Boston Area Chapter Past Events Calendar

Pre-Registration is Closed.  Walk-In Registrations will be accepted on-site.

PROGRAM:  Use of Integrated Commissioning and Qualification models based on ASTM E2500 offers a rare opportunity – a chance to deliver projects that meet user and product needs, with the full documentation package required by regulatory authorities, and do it on time and within budget. However, having your cake and eating it too requires a departure from the traditional approach. This evening’s program will lay out a series of C&Q models, explain how they work (or do not work) and use first hand case studies to highlight the benefits and risks of each. This workshop will be presented in two parts, the first will be a presentation of various models and chronicle their history and the second will address how to set up integrated C&Q programs. Bring your questions and do not hesitate to interrupt in this interactive workshop!

 Click here for the 12/15/2011 Handouts

SPEAKER: Jack E. Greene

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:

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.

THANK YOU TO OUR PROGRAM SPONSOR:
Masy Systems, Inc.

Pre-Registration is now closed. Walk-ins will be accepted on site.

Pharmacogenomics: The future of clinical trials, new product development and the practice of medicine

WHO SHOULD ATTEND: Pharmaceutical Company to Doctor to Patient or anyone in between. Pharmacogenomics is the study of how an individual's genetic inheritance affects the body's response to drugs. Hear how the future may hold the promise that drugs might one day be tailor-made for individuals and adapted to each person's own genetic makeup. In this interactive workshop, Michael Drues will present where we are today and what people are already thinking about.

PRESENTATION: Pharmacogenomics, also known as personalized medicine, has received increased attention in recent years.  But what is pharmacogenomics and it really a new idea?  This presentation will focus on:

*  What is pharmacogenomics?  Is it really a new idea?
*  How will pharmacogenomics impact the way we do clinical trials?
*  How will pharmacogenomics affect new product development?
*  How will pharmacogenomics change the way we practice medicine?
*  Other interesting issues to ponder (time permitting)

During this interactive workshop, participants will be exposed to multiple examples of pharmacogenomics applications currently on the market, under development and on the drawing board.

SPEAKER: Michael Drues, Ph.D. Vascular Sciences

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:

Members $60
Non Members $115*
Student Members $10

*Join ISPE within one week of this meeting, and we’ll refund you the difference between the Member and Non-Member rate!

THANK YOU TO OUR PROGRAM SPONSOR:
Masy Systems, Inc.

Young Professionals vs. Seasoned Veterans

Wednesday, November 2, 2011
6:45 pm until 9:00 pm
Teddy Ebersol’s Red Sox Field, Embankment Rd, Boston, MA

The Challenge: On Wednesday, November, 2, the ‘Young Professionals’ challenge the ‘Seasoned Veterans’ to a game of Softball.

The Stakes: The unfortunate team that does NOT prevail will purchase the first round at Beacon Hill Pub, 149 Charles St, Boston MA 02114 immediately following the game.

It's time to once again ransack that old cabinet, grab your glove and bring your guts to join your comrades in an epic battle for glory!

Be there to support your squad as the battle rages pitting old guard vs. newbie, done-that vs. rookie, young-at-work vs. young-at-heart and finally… good vs. evil (well maybe not that one). Also don’t worry, both skilled and unskilled players should feel free to play.

Note: Parking is extremely limited. Public transportation is the best way to reach the field, either by Charles/MGH stop on the Red line or Science Park stop on the Green line. There is also paid parking at the Mass Eye & Ear Infirmary Parking lot and metered parking along Charles St.

DON’T FORGET TO REGISTER BEFORE THE LINE-UP IS DECIDED!

Price:  $15 for Members  $20 for Non-Members

Please note: This is the new date for the Golf Tournament due to the weather on 8/15/2011. The tournament is still currently sold out.

This year, the Chapter will hold its Annual Golf Tournament at a new location!
Click here to view the Indian Pond Country Club

Schedule:
7:30-8:30 AM - Registration and Continental Breakfast
8:30 AM - Shotgun Start - Scramble Format
1:30-3:30 PM - Reception/Cocktails/Buffet Lunch

Pre-Registration has CLOSED. Walk-Ins will be accepted on-site!If you have any questions call the ISPE Office at 781-647-4773.

ISPE Product Show - Morning Educational Sessions, hear the Keynote Address and visit over 300 exhibitors in the afternoon Show Floor from noon to 7:30 pm. Jonathan Kraft, President, The Kraft Group, to deliver this year's Keynote Address. Plan your day using the schedule below. 

Click here for full educational program descriptions.

Also new this year, attend the Product Show and pick-up a free wristband from an exhibitor to attend the After-Party Networking Reception at CBS Scene. Scheduled to appear is Jerod Mayo, New England Patriot Linebacker. Don't miss this opportunity to meet Mayo and get an autograph signed!

SCHEDULE:
Educational Seminars: 9:00 am to 12:00 pm
Attendee Lunch SOLD OUT
Exhibitor Show Floor: 12:00 pm to 7:30 pm
Keynote Address: 3:30 pm to 4:45 pm
After Show Networking Reception: 7:30 pm to 9:30 pm

* The 20th Annual Product Show and Educational Sessions are FREE to attend. The Lunch and Patriot Hall Tour are Sold out. 

Come join the ISPE Boston Area Chapter, Young Professionals for our kick-off event of the season! New and returning Members are welcome to enjoy in a night of appetizers, socializing, and networking as we tour the Boston waters.

This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields. Hosted by the Boston Belle Charter Company- this is a great opportunity to meet other people from different areas of these exciting and diverse industries and get involved with the ISPE.

Registration Fees:
Before 9/22
Members: $20 and Non-Members $25

After 9/22
Members: $30 and Non-Members $35

Risk Management is more than performing a one-time risk assessment; it is about imbedding it within the product and process lifecycle. This evening’s program spotlights its use at two different points along the life cycle, in equipment design, and in manufacturing. Please join your fellow colleagues in learning how to better use risk management in the exciting field of Human Factors and the important Root Cause Analysis process.

PRESENTATION ONE:
Investigating the Problem: Use of Risk Management in CAPA Root Cause Analysis
Susan Reilly 

PRESENTATION TWO:
Mitigating Pharma Equipment Risk Through Human Factors 
Christina Mendat, PhD

Click here for the 9/14/2011 Handouts

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:
Members $60

Non Members $115
Student Members $10

THANK YOU TO OUR PROGRAM SPONSOR:
Masy Systems, Inc.

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 representative and SER Expo personnel.

Who Should Attend:
* Any Pre-Registered Exhibitors
* First Time Exhibitors
* Anyone that wants to get the most out of their Product Show experience!

PROGRAM SCHEDULE:
1:30 – 2:30 PM           Registration and Networking Reception
2:30 – 4:00 PM           Program, Q&A
4:00 – 5:00 PM           Tour of Loading Docks and Show Floor, Wrap-up and Final Q&A 

REGISTRATION FEES:       
1^st Company Attendee           $25
2^nd Company Attendee          FREE

Pre-Registration is closed, but walk-ins will be accepted at the door. 
If you have any questions, call the office at 781-647-4773.

The International Society for Parrothead Engineering - Boston Area Chapter Social Committee invites you to their Summer Social, “It’s Five O’Clock Somewhere”, on June 30^th, featuring the Cocabanana Band.  With songs from Jimmy Buffett and Latin rhythms, a small bit of the Caribbean will be created on the roof top of the Baseball Tavern in Boston overlooking the great Fenway Park, No game this night so parking is available and cheap, plus it’s walking distance to the T.

There will be prizes for the best Parrothead costume, a Limbo competition, and a toy drive to benefit the Children’s Hospital Boston.

And of course, sandals and sunglasses are highly recommended! For the Summer Social flyer and donation information, click here.

Do you find yourself being asked to provide leachables and extractables data, and wondering where to begin? Learn how to share data and knowledge with other industry professionals to save valuable time and resources, and allow yourself to focus on your process.

The Extractables and Leachables Safety Information Exchange (ELSIE) is a consortium of pharmaceutical, biotech, and medical device companies that is developing a database that will hold (i) safety information on extractables and leachables from a variety of materials; and (ii) controlled extraction study information from materials used in container closure systems, devices, and bioprocessing. The ELSIE database offers a number of valuable potential benefits including reducing duplicative safety studies, streamlining the search for safety information for extractables and leachables. It also provides E & L information that companies can use early in their development, to reduce the risk of resource-draining leachables issues arising at the end of development. Ultimately this will help companies deliver high quality drug products to patients in a timely manner. During the ISPE seminar, ELSIE representatives will provide background on leachables and extractables, review the consortium's key priorities and recent progress, and demonstrate the Safety Information Database.

MEMBERS ONLY TOUR (45-minutes): The 460,000 square foot main building at Abbott Bioresearch Center houses biopharmaceutical research and production. See key areas related to the multi-product production facility; including, the first floor utility area to view pure water systems, chillers, boilers and water treatment, and a neutral corridor (minimal gowning) view into clean room production areas (cell culture, purification and glass wash).

SPEAKERS:
William P. Beierschmitt, PhD, DABT
Dr. Arthur Shaw

Click here for the 6/16/2011 Handouts

SCHEDULE:
Registration and Networking Reception: 4:45 pm to 6:30 pm
Members Only Tour of Abbott Bioresearch Center
Program: 6:30 pm to 8:30 pm

REGISTRATION FEES:
Members $60
Non Members $115
Student Members $10 

THANK YOU TO OUR PROGRAM SPONSORS:
GxP Automation
SciTech Builders
Waters Corporation
Worcester Polytechnic Institute

Come join the ISPE Boston Chapter’s Young Professionals for a night of craft beer tasting, appetizers, socializing, and networking. We will have our own private function room with fifteen craft beers open for tasting and three of Gordon’s beer experts to discuss the beers.

This event is geared towards facilitating social and professional networking between people in the pharmaceutical, biotech, and life sciences fields. This is a great opportunity to meet other people from different areas of these exciting and diverse industries and get involved with the International Society of Pharmaceutical Engineers, all while enjoying delicious craft beers from around the world.

Registration Fees:

Members: $20
Non-Members: $25

PROGRAM:
We are delighted to present two lectures focusing on the challenges and successes of process scale-up and technology transfer of biopharmaceutical manufacturing processes that use emerging, novel production host organisms.  Our speakers have participated in the development of cutting edge production technologies that provide new, robust alternatives to the biotechnology industry.  They will provide an overview of the benefits of the following novel technologies followed by case studies:

     * Pseudomonas fluorescens developed by Pfenex, and
     * PER.C6® human cell lines developed by Percivia.

SPEAKERS:
Lawrence Chew, Ph.D., Director of Fermentation Development, Pfenex
Rachel Hoff, Associate Scientist, Upstream Process Development Group, Percivia
Anna Tchoudakova, Ph.D., Scientist, Cell Line Developement Group. Percivia

Click here for the 5/19/2011 Handouts

MODERATOR:
Susan Dana Jones, Ph.D., VP and Senior Consultant, BioProcess Technology Consultants

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:
Before May 12th
Members $50
Non Members $95
Student Members $5

After May 12th
Members $60
Non Members $115
Student Members $10 

THANK YOU TO OUR PROGRAM SPONSORS:
GxP Automation
SciTech Builders
Waters Corporation
Worcester Polytechnic Institute

It's a black box, right? OK, it's a stainless steel, skid mounted process system. It is shiny, has lots of pipes, instruments and equipment, cost a lot of money, but it may not work exactly the way you want it to work. Come to this highly interactive session to share and learn about how these skid based process systems go from the drawing board to the production environment.

The Boston Area Chapter of ISPE has assembled subject matter experts who have lived through all steps of the process from conceptualization to operation and will share their experiences through our interactive "talking shop" series. Bring your questions, comments, and experiences to share with the group and be ready to participate.

The program has been broken into three segments, with each having a short presentation followed by a peer to peer open discussion.

Part 1: Design considerations, engineering, determining user requirements, and producing a functional requirement specification.
Part 2: Buy out of the equipment, terms and conditions, fabrication, factory visits and factory acceptance testing.
Part 3: Installation, startup, and commissioning of the system.

SPEAKERS:
Experts Rich MacLean from Biogen Idec, Ron Berk from Hyde Engineering and Ray Foley from Parsons will cover all the bases and will be ready to answer any questions you have. The session will be moderated by Niall Johnson, past president of the Boston Area Chapter. 

Click here for the 4/21/2011 Handouts

SCHEDULE:
Registration and Networking Reception: 5:30 pm to 6:20 pm
Presentation: 6:20 pm to 8:30 pm

REGISTRATION FEES:
Before April 14th
Members $50
Non Members $95
Student Members $5

After April 14th
Members $60
Non Members $115
Student Members $10 

THANK YOU TO OUR PROGRAM SPONSORS:
GxP Automation
SciTech Builders
Worcester Polytechnic Institute

The ISPE Boston Young Professionals are hosting this educational and social event for students, young professionals and anyone else interested in learning about Clean-In-Place (CIP) systems. The ISPE Young Professionals group was formed to foster the ideas and professional needs of individuals who are establishing their careers in the biotechnology and pharmaceutical industry. The primary focus of this group is education, career/professional development, and networking.

Pre-Registration is now closed. We will accept walk-ins. If you have any questions, please call the office at 781-647-4773.

PRESENTATION:
This seminar will give all participants a general overview of the requirements for developing a successful CIP system and cycle. The first portion of the presentation will focus on CIP basics, including designing and building a CIP system and the critical process parameters and quality attributes associated with CIP systems. During the second portion of the seminar the audience will walk through the development of a CIP cycle.

SPEAKER:
Lou Traglia is a senior project manager for Commissioning Agents Inc. (CAI). 

SCHEDULE:
Registration and Networking Reception: 6:00 pm to 6:30 pm
Presentation: 6:30 pm to 8:30 pm

REGISTRATION FEES:
Before March 30th
Members $20
Non Members $30
Student Members $5

After March 30th
Members $25
Non Members $35
Student Members $10

Pre-Registration for this event is Closed. We will be accepting walk-in registrations onsite. If you have any questions please call the office at 781-647-4773.

Discover the latest information on hiring trends, skills required and other tips to help you obtain a career in the pharmaceutical, biotech and medical device industry.

A full day workshop for students providing insights on careers in the pharmaceutical, biotech and manufacturing industry where an exchange of information, ideas and lessons learned can be shared among attendees.  Some key items highlighted include resume reviews by mentors, interviewing skills, professional etiquette, and networking skills.

The event will begin at 7:30 AM and conclude at 5:00 PM.

Lunch and refreshments during breaks will be served.

There will be a $25 charge for the event.

Presented by:
Boston Area Chapter
Delaware Valley Chapter
New Jersey Chapter
New England Chapter

Registration is now closed. If you have any questions, please call the ISPE Boston Office at 781-647-4773. Thank you.

Traveling to INTERPHEX from the Boston area? Sign up for a Complimentary Roundtrip Shuttle Bus.

Buses will depart Boston on March 29 and 30 at 7am. Return trip departs from the Jacob K. Javits Center in NYC at 6pm on March 29 and 4pm on March 30. 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.

The ISPE Boston Area Chapter is once again a proud sponsor of Bio-Ball – a one-day basketball tournament and Special Olympics fundraiser which brings together teams from participating biopharma companies and partners them with Special Olympics athletes.

Brainstorming Session to plan educational content for the 2011-2012 programming season.

SPEAKERS:
Michelle Whipple, Associate Director of QA Validation, Bristol Myers-Squibb
Click here for handouts

Armen Nahabedian, Director, Commissioning/Qualification, Pfizer Global Engineering
Click here for handouts

Eric Felz, Validation Manager, Genzyme Corporation
Click here for handouts

SPEAKERS:
Suzanne Gray: The Entrepreneur's Source
Peter L. Antoinette: Nanocomp Technologies
Dr. Elizabeth Higgins: GlycoSolutions Corporation
Michelle Connor: AdviCoach
Fred Nothnagel: WIND (Wednesday Is Networking Day)
Shelly Henderson: Life Sciences Business Development
Christine Gebski: LIFE Technologies

SPEAKERS:
Tim Alosi, New England Controls, Inc.
Joe Kauten, Lonza Biologics, Inc.
James Heimbach, Lonza Biologics, Inc. 

Click here for Tim Alosi's Presentation

Flat Top Johnny's, One Kendall Square, Cambridge, MA

Charitable Organization: Helping Our Troops (H.O.T.)
Adopt-A-Box Program
 

For the second year in a row, ISPE Boston Area Chapter wins the Platinum Grand Award for Excellence and Innovation

The Certified Pharmaceutical Industry Professional™ (CPIP™) Study Group

Schedule: Study classes start on Tuesday, December 7^th and will run from 6 to 9 pm. The sessions will follow on 12/14, 12/21, 1/4, 1/11, 1/18, 2/1, 2/8, 2/15, 3/1, and 3/8. These dates will lead up to, and help prepare for, the spring exam period March 7 – April 15.

PANELISTS:
Anthony C. Bevilacqua, Ph.D., Mettler-Toledo Thornton
Christopher S. Corsetti, Genzyme Corporation
Bob Livingston, Arion Water, Inc.
Rick Kotosky, P.E., Organogenesis, Inc.

MODERATOR:
Brian Hagopian, Independent Consultant

Flat Top Johnny's, One Kendall Square, Building 200, Cambridge MA

To register: Please email the office at ispe@camihq.com

Location: Genzyme Corporation, 49 New York Avenue (the new Genzyme Science Center), Framingham, Massachusetts 01701

Group Leaders: Joyce Chiu, CPIP, Allan MacDonald, CPIP, John Spohn

SPEAKERS:
Dr. Angela Lewandowski, Process Scientist, Genzyme
Niall Johnson, Owner, Johnson Project Consulting LLC - Click here for Niall Johnson's Presentation

SPEAKER:
David Mark Fourman, Unify Consulting
Please click here for handouts

Tommy Doyle's Pub and Restaraunt
1 Kendall Square, Cambridge, MA 02138

Speakers:
Stephen Reich, Risk Management Principal, Global Quality, Pfizer
Kristin Murray, Senior Manager, Global CMC Regulatory Affairs, Pfizer
Theresa McCarthy, Past Chair, American Society of Quality Boston Section
Randy Perez, PhD, Director, IT Risk Management and Compliance, Novartis Pharmaceuticals 

Keynote Address: Shire HGT--An Overview of the Company, Production Platform, and What’s Ahead for the Future by Dr. Sylvie Gregoire, President, Shire HGT will deliver the Keynote Address

Teddy Ebersol's Red Sox Field, Embankment Rd, Boston, MA

Boston Belle Charters, Marina Bay, 333 Victory Road Quincy, MA 02171-3111

Panelist:
James Blackwell, PhD, Senior Consultant, BioProcess Technology Consultants, Inc
John (Jack) Prior, ScD, Senior Director of BioProcess Engineering, Genzyme
James Dean Vogel, PE, Principal, BioProcess Facilities Services
Larry Weiner, Director of Manufacturing Engineering & Validation at Biogen Idec

The panel discussion will be moderated by Dick Priester, Principal, Strategic Facility Planning LLC

The Chapter will hold its Annual Golf Tournament at the Ferncroft Country Club 

Schedule:
6:30-7:30 AM - Registration and Continental Breakfast
7:30 AM - Shotgun STart - Scramble Format
12:30-2:30 PM - Reception/Cocktails/Buffet Lunch

Cost:
$1,000/Foursome
Continental Breakfast, Lunch, and Golf are included for each player

LOCATION:
Millipore Corporation, 80 Ashby Road, Bedford, MA 01730

SPEAKERS:
David Newman - Senior Director, Global Sustainability, Millipore Corporation
Paul Lukitsch - WW Energy Manager - CEM / Regional Facilities, Manager Millipore Corporation

Please click here for handouts

Hard Rock Cafe, 22-24 Clinton Street, Boston, MA
6:00 pm to 10:00 pm; Improv Show starts at 8:00 pm

SPEAKERS:
Bob Steininger, Acceleron Pharma
Paul Slaman, Shire HGT
James Vogel, Process Facilities Services, Inc.
Pharrish M. Galliher, Xcellerex, Inc.

Click here for handouts

Bridging the Gap between laboratory research and Industrial Applications

MIT Speaker:  Prof. Bernhardt L. Trout, Massachusetts Institute of Technology
Fraunhofer CMI Speaker:  Dr Anirban Chatterjee, Fraunhofer CMI

Click here for Dr. Anirban Chatterjee's handouts
Click here for Prof. Bernhardt Trout's handouts

SPEAKER:
David March, Rockwell Automation

Click Here for Handouts

SPEAKERS:
Peter Harris, B & V Testing
Larry Zanko, STERIS Corporation

Click Here for Speaker Presentations

SPEAKERS:
Carol Bergeron Bergeron Associates
Linda Trowbridge Change Dynamics
Bob Vear Change Dynamics

Dr. Michael Drues, PhD, President, Vascular Sciences
Click Here for Speaker Presentation

At the ISPE Annual Meeting in San Diego, the Boston Area Chapter was awarded the top honor, the North American/South American Affiliate Council "Platinum Grand Award for Excellence and Innovation." Help Celebrate the Success of YOUR Chapter!

Speakers:
Don Kiepert, President & CEO, Lantheus Medical Imaging
William Dawes, Vice President, Manufacturing & Supply Chain, Lantheus Medical Imaging

If you consider yourself a "Young Professional" then you should attend this networking event on the Boston Waterfront. This is a great opportunity to network and a chance to learn and meet the members of the newest group within ISPE Boston; the Young Professionals (YPI). The YPI purpose is to expand the participant's knowledge and professional development through education, seminars and networking.

Boston Beer Works, 112 Canal Street, Boston, MA 02114

Click here for the speaker presentations:
Mary Viola Presentation

Sam Liggero Presentation

Speakers:
Lou Traglia, Commissioning Agents Inc.
Kevin Lynch, Shire Pharmaceuticals

Presentations
Partnering with Larger Companies
Pete Latham, Co-Founder, President, BioPharm Services US
Click Here to Download the Presentation

Contract Manufacturing
Susan Dexter, Principal Consultant, BioPharm Services US
Click Here to Download the Presentation

Speaker:
T. Alan Hatton, Massachusetts Institute of Technology

Presentations:

Process Validation Guidance
Robert E. Chew

The Good, The Bad and The Ugly on Implementing a New Approach
Robert L. Smith Presentation

Presentations:

Leed Certification Overview
Susan Dieker, LEEP AP, Interior Design

Realizing the Value of LEED
Fred Doherty, Certified Energy Manager and LEED AP

18 November 2008

Keeping It Clean - Sanitary Pumps 101

Springhill Suites by Marriott
27 Andrews Parkway, Devens, MA 01434

Presentations:

Centrifugal and Positive Displacement Pumps for Hygienic Applications
Allen LeBoeuf

5 November 2008

Biotech to Bio-fuels
Gateway Center, WPI Worcester Campus

Presentations:

Gateway Park

Biofuels: Ethanol for The Future
Christopher McPhee

8 October 2008

Product Show and Seminars
Gillette Stadium
Foxborough, MA

Seminars on:

• Automation
• Chromatography
• GAMP
• Leadership
• Mixing
• Project Management
• Pumps

Presentations:

Fluid Mixing in Biotech and Pharmaceutical Applications
Kevin Eisert & Susan Sargeant

Rotary Lobe Pumps: When Good Pumps Go Bad
Ron Holly

16 September 2008

Six Sigma Part II: Key to Efficient Innovation & Cost Effective Manufacturing Process

Genzyme Center
500 Kendall Street, Cambridge, MA 02142

Presentations:

North Haven Group, LLC: Design for Six Sigma The Key to Efficient Innovation

Phillip Werth: Use of Statistical Quality Control to Improve the Productivity and Quality of a Biopharmaceutical Process

18 August 2008

“Duffers Only” Golf Outing
Ferncroft Country Club
Middleton, MA 

17 June 2008

“You want it when?!? - Insight from corporate quality and facilities on how to plan, organize, and execute the aggressive construction schedule for your GMP facility.”

Royal Sonesta, Cambridge, MA

Presentations:

Charles Pappalardo: Accelerating Advanced Infrastructure Delivery

Michael Marino, Sr. QE: Controlled Environment Commissioning and Qualification “Using a Phased Approach to meet schedule demands”

11 June 2008

Summer Social

Boston Beer Works

20 May 2008

Water Seminar: From Water 101 to Ozone Sanitization 
Tuesday, May 20, 2008
The Royal Sonesta Cambridge
5 Cambridge Parkway, Cambridge, Massachusetts 02142

Presentations:

Brian Hagopian: Water Purification 101

Bob Livingston: Best Practice for the Use of Ozone in Life Science Applications

22 April 2008

Quality vs. Engineering: A Love-Hate Relationship
Genzyme Science Center
49 New York Avenue, Framingham, Massachusetts 01701

Presentation:

If looks could kill… No work would get done
Greg Ruklic

18 March 2008

Regulatory Seminar
Biogen Idec
Cambridge, MA

11 March 2008

PlantTour
Millipore
Bedford, MA

7 March 2008

Ski Trip

13 February 2008

February 13, 2008 - Joint Meeting with MIT
Royal Sonesta
Cambridge, MA

"Continuous Improvement in Biologicals Manufacturing: An Opportunity for Process Analytical Technology"

January 15, 2008

“It’s all in the DOCS; Planning CTD/eCTD CMC Submissions”

The Royal Sonesta Cambridge
5 Cambridge Parkway, Cambridge, Massachusetts 02142

January 10, 2008

New Year’s Social
One Kendall Square, Building 200
Cambridge, MA 02139

17 October 2007

16th Annual Product Show
Gillette Stadium Clubhouse, Foxborough, MA

10-13 September 2007

2007 ISPE Boston Classroom Training Series
Focus: Isolation Technology

30 July 2007

ISPE 5th Annual Golf Tournament
Granite Links Golf Club, Quincy, MA

19 June 2007

Joint Educational program Boston Area Chapter and New England Chapter
"The End of Validation as We Know It: A Science and Risk Based Approach to Commissioning and Qualification"
Speaker: David E. Petko, P.E., Director Engineering and Design, Johnson & Johnson

Download the presentation from this event

15 May 2007

Seminar: “What’s the Deal with Stainless Steel?”

10 May 2007

Facility Tour: COTTER BROTHERS CORPORATION

March 2, 2007

Annual Ski Trip, Loon Mountain, NH

February 27, 2007

Best Practices: Commissioning and Qualification, Abbott Bioresearch Center, Worcester, MA

January 16, 2007

Six Sigma Methodology & its Application in the Bio-Pharm and Healthcare Industries, Royal Sonesta, Cambridge, MA

7 December 2006

Holiday Social and Toys for Tots Event 
Flat Top Johnny’s Billiards
One Kendall Square, Building 200
Cambridge, MA 02139

October 18, 2006

2006 ISPE Boston Pharma Product Show
Gillette Stadium Clubhouse, Foxboro, MA.

September 26, 2006

Cleaning Equipment Design, Chemistry and Operations for Pharmaceutical and Biotech, Royal Sonesta, Cambridge, MA

August 17, 2006

Golf Tournament, Granite Links, Quincy, MA

May 23, 2006

Water, water, everywhere, but nary a drop to drink, The Royal Sonesta Cambridge
5 Cambridge Parkway, Cambridge, Massachusetts 02142

March 9, 2006

Nanotechnology, No Small Matter, The Royal Sonesta Cambridge
5 Cambridge Parkway, Cambridge, Massachusetts 02142

March 3, 2006

ISPE Annual Ski Outing, Loon Mountain, NH

January 30, 2006

Real-Time Quality in Manufacturing and Just-in-Time Validation, The Royal Sonesta Cambridge
5 Cambridge Parkway, Cambridge, Massachusetts 02142

December 7, 2005

Annual Holiday Social and Toys for Tots Event
FELT, Boston, MA

November 16, 2005

Massachusetts Biologic Laboratory Plant Tour
Mattapan, MA

October 25, 2005

Annual Product Show
Keynote Speaker - Lt. Governor Kerry Healey

September 27, 2005

Talking Shop: "That's Exactly What I Asked For, But It's Not What I Want"
Developing Better User Requirement Specifications (URS)

August 18, 2005

Golf Tournament

June 27, 2005

Talking Shop
Sterile & Aseptic Process Vial to Vial

June 28, 2005

Phoenix Controls Facility Tour

April 20, 2005

Educational Seminar
"What do you do when the lights go out?" - Critical Power and Utilities,
Location: Royal Sonesta, Cambridge, MA

March 30, 2005

Talking Shop
Tech Transfer - What's the big deal?
Location: Biogen Idec, Cambridge, MA

March 4, 2005

Annual Ski Trip, Loon Mountain, NH

Feb 10, 2005

Problems and Operational Nightmares: 10 Years Later
Royal Sonesta, Cambridge, MA

Jan 13, 2005

Taking the Risk out of Risk
The Royal Sonesta Cambridge

Dec 9, 2004

Annual Holiday Social and Toys for Tots Benefit
The West Street Grille
15 West Street, Boston, MA 02111

Nov 9, 2004

Product Show
Newton Marriott

October 19, 2004

Talking Shop: F.A.T.
Biogen Idec Cambridge
15 Cambridge Center
Cambridge, Massachusetts

Sept. 14, 2004

Utility Systems: How do you make your WFI?
The Royal Sonesta Hotel - Cambridge
5 Cambridge Parkway
Cambridge, Massachusetts

Oct. 5, 2004

Equipment Specification/JETT Workshop
The New Boston Convention Center
415 Summer Street
Boston, Massachusetts

Aug. 12, 2004

ISPE Boston Area Chapter 2nd Annual Golf Tournament
Cyprian Keyes Golf Club
284 East Temple Street
Boylston, Massachusetts

June 30, 2004

Talking Shop
Abbott BioResearch
100 Research Drive
Worcester, Massachusetts

May 13, 2004

ISPE Boston Area Chapter
Plant Tour and Educational Program
AstraZeneca R&D Boston Facility Tour

Mar 5, 2004

Annual Ski Trip
Loon Mountain, New Hampshire

Feb 17, 2004

Educational Program and Plant Tour:
Alkermes® Brickyard Square Facility

Jan 8, 2004

Educational Program: Mycoplasma Removal, and Liquid Nitrogen Filtration -- It's all about Sterility

Dec 3, 2003

Social Program: Holiday Party

Dec. 9, 2003

Lonza Tour: Commuter Series: Facilities Program and Plant Tour Pay Me Now or Pay Me

Sep 25, 2003

Educational Program: Disposable Technology

Aug 12, 2003

1st Annual ISPE Boston Area Chapter Tournament

May 1, 2003

Plant Trip to Wyeth on "Biotech and Big Pharma"

Apr 10, 2003

Contract Manufacturing

Mar 31, 2003

ISPE Boston Chapter presents workshops at INTERPHEX

Mar 7, 2003

Annual Ski Outing, Loon Mountain, New Hampshire

Feb 25, 2003

The Changing Face of Pharmaceutical High Purity Water

Jan 8, 2003

Emerging Downstream Technologies

Dec 5, 2002

Annual Holiday Party and Toys for Tots benefit

Oct 29, 2002

"Pre-Approval Inspections - Everything You wanted to Know but were Afraid to Ask"

Oct 2, 2002

Modular Construction - A Technique for accelerated project delivery for full-scale production Biotech Facilities