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Paperless Systems, Lessons Learned

Bristol-Myers Squibb
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!

SCHEDULE
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


EVENT INFORMATION:

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 this event.


PROGRAM SUMMARY:

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 Learned

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 company size. 

SPEAKER:

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.

SPEAKER:

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.


COST:
Early bird, register by 2/08/18
Members - $50
YP Members - $20
Nonmembers - $95
Student Members - FREE

After 2/08/18 
Members -  $60
YP Members -  $30
Nonmembers - $115
Student Members - FREE

Meeting Mangers:
Janelle Carretero, New England Controls
John Sheridan, PMA Consultants
Kevin Keating, Massachusetts Biologic Laboratories


Thank you to our sponsor:

CAI Commissioning Agents, Inc.

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Event Date: 2018-02-15 17:30:00 — 2018-02-15 21:00:00
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(Early-Bird Non-Member Rate)
Early-Bird rate available through Thursday, February 08, 2018

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Cancellation Policy

You may cancel without penalty or receive a refund if your cancellation is made in writing via mail, fax or e-mail to the ISPE Boston Area Chapter Office (465 Waverley Oaks Road, Suite 421, Waltham, MA 02452; office@ispeboston.org; Fax: 781-647-7222) and received prior to one week before the event. Refunds will not be made for cancellations after that date.

Refunds will be processed within 30 days after the written cancellation is received at the ISPE office. Registrations are transferable and may be switched to the name of someone else from your organization that is able to attend. Please call or email the Office with the other attendee's name.

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ISPE Boston Area Chapter
465 Waverley Oaks Road, Suite 421
Waltham, MA 02452
Phone: (781) 647-4773
Email: office@ispeboston.org

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