ISPE Chapter Excellence and Annual New Year's Celebration Social Date: 10 January 2013
Pre-registration is closed. Walk-ins will be accepted on-site.
In early November at the ISPE Annual Meeting in San Francisco, the Boston Area Chapter was awarded the top honor, the North American/South American Affiliate Council "Platinum Grand Award for Excellence and Innovation" for the fourth year in a row!Thank you to the entire 2011-2012 Board of Directors, Committee Chairs and Volunteers for their commitment to the Chapter and their extraordinary efforts.
Join your friends and colleagues for ice skating, live music, and celebrating! Thursday, January 10th at the Kendall Square Ice Skating Rink at 650 East Kendall Street.
The event is FREE for Members and $20 for Non-Members.
ISPE Building Information Modeling (BIM): From Concept to Substantial Completion (and Beyond) Date: 17 January 2013
Pre-registration is closed. Walk-ins will be accepted on-site.
PROGRAM SUMMARY:
There continues to be a great deal of conversation around the topic of building information modeling (BIM) in the design, construction, and facilities management worlds. For designers, BIM offers the opportunity to engage with users in real time to reflect design decisions of lab spaces. Modifying the model during the user meetings, designers and lab users get it right during the design process in lieu of understanding the concept at move-in. BIM also presents new opportunities for streamlining the facilities management process once construction is complete. Using the data in the model allows facilities managers the opportunity to better control space allocations and tracking, evaluate move management and control equipment management. Attendees will understand the realized benefits of an effective BIM implementation (not just in concept but $ and time) with the help of virtual models and a tour.
In the first presentation, HDR will touch on a number of the projects for which BIM was leveraged, as well as present a real-world case study. These real world case studies leveraged BIM to improve the design process, expedite user sign-off, and enhance facilities management capabilities, all making the facility manager’s life easier. The second presentation will be given by the ASC Project Team (UMMS, SCCI, PMA and ARC) who just finished building the showcase project next door. To continue to build on its strengths in medical research and advanced therapeutics and stem cell development, the University of Massachusetts Medical School (UMMS) is creating an interdisciplinary, state of the art research facility designed to encourage interaction and collaboration among researchers and promotes innovation and synergies across disciplines. Under this UMMS Program are three projects totaling $440M that were constructed under the direction of the University of Massachusetts Building Authority (UMBA).
For the University’s 500,000 square-foot Albert Sherman Center (ASC) project, the team has created an intelligent BIM model. The final deliverable will be a model that provides MEP engineering intelligence for future renovations as well as ongoing facilities maintenance with a full online project database which includes O&M’s, Commissioning data, plans, specifications and beyond. The team is also exploring links with the Building Management System (BMS) as well as the computerized maintenance management system (CMMS). When complete, this model may become the basis for BIM usage for the entire UMass system. The Albert Sherman Center will accommodate 300,000 ft2 of space for wet research laboratories, cold rooms, and core research space; and 200,000 ft2 of dry research and educational space, including teaching areas, a 360-seat auditorium, conference center, cafe, fitness center, and support staff spaces. Substantial Completion will be in December 2012 and researchers moving in Spring of 2013.
SPEAKERS:
Brian Sykes, AIA, Architect and Project Manager, HDR Architectures (Bethesda, MD Office) Brian Sykes, AIAis an architect and project manager with HDR Architecture’s Bethesda, Maryland office. He is focused on leveraging BIM during the design of Science and Technology projects. Before joining HDR, Brian was a BIM Consultant at AEC Infosystems in Baltimore, Maryland, where he focused on support and modeling of federal facilities and BIM implementation at architecture firms across the Mid-Atlantic. Brian earned a Bachelor of Science in Architecture from Clemson University and a Master of Architect from Virginia Tech’s Washington Alexandria Architecture Consortium. He is an adjunct faculty member at Virginia Tech’s WAAC where he teaches sustainability and building technology. Brian is a member of the American Institute of Architects (AIA) and the Washington, DC Building Enclosure Counsel.
John Baker, Associate Vice Chancellor of Facility Management Partner, UMass Medical School John Baker is the Associate Vice Chancellor for Facility Management at the UMass Medical School, Worcester, MA. He has been in this position for the last ten years and prior to UMass, John served in the U.S. Navy’s Civil Engineer Corps, retiring after twenty years’ service. John earned a Bachelor of Science in Civil Engineering from the University of New Hampshire and a Masters of Science in Construction Engineering and Management from Purdue University. John is a registered professional engineer in New Hampshire and Massachusetts.
Tom Watson, Regional BIM/VDC Director, Suffolk Construction Company Tom Watson brings 20 years of industry experience as a Mechanical Engineer specializing in mechanical, electrical, and plumbing/fire protection (MEP/FP) on projects spanning the healthcare, education, and commercial market sectors. The majority of his career was spent working as a plumbing and fire protection engineer at Symmes, Maini & McKee Associates, focusing on the engineering design of schools, healthcare, and research facilities.
As one of the regional BIM/VDC Directors at Suffolk, Tom is responsible for developing and maintaining Building Information Modeling (BIM)/Virtual Design and Construction (VDC) processes for all projects. He utilizes 3D modeling for all MEP/ FP systems, identifying potential collisions, clashes, and constructability issues; provides 4D scheduling simulations of construction sequences; supports estimating in extracting quantities from the models (5D); and develops customized 6D Facilities Management solutions to support an owner’s life cycle management of a building.
Erik Servies, AIA, Associate, PMA Consultants Erik Servies, AIA is an Associate with PMA Consultants and has been providing Owner’s Project Management services with PMA for over three years. Erik earned a Bachelor of Architecture from Wentworth Institute of Technology and an MBA from Babson College and is a Registered Architect in Massachusetts. Erik is a member of the American Institute of Architects (AIA), the Construction Management Association of America (CMAA) and the Boston Society of Architects (BSA). He is a frequent presenter on BIM in the Boston area, and nationally, focusing on the Owner’s perspective of BIM 6D, BIM implementation and IPD “lite”.
Mark Dolny, AIA, LEED AP, Associate Principal, ARC/ Architectural Resources Cambridge With over fifteen years at ARC, Mark has an extensive amount of experience with educational clients having managed a large portion of the firm’s academic projects, including master planning and programming. Mark is currently overseeing the Albert Sherman Center (ASC) for the University of Massachusetts Medical School. In this role, he has managed all programming and design for the medical education facilities component of the ASC, specifically the development of the Center for Experiential Learning and Simulation (CELS) and the creation of new Student Learning Communities within the new facility.
Registration and Networking Reception: 5:30 pm to 6:15 pm Tour: 6:15 pm -6:45 pm Presentation: 6:45 pm to 9:00 pm
REGISTRATION FEES:
Before 01/11/2013: Members $50 Non Members $95* Student Members $5
After 01/11/2013: Members $60 Non Members $115* Student Members $10
*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 oroffice@ispeboston.orgfor more information.
PLEASE NOTE: Attendees may only attendoneprogram as a non-member.
ISPE Young Professionals Biotech Trivia Night Date: 23 January 2013
This event is sold out! Please contact the office to be put on a waitlist.
Come join the ISPE Boston Area Chapter Young Professionals for a night of trivia, appetizers, and socializing. Put your thinking caps on for a session of Geeks who Drink Trivia, and compete with your fellow pharmaceutical nerds for bragging rights, exciting prizes, and a raffle to benefit The Red Sox Foundation and Massachusetts General Hospital’s Home Base Program. Proceeds of the event and the 50/50 raffle will be donated to the charity.
This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields. It’s a great opportunity to meet other people from different areas of these stimulating and diverse industries and get involved with the International Society of Pharmaceutical Engineers, all with a little friendly competition and, of course, drink tickets.
Register early; there are a limited number of spots available. We’ll set up the teams, so all you need to do is be ready to show off your trivia skills.
ISPE FM Global SimZone Tour and Program: Identifying and Mitigating Common Hazards in Business Properties Date: 21 February 2013
Pre-registration is now closed. Walk-ins will be accepted on-site.
PROGRAM SUMMARY:
Every year businesses sustain billions of dollars of property damage. Some of these losses could have been prevented had hazards been identified and corrected prior to becoming catastrophic. FM Global, a multinational business property insurance company, has created an experiential learning facility called the SimZone to teach their engineers to identify and mitigate property-loss risks. The FM Global SimZone is a simulation-based classroom that brings to life real-world educational scenarios involving 90% of the common hazards found in typical business properties. These include fire protection, ignitable liquid storage and transfer, construction, equipment malfunction and electrical hazards. In the SimZone, thousands of possible property risk simulations can be created so that attendees may gain real-world experience in identifying and correcting possible hazards.
This program will give attendees a tour of the SimZone that will provide a rare opportunity to experience some of the training that FM Global provides its own engineers. This MEMBERS ONLY two-hour tour will provide attendees with a hands-on education of state-of-the-art loss-prevention strategies and equipment. The SimZone demonstrates a variety of wall and roof construction, industrial heating equipment, electrical equipment, ignitable liquid storage and use, and warehousing. The facility also includes a fire protection sprinkler system demonstration area complete with an electric and diesel pump, an array of risers, and a variety of sprinkler heads.
Following the tour and after the reception will be three presentations which are open to Members and Non-Members. The opening presentation will address two aspects of hazardous material storage in the typical process facility. First will be a review of some common steps required to identify hazards in typical process operations and options for reducing the presence or magnitude of these hazards. Following this discussion, our speakers will present code compliant design approaches for fire-protection and separation, based on the use and storage of flammable materials. The last presentation will be a showcase of the research and product testing capabilities at the FM Global Research Campus in West Glocester, R.I. The presentation will highlight the testing conducted at the Fire Technology Lab, Natural Hazards Lab, Electrical Hazards Lab and Hydraulics Lab.
SPEAKERS:
Dennis M. Anderson, P.E., Vice President, Engineering Application Manager, FM Global Dennis Anderson is vice president, engineering application manager, for FM Global. Based at FM Global’s Research Campus in West Glocester, R.I., USA,Anderson is responsible for addressing client, media, and business partner groups to illustrate the science and engineering capabilities. Appointed to his current position in 2003, Anderson previously served as vice president, chief engineer, and has been with FM Global for over 35 years. Anderson holds a master’s degree in business from Case Western Reserve University in Cleveland, Ohio, USA, and a bachelor’s degree in civil engineering from North Dakota State University, Fargo, N.D. He is a member of the National Fire Protection Association and the Society of Fire Protection Engineers, and is a registered professional engineer in Ohio and Wisconsin.
Eric Peterson, A.I.A., Senior Associate / Project Architect, Symmes Maini & McKee Associates Mr. Peterson is a Senior Associate and Project Architect at SMMA with over 25 years of experience. A central aspect of his work is the coordination of multiple disciplines in complex projects, and his experience in the technical and code aspects of architectural projects. His design experience includes projects for Shire Pharmaceuticals, Pfizer, Organogenesis, Draper Laboratories, MicroChem Corporation, Lyme Properties and Bose Corporation. Mr. Peterson holds a Bachelor of Science in Architecture and a Master of Architecture from the University of Michigan College of Architecture and Urban Planning.
Howard Sneider, Senior Process Engineer, Clark Richardson Biskup Mr. Sneider is a Senior Process Engineer at CRB. Previously, he was a Senior Process Engineer at Wyeth Biotech. He has over thirteen years of experience in all phases of process design, process modeling simulations, equipment design and selection, acceptance testing, start-up, commissioning, and validation. Mr. Sneider has participated in, and directed, the design of: biological, vaccine and API manufacturing processes, clean utilities, and facilities. His experience includes green-field and renovation projects at the lab, pilot, and commercial scale. He has worked closely with clients, vendors and construction managers to successfully execute and deliver design packages and construction support services. Mr. Sneider is a member of the ISPE Boston Chapter. He holds a BS degree in Chemical Engineering from Columbia University and a MS is Chemical Engineering from the University of Connecticut.
Registration for MEMBERS ONLY TOUR (Four Points Sheraton): 3:30 pm to 4:00 pm MEMBERS ONLY Tour (FM Global SimZone): 4:00 pm to 6:00 pm Seminar Registration (Four Points Sheraton): 5:30 pm to 6:00 pm Networking Reception (Four Points Sheraton): 6:00 pm to 6:45 pm Presentations and Q & A (Four Points Sheraton): 6:45 pm to 8:45 pm
REGISTRATION FEES:
Before 02/14/2013: Members $50 Non Members $95* Student Members $5
After 02/14/2013: Members $60 Non Members $115* Student Members $10
*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.
PLEASE NOTE: Attendees may only attend one program as a non-member.
ISPE CEO Free Throw Sponsor at Bio-Ball Date: 16 March 2013
Bio-Ball is a unique and exciting opportunity for biotechnology companies of Massachusetts to reap the rewards of volunteerism and invest in the community by sponsoring and staffing a special kind of March Madness. The marriage of the Massachusetts biotechnology industry and Special Olympics Massachusetts centers on a shared goal: the promise of a better tomorrow. While biotechnology companies strive to discover and create the innovations that will make for a healthier future, Special Olympics Massachusetts is dedicated to empowering individuals with intellectual disabilities and other closely related disabilities by giving them opportunities to develop physical fitness, demonstrate courage and participate in a brighter tomorrow. In addition to the synergies between the two organizations, volunteers at Bio-Ball have the unique opportunity to interact with the very beneficiaries of the event itself. The Massachusetts biotechnology industry is making the promise of a better tomorrow a reality by pursuing cures for many of the illnesses and disabilities that affect these athletes. In turn, the resilience of these athletes reminds us all in the biotechnology community why we strive so hard as an industry to persevere and fight to realize our goals of curing disease.
For more information on Special Olympics Massachusetts or to volunteer to help at Bio-Ball, visit their website here.
This program has been postponed until Tuesday, March 26th due to weather. If you have any questions, please contact the office at (781) 647-4773 or office@ISPEBoston.org.
PROGRAM: The Certified Pharmaceutical Industry Professional (CPIP) certification demonstrates competence in pharmaceutical industry practices. The study group will prepare industry professionals to qualify for CPIP certification.
Come to an informational meeting to learn more about the CPIP program and the spring study group. Each class will run from 5:30pm-9pm and the cost includes all 9 sessions. If after the informational session you choose not to continue the course, we will refund your registration fee.
REGISTRATION FEE: $150 This is a Members-Only Event. If you are not yet a member of ISPE, there's no better time to join! Visit www.ispe.org/join or call (813) 960-2105 today.
ISPE The Science and Risk Based Approach to C&Q: The Road to ASTM E2500 Date: 21 March 2013
Pre-Registration is Closed, but we will accept Onsite Registrations. If you have any questions, please contact the office at (781) 647-4773.
PROGRAM SUMMARY:
The introduction of ASTM E2500 and ICH Q9 (Quality Risk Management) have provided the Pharmaceutical Industry with a methodology to optimize commissioning and qualification activities resulting in improved compliance and a defined focus on product quality and patient safety. Efficient implementation of these practices provides the additional opportunity to reduce capital project timelines, and reduce life cycle costs.
Although the ASTM and ICH documents indicated the “What” in defining a science and risk based approach to system verification, the “How’s” of practical and efficient implementation of the supporting work processes had not been fully described and associated best practices had not been developed.
In order to help fill this need, the C&Q CoP sponsored the development of the ISPE Guide: Scienceand Risk Based-Approach for the Delivery Facilities, Systems, and Equipment that presents a structured life cycle approach to the delivery and verification of GxP regulated facilities, systems, and equipment. It supports the ASTM industry and ICH regulatory initiatives, including science based risk management approaches, a focus on product and process understanding, and the application of Quality by Design concept. In addition the C&Q COP formed a Task Team to develop a Good PracticeGuide- Applied Risk Management for C&Q that maps the transition and provides implementation strategies for moving from the traditional, or “Baseline Guide 5 approach” based on Impact Assessment to ICH Q9/ASTM quality risk management implementation.
This presentation will provide an overview these recent ISPE guidance documents and provide an overview of the implementation principles and elements contained therein.
SPEAKERS:
Dave Dolgin, Senior Quality Program Manager, Quality Systems Group, AbbVie Dave Dolgin is currently a Senior Quality Program Manager in the Quality Systems group of AbbVie (formerly Abbott). Dave has more than 35 years of Quality Assurance and Validation experience in the pharmaceutical industry and has been with Abbott/AbbVie since 1991. Dave led the C&Q task team in development of ISPE’s Good Practice Guide - Applied Risk Management for C&Q.
Steve Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc. Steven J. Wisniewski is Principal Compliance Consultant for Commissioning Agents, Inc. (CAI), provider of technical services for biotech and pharmaceutical manufacturers world-wide. Commissioning Agents focuses on the manufacturing process, with services including commissioning, validation, technology transfer, PAT, maintenance programs, SOPs, training and cGMP compliance.
Mr. Wisniewski offers more than 30 years experience in the pharmaceutical, biotech, and device industries. Prior to joining CAI he was Senior Associate and Director of Compliance for Drug and Device Associates. Mr. Wisniewski has served in senior management roles at Sterling Winthrop and Bausch & Lomb. He has completed a wide variety of pharmaceutical manufacturing, filling and critical support operations to major R&D laboratories, facilities and upgrades. He holds a BSME from Rensselaer Polytechnic Institute, is a Member of PDA, and an active Member of ISPE. He served on the ISPE Board of Directors beginning in 1982, and was Chairman of the Board in 1991. He served four terms as Chairman of the ISPE Community of Practice for Commissioning and Qualification, was a lead on the Task Team that drafted the recent ISPE Guide in support of Risk-based Qualification and served on the Task Team that completed the ISPE Good Practice Guide to address transitional Science and Risk-based (ICH Q9) approaches for C&Q. He was on the Team that developed the ASTM E2500 Standard and has also served as course leader and/or presenter at multiple ISPE C&Q conferences and co-authored several C&Q related articles.
Registration & Networking Reception: 5:30 pm to 6:30 pm Program: 6:30 pm to 8:30 pm
REGISTRATION FEES:
Before 03/14/2013: Members $50 Non Members $95* Student Members $5
After 03/14/2013: Members $60 Non Members $115* Student Members $10
*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.
PLEASE NOTE: Attendees may only attend one program as a non-member.
ISPE Medieval Manor: Young Professionals Social Date: 28 March 2013
Come join the ISPE Boston Area Chapter Young Professionals at the Medieval Manor for a bawdy but lighthearted interactive romp through the dark ages! Enjoy one-of-a kind entertainment as you feast on six courses without a fork, knife, or spoon (vegetarian meals are available). Beer and Red/White wine will also be provided with the dinner. If you need a vegetarian meal, please contact the office at 781-647-4773 or office@ispeboston.org.
Get there early as there will be a “meet and greet” social at 6:30!
Space is limited, so get your tickets now before it’s too late!
If you are graduating this year or a few years from now, you will benefit from a workshop designed to help you to hone your skills and improve your chances of getting that internship or permanent position in the Life Sciences Industry.
ISPE Boston has assembled a group of industry experts to help you:
* Get the Interview * Get the Job * Build Your Network * Build Your Career Path * Learn From Industry Pros
ATTENTION STUDENTS! Register to compete in the Annual Student Poster Contest. Two winning students, one each from the graduate and undergraduate categories receive a FREE TRIP to compete at the International Student Poster Competition at ISPE’s Annual Meeting in Washington, D.C. on November 3-6, 2013. Winners of the International competition receive cash awards and have the opportunity to publish their materials in ISPE's Pharmaceutical Engineering magazine, as well as other Chapter/Affiliate publications.
ISPE Facility Tour & Dual-track Seminar Date: 18 April 2013
Pre-registration is closed. Walk-ins will be accepted on-site.
Facility Tour – The New WPI Bioengineering Center Track 1: Process Validation – Practical Aspects of the New Guidance Track 2: Biotech 101 – Empowering You with the Basics of Biopharmaceuticals
TRACK 1: Process Validation – Practical Aspects of the New Guidance
In January 2011 the FDA issued new Guidance for Industry on Process Validation, which replaced guidance issued over 20 years ago. The FDA Guidance is intended to align Process Validation practices with a “lifecycle” concept as well as with the principles outlined in ICH Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality Systems). This session will review the FDA Guidance just issued, and will summarize the efforts of ISPE’s Process Validation Implementation Team, including some practical considerations for implementing the new approach. In addition, observations from establishing a Stage 3 “Continued Process Verification” program for legacy products will be shared, including challenges and lessons learned.
SPEAKER:
Rusty Morrison, Commissioning Agents, Inc Rusty (Russell) Morrison is the Director of Process and Technical Services for Commissioning Agents, Inc., where he is responsible for the sales, marketing, and execution of process validation and technology transfer projects. He has directed multiple process validation efforts, including the complete process validation for the startup of a large cell culture monoclonal antibody manufacturing facility, and remedial process validation for a manufacturer of numerous small volume sterile parenteral products, including designing a continued process verification program.
Mr. Morrison is a member of PDA and ISPE, and is currently serving as a member of ISPE’s Process Validation Implementation Team. In addition, he is a past president and current board member of the PDA New England Chapter. Prior to Commissioning Agents, Mr. Morrison held management / engineering positions with Protein Sciences Corporation, INNCOM International, and Sonalysts, Inc., and served as a submarine officer in the United States Navy. He has a BS in chemical engineering with honors from the University of Minnesota and an MBA in Information Systems from Rensselaer Polytechnic Institute.
TRACK 2: Biotech 101 – Empowering You with the Basics of Biopharmaceuticals
What goes on inside a biotech manufacturing facility? How are these lifesaving drugs actually made? What is upstream? What is Downstream? ISPE’s Boston Area Chapter is bringing you the answers to these questions and much more in their Biotech 101 session at WPI. In this session, we will show you the process of how biotech based drugs are made, the typical systems required to maintain a robust facility, and the critical quality attributes and process parameters associated with manufacturing. No matter what your experience level, this behind the scenes look into drug manufacturing will enhance your understanding of how a single cell is turned into a lifesaving therapy.
SPEAKER:
Alex Cardoso, Biogen Idec Alex Cardoso is a Process Engineer at Biogen Idec, where he is responsible for the process support, equipment design and technology transfer projects. He has been a technical lead on all scales of production, taking processes from the initial small scale into large commercial scale, including process validation. His experience includes both mammalian and microbial production as well as both upstream and downstream activities.
Prior to joining Biogen Idec, Mr. Cardoso held positions in manufacturing/engineering with Lonza, CRC Consulting, and Amgen. He has a BS in Chemical Engineering from the University of Massachusetts Amherst and is a member of ISPE.
Registration: 5:30 pm to 6:00 pm Networking Reception and Facility Tour: 5:30 pm to 6:30 pm Program: 6:30 pm to 8:30 pm
REGISTRATION FEES: PLEASE NOTE NEW LOWER RATES FOR THIS DUAL-TRACK PROGRAM
Before 04/11/2013: Members $30 Non Members $55* Student Members $5
After 04/11/2013: Members $40 Non Members $75* Student Members $10
*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.
PLEASE NOTE: Attendees may only attend one program as a non-member.
ISPE Student AbbVie Plant Tour and Educational Program Date: 22 April 2013
Pre-Registration has closed, but we are still accepting Walk-in Registrations.
PROGRAM SUMMARY:
AbbVie, a worldwide leader in the biopharmaceutical industry, opens the doors of its Worcester facility for a one of a kind tour and educational program geared specifically to students. A combination of posters, equipment exhibitions, presentations, and employee led tours will give attendees first-hand knowledge of how manufacturing and research are done at AbbVie and will provide valuable insights to students interested in careers in the biopharmaceutical industry. Gain real world knowledge through this in-depth learning opportunity while building your understanding of some of the career paths available to you.
EDUCATIONAL PROGRAM:
Introduction to Biologics Development & Manufacturing by Gary Welch, Plant Manager, AbbVie
This informative presentation provides background on the manufacturing capabilities at AbbVie’s multi-product biologics manufacturing facility and describes the practical aspects of how cross-functional teams of scientists and engineers are integrated into the process. The presentation is geared towards students and emerging professionals and provides an introduction to biologics development & manufacturing. An overview of common biotech unit operations found in industry will also be presented. The discussion for each unit operation reviews basic theory, principles, and the use of these techniques for antibody production.
Introduction to Engineering at AbbVie by Steve Granger, Technical Support Manager, AbbVie
This presentation will provide a brief overview of the typical responsibilities of chemical engineers at a biologics manufacturing and launch facility. Typical engineering tasks and decisions will be discussed in the context of the overall asset life cycle for bioprocessing equipment. Designed specifically for new or soon-to-be engineering graduates, the presentation will provide some insight into the day-to-day expectations and responsibilities for practicing chemical engineers in a biopharmaceutical manufacturing environment.
PLANT TOUR:
Employee led tours will bring attendees through AbbVie’s laboratories, scale up area, and production facility providing insights on how the plant operates to develop and produce antibodies.
ISPE INTERPHEX Bus Date: 23 April 2013 - 24 April 2013
Pre-registration is closed. Walk-ins will be accepted on-site.
Traveling to INTERPHEX from the Boston area? Sign up for a Complimentary Roundtrip Shuttle Bus.
Buses will depart Boston on April 23 and 24 at 7am. Return trip departs from the Jacob K. Javits Center in NYC at 6pm on April 23 and 4:30pm on April 24. Take a one-day bus or stay over night.
Pick-up Location: The Rt 128 Parking Lot at Blue Hill Dr & University Avenue Westwood, MA.
NOTE: please disregard any reference to "seminars" or "seminar selection." We had to modify our seminar registration to accept bus reservations. You must select a bus trip below. Thank you.
ISPE AUTOMATION: At the Crossroads with IT Interfaces Date: 16 May 2013
Pre-registration is closed for this program. We will be accepting onsite registrations. If you have any questions, please call the office at 781-647-4773.
PROGRAM SUMMARY:
In January 2011 the FDA issued new Guidance for Industry on Process Validation, which replaced guidance issued over 20 years ago. The FDA Guidance is intended to align Process Validation practices with a “lifecycle” concept as well as with the principles outlined in ICH Guidelines Q8 (Pharmaceutical Development), Q9 (Quality Risk Management), and Q10 (Pharmaceutical Quality Systems). This session will review the FDA Guidance just issued, and will summarize the efforts of ISPE’s Process Validation Implementation Team, including some practical considerations for implementing the new approach. In addition, observations from establishing a Stage 3 “Continued Process Verification” program for legacy products will be shared, including challenges and lessons learned.
PRESENTATION ONE: Process Data Management and the Changing Role of the Automation Engineer As the need for business and process data grows, companies are commissioning more specialized computerized systems, sometimes with a great deal of overlap leading to redundant data being stored in multiple systems. ANSI/ISA95 (Enterprise-Control System Integration) addresses this problem by setting standards for communications within the enterprise layers of manufacturing and operations. The role of the automation engineer is being transformed into that of a business analyst in order to streamline processes such as materials management, computerized maintenance, and procurement. Service Oriented Architecture, Web Services, and OPC communications will be discussed. Systems to be explored include DCS, MES, EDMS, EQMS, CMMS, and Plant Historians.
SPEAKER ONE: Jordan Croteau is an Automation Engineer in Biogen Idec Cambridge Manufacturing Engineering. Jordan has served as technical lead for numerous projects on process automation and control and IT systems, with a process data management focus. Before Biogen Idec, Jordan spent three years working for automation integrators and process skid manufacturers. Jordan earned a Bachelor of Science in Chemical Engineering from Worcester Polytechnic Institute, and is a member of the International Society of Automation (ISA) and an Information member of the ISA95, ISA18, and ISA100 committees.
PRESENTATION TWO: Implementing an Equipment Monitoring System with an Operations Information Infrastructure This presentation describes the installation of an automated Equipment Monitoring System providing “review by exception” electronic reports with automated routing and e-signature approvals to replace an existing manual paper-based GMP record for logging equipment temperature readings, and related process data and information. The execution of this project required the implementation of a site-wide Operations Information Infrastructure which will also be discussed as the basis on which future “electronic initiative” application projects will be integrated.
SPEAKER TWO: Kenneth S. Kovacs is the QA Business Systems Manager at Fujirebio Diagnostics, Inc. in Malvern, PA and a Certified Management Consultant (CMC). He has in-depth knowledge in Life Sciences Industry operations, manufacturing, and technology transfer through 35 years of experience working with companies including Johnson & Johnson, TAVA Technologies, and Rockwell Automation. Ken is an active member of ISPE and GAMP America’s MES SIG. He is an original member of the ISA-95 committee that developed the “Enterprise-Control System Integration” international standard, a past Director of ISA’s Food and Pharmaceutical Industries Division, and a co-author of both the textbook “Automation and Validation of Information in Pharmaceutical Processing” and the GAMP® Good Practice Guide: Manufacturing Execution Systems Control and Compliance”. Ken has a Bachelor of Engineering degree from Villanova University and an MBA from Xavier University.
SPEAKER THREE: Glenn Restivo is the Director of Business Development Life Sciences, Chemicals, Food and Nutrition for M+W Automation. His role is to develop and promote automation and manufacturing IT solutions for pilot and commercial manufacturing addressing industry, business and regulatory challenges. He focuses his efforts on meeting the customer’s time to market, minimizing project risk, optimizing solutions and using state of the art technology that supports project lifecycle and asset management. He received a bachelor’s degree in chemical engineering from Stevens Institute of Technology in Hoboken, New Jersey. In addition, he actively participates with the International Society for Pharmaceutical Engineers (ISPE), MIT’s Center for Biomedical Innovation (CBI), Rutgers Engineering Research Center (ERC), Next Generation Pharma Workshops and has articles on PAT/QbD and RFID published in key industry trade magazines.
Registration & Networking Reception: 5:30 pm to 6:30 pm Program: 6:30 pm to 8:30 pm
REGISTRATION FEES:
Before 05/09/2013: Members $50 Non Members $95* Student Members FREE
After 05/09/2013: Members $60 Non Members $115* Student Members FREE
*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 oroffice@ispeboston.orgfor more information.
PLEASE NOTE: Attendees may only attend one program as a non-member.
ISPE Young Professionals Bowling Social Date: 29 May 2013
This event is sold out! Please contact the office to be placed on a waitlist.
Come join the ISPE Boston Area Chapter Young Professionals at The Flatbread Company in Davis Square for an evening of pizza, socializing, and candlepin bowling at the famous Sacco’s Bowl Haven! Enjoy a variety of wood-fired, clay oven flatbread pizzas (vegetarian options will be offered). Bowling shoes will be provided and a cash bar will be available.
Space is limited, so get your tickets now before it’s too late!
ISPE Young Professionals Red Sox Social Date: 6 June 2013
This event is sold out! Please contact the office at office@ISPEBoston.org to be placed on a waitlist.
Come join the ISPE Boston Area Chapter Young Professionals for a fun-filled Red Sox game against the Texas Rangers on Thursday, June 6th. We’ll meet to pick up tickets and enjoy some social pre-game beverages at Remy’s Bar. Availability is limited, so register today!
6:00 pm – Pre-Game Social
Jerry Remy’s Bar 1265 Boylston St Boston, MA 02215
7:10 pm – Red Sox Game vs. Texas Rangers
Fenway Park
$10 for Members and $20 for Non Members Limit One Ticket per Person Pre-Registration is Required
ISPE Our Process Is Working, Right?: How do you really know? And can you know in the moment? Date: 20 June 2013
PROGRAM SUMMARY:
Come join the Boston Area Chapter for a dual track educational program focused specifically on Validation, defined as “the process of using objective evidence to establish that a process consistently produces a product or result meeting a predetermined specification.” Validation is such a broad topic that we can’t possibly cover everything with one program – so we’ve split the program into two concurrent tracks, one introductory and one advanced to best meet the varied needs of our membership. The introductory track consists of two presentations focused on providing attendees with the basics of validation along with why validation is required from an agency, process, and product lifecycle perspective. The advanced track takes a detailed look at validation beginning with a summary of industry and FDA contributions to the FDA Process Validation Guide. Two presentations will then focus on the emerging field of Continuous Process Verification (CPV) describing both a theoretical and actual case study detailing how CPV was implemented by a local life sciences company. The Tufts Gordon Institute in Medford has generously offered their facilities to host this program.
INTRODUCTORY TRACK:
This program begins with an introduction to the key regulatory agencies and their expectations with a practical discussion of product lifecycle implications. Next, the program shifts focus to provide attendees with an overview of validation basics and the key tenets behind validated processes and products. Attendees will come away with an understanding of the mindset behind and importance of integrating the process behind the product.
SPEAKERS:
Rich Yeaton is President of East Coast Validation Services, LLC in Derry, NH, and has over twenty years experience working in FDA regulated industries. He was initially introduced to GMP operations on the Devices side as a Development Engineer in DuPont’s Medical Products division, where he developed and improved new process equipment, and then was told to validate what he had designed.
He moved on to help start Phoenix Imperative, an Engineering and Validation consulting company serving the BioPharm industry. A key achievement with Phoenix was leading validation teams to assist MedImmune to obtain its first two commercial licenses. He has since worked with small startup companies and larger operating companies such as Shire, Merck, Genzyme, Wyeth and Lonza. He has in-depth experience with facility shutdowns and startups. He recently assisted Avecia Biologics, a microbial fermentation Contract Manufacturer, to successfully prepare for their first Pre Approval Inspection. He is currently working with a GMP Operating company to manage Process, Cleaning and Equipment validation efforts for a new combination product under development. He is a member of ISPE, PDA and AAMI and has degrees in Electrical Engineering and Mechanical Engineering from Lehigh University.
Jack Campion, PE, has held positions in process design, design-build project management, validation, and validation management for twenty-four years.
He led the commissioning, qualification and process validation program for MassBiologics' 100,000 square foot cell culture and aseptic fill-finish facility in Mattapan. In this role, Jack applied the ISPE Baseline® Guide Volume 5: Commissioning and Qualification, saving countless labor hours and weeks of schedule through careful system definition and elimination of redundant testing. Jack was also a member of the design team and was responsible for system turnover and acceptance from the construction manager.
Jack holds a BA in chemistry from the College of the Holy Cross and an MS in Chemical Engineering from Tufts University. He is a registered Professional Engineer in Massachusetts. Jack is currently Manager of Project Controls for capital projects at Genzyme's Allston Landing Facility. He is a former Treasurer and current Member of the Board of Directors of the ISPE Boston Area Chapter.
ADVANCED TRACK:
This program takes a deep dive into the practical aspects of Process Validation. ISPE has solicited input from the industry as well as the FDA, and has developed an impressive stable of best practices in Process Validation. Our first presentation reviews the content of these reference materials. The second presentation focuses on the emerging field of Continuous Process Verification (CPV), which is considered the Holy Grail by both the FDA and the industry. Selection of critical process parameters to monitor, analyze data, and respond to process variability will be discussed first as part of a theoretical case study and then as applied in a real world example currently in use. Biogen Idec has developed a quantitative method for chromatogram review/evaluation. Multivariate analyses of the discrete parameters have been applied for evaluation and scale-down model verification. The author shares the journey of electronic chromatogram evaluation including the use of such methodology to identify the root cause for a product quality shift.
SPEAKERS:
Peter Levy has been involved in process development for the BioPharmaceutical and related industries for over 30 years. He began providing consulting services to the Pharmaceutical Industry in the areas of Process Development, Manufacturing, Technical Transfer, and Process Validation in 2007. He received his B.S. degree in Chemistry from Tufts University and M.S. degree in Chemical Engineering from Massachusetts Institute of Technology.
Past employers include Biogen, Inc (Director Development Engineering & Validation), Millennium Pharmaceuticals (Director Biologics Process Development), Altus Pharmaceuticals (Director Process Development & Engineering), and Amicon Division of WR Grace & Company (Manager, Process Filtration Applications). His focus has been on downstream processing of recombinant proteins with an emphasis on liquid-solid separations. His experience includes the development of processes and process equipment as well as technical transfer, start-up, and validation of clinical and commercial protein processes.
Mr. Levy is an active member of ISPE and participated in the ISPE PQLI PV Implementation Team that produced two discussion papers in 2012 and is presently working on 4 more discussion papers related to Process Validation.
Dr. Lilong Huang joined Biogen Idec in 2012 and is currently leading the global advanced process control (APC) initiative within the company. The mission of Biogen Idec’s APC initiative is to transform research, development, and manufacturing data into better process understanding and eventually into actions to achieve improved product quality. Dr. Huang has worked in Chemical, Vaccine, and Biological industries for the past 9 years. Prior to joining Biogen Idec, he worked at Bayer, Merck, and Genzyme. His expertise includes manufacturing support, new facility startup, facility utilization optimization, data analytics and process monitoring/control.
Dr. Huang graduate from Beijing University of Chemical Technology in 1996 with a Bachelor of Science degree and from Tsinghua University in 1999 with a Master of Science degree both in Chemical Engineering. He received a Ph.D. in Chemical Engineering from Lehigh University in Bethlehem, PA in 2004.
MEETING MANAGERS:
Brian Hagopian, CPIP, Clear Water Consulting
Armen Nahabedian, Pfizer
Chiderah Okoye, Venly, Inc.
SCHEDULE: Registration & Networking Reception: 5:30 pm to 6:30 pmProgram: 6:30 pm to 8:30 pm Introductory and Advanced Tracks Run CONCURRENTLY. You Must Choose One to Attend.
REGISTRATION FEES: Before 06/13/2013: Members $50Non Members $95*Student Members FREE
After 06/13/2013:Members $60Non Members $115*Student Members FREE
*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 oroffice@ispeboston.orgfor more information.
PLEASE NOTE: Attendees may only attend one program as a non-member.
ISPE Bluegrass and BBQ Summer Social Date: 26 June 2013
Enjoy great bluegrass music and BBQ food (veggie options available) with your friends and colleagues! Network with ISPE members you know and meet new members and guests. Entertainment provided by The Four Legged Faithful band.
Registration Fees:
$10 for ISPE Members $20 for non-members
Location:
Tommy Doyle’s Pub, 1 Kendall Sq #100, Cambridge, MA
ISPE Young Professionals Volleyball Social Date: 16 July 2013
Come join the ISPE Boston Area Chapter Young Professionals for a fun-natured, yet competitive evening of outdoor volleyball on Tuesday, July 16th. We'll have two nets set up for tournament-style play and then head over to the Warren Tavern for post-game nourishment and networking.
Both skilled players and recreational players should feel free to play! If volleyball isn't your thing, come down and cheer on your co-workers and industry peers and join us at the Warren Tavern later that night!
Availability is limited to the first 36 participants who sign up, so REGISTER TODAY!
LOCATION:
Outdoor Volleyball Tournament Bunker Hill Community College 250 Rutherford Ave Charlestown, MA 02129
Post-Tournament Social The Warren Tavern 2 Pleasant Street Charlestown, MA 02129
SCHEDULE:
6:00 pm – 8:00 pm Volleyball Tournament
8:00 pm - 10:00 pm Networking Social
FEES:
Members $10 Non Members $20
Price includes post-tournament appetizers and cash bar
ISPE Educational Programs 2014 Season Planning Meeting Date: 18 July 2013
ISPE Educational Programs 2014 Season Planning Meeting
This summer, the Boston Area Chapter received valuable input on educational programs of interest to our Members. The Educational Program Committee has reviewed this information and we would like YOUR help to finalize the educational program content for the upcoming Chapter year. Please join us on Thursday, July 18, 2013.
Schedule 5:30 PM - 8:30 PM Dinner, planning the 2014 programming year, and brief committee meeting
Attendance and parking are free (we want your assistance) and food will be provided!
ISPE Membership is required in order to participate in any Chapter Committee. To become a member, click here and select the Boston Area Chapter.
ISPE 11th Annual Golf Tournament Date: 29 July 2013
SCHEDULE: 7:30 - 8:30 AM - Registration and Continental Breakfast 8:30 AM - Shotgun Start - Scramble Format 1:30 - 3:30 AM - Reception/Cocktails/Buffet Lunch
REGISTRATION FEES: $1,000/Foursome (Includes Continental Breakfast, Lunch, and Golf for each player)
There is still one contest hole available for this year's tournament!
Product Show Training Camp: How to Make October 2nd Easy, Fun and Profitable! Date: 14 August 2013
PROGRAM: Want to get the most out of your Product Show experience? Do you see other companies breezing in and out of Gillette and wonder how they do it? This informative session will take you from pre-Show marketing, to display best practices, materials load-in, trade show etiquette and a tour of Gillette Stadium that will Show you the quickest way to get around. Hear from Product Show veterans, Gillette Stadium representatives and Capital Convention personnel.
Who Should Attend: *Any Pre-Registered Exhibitors * First Time Exhibitors * Anyone that wants to get the most out of their Product Show experience!