. Prior to working at BMS, Nancy worked as a senior engineer at CRC
Consulting and GlaxoSmithKline (formerly ID Biomedical), and working as an
engineer on the floor for Wyeth BioPharma. She graduated from Tufts University
with an MS in Chemical Engineering and BA in Chemistry from Lake Forest College.
PART 2: Benefits Electronic Validation Lifecycle Management (eVLM) systems: A Case Study
Electronic Validation Lifecycle Management (eVLM) systems have begun to disrupt traditional document-based validation processes. eVLM systems are designed to create value for companies that manufacture biopharma products and medical devices by helping these companies improve quality, reduce cost and manage risk.
This presentation will provide an in-depth case study of how a eVLM system was employed to assist an emerging biotech firm design and validate a new manufacturing facility. We will look at the goals that motivated the company to adopt a paperless validation system, compare/contrast the paperless and paper-based systems for each of the major steps in the validation process, and we will assess how the paperless validation system measured up against the company's goals. We will wrap up by sharing lessons learned from companies who have adopted paperless validation systems, and a guide to help you assess if a paperless validation system would be a good fit for your company.
This presentation will be of particular interest to managers, engineers and analysts responsible to plan, build, commission and operate facilities for the manufacturing pharmaceuticals and medical devices - particularly in the areas of quality validation, quality assurance, procurement, information systems, design engineers and capital project managers - as well as consultants who support these activities.
Charlie Maher, Executive Director, Performance and Reliability, Commissioning Agents, Inc.
Charlie Maher is the Managing Director of BioVoke with overall responsibility for product development and commercial growth. Charlie has led large, complex C&Q projects for Commissioning Agents, Inc. and has experience in business development for SaaS products. Charlie previously served in the submarine force of the United States Navy where he commanded a nuclear-powered submarine and served as the Chief of Staff of the Naval Undersea Warfare Center, the Navy's R&D facility for undersea weapon systems. Charlie has graduated with an MBA from the Sloan School of Management, a MA in National Defense & Strategic Studies from the Naval War College, as well as a BS in Physics and a BA in History from the University of Notre Dame.
Early bird, register by 2/08/18
Members - $50
YP Members - $20
Nonmembers - $95
Student Members - FREE
Members - $60
YP Members -
Nonmembers - $115
Student Members - FREE
Carretero, New England
Sheridan, PMA Consultants
Thank you to our sponsor:
CAI Commissioning Agents, Inc.