Red Level Suites, East Clubhouse
The Boston Area Chapter Educational Program Committee works hard to develop a cutting-edge innovative education program each Product Show year. They are working to create a portal for interested speakers to submit their presentation proposals and more information will be posted on that soon. In the meantime, feel free to email your proposal to email@example.com.
Interested in what has been presented in the past? Below is a list of our 2017 educational sessions and speakers.
11:30 am – 1:00 pm
Quality Risk Management: Iron Chef Edition
Every product or process has associated risks. Zero risk may not always be an attainable goal nevertheless; protection of the patient by managing risk in the quality system (Quality Risk Management or QRM) and manufacturing process is being given prime importance in the pharmaceutical industry. Traditional risk assessment tools are being replaced by recognized risk management tools along with the support of statistical analysis. However, QRM systems that rely on input from more than a well-trained and practiced group often introduce risk to the product by not allowing for demographically scaled training. This highly interactive, audience participation, role-play style experience will take the complexities of Quality Risk Management programs and break them down into their basic ingredients. We will than combine those ingredients to understand QRM as it applies throughout the project lifecycle, and across the project team demographic, from supplier to end-user.
Speaker: Keith Gibbs | Kage and Sui Generis | Ninja Project Management
Keith Gibbs is the kage1and sui generis2 at Ninja Project Management, Inc. He is a highly motivated leader with a proven project management record of accomplishment. Able to interface with and motivate people at all levels of an organization or project and across all business units, he works diligently on the application of best practices. He possesses an extensive experience organizing and supervising the business activities of project teams, within budget and to tight timetables. An innovative thought leader who is well respected by industry peers for creative and applicable solution
s to complex problems, he has proven planning and brainstorming expertise that has established a framework for successful projects and business practices. The kage3 is a sought after trainer and educator who has a gift for motivating fellow professionals to reach their peak performance. Through many years of in the field experience, he possesses a full and applied understanding of the business of consultancy support to industry. An extract from his FBI file reads, “REDACTED”.
1 A kage oversees the activities of their village, from sending ninja on missions to making the hard decisions regarding the safety of their people.
2 Latin, meaning one of a kind
3 A village’s kage is generally acknowledged as its most powerful ninja.
1:30 pm – 3:00 pm
Biotech 101…An Engineer’s Guide to the Biomanufacturing Galaxy
What drives biomanufacturing process and facility design today? How are QbD, Risk-based Design, Enabling Technologies, and Innovation driving the focus of the Industry? This program will present an introduction to some basic principles of biomanufacturing and the relationship between modern day biological science and its application to commercial manufacturing of therapeutic products. We will then begin to peel back the layers of design requirements through the eyes of the Engineer and focus on product-process-facility attributes and their relationships to each other. From there the journey will move into the importance of risk identification and management, both from a regulatory and business operations viewpoint. As the Industry has advanced technology, what are the basic drivers of “enabling innovation” as it is being applied to biomanufacturing? We will explore innovation driving agility and flexibility and the basic goals of how the Industry is defining future manufacturing capabilities.
Case study examples and interactive participation of the audience will help move the discussion through the fast-paced journey. At the end of this journey attendees will have new tools for their toolbox, a broad understanding of how the Industry is changing and evolving, and an overview of how companies view their biomanufacturing operations.
Speaker: Jeff Odum, CPIP | Managing Partner and Global Technology Partner | NNE
Jeff Odum is the Managing Partner, Strategic Manufacturing Concept Group, and a Global Technology Partner at NNE in the US Office located in Durham, North Carolina. He has over twenty-five years of management experience in the design, construction, and commissioning of facilities in the process, biotechnology, and pharmaceutical industries.
A recognized expert in biopharmaceutical manufacturing, Mr. Odum has authored over seventy articles and four Industry reference books on subjects related to GMP compliance, process improvement, and the design and construction of biopharmaceutical manufacturing facilities. He is a welcomed speaker at numerous international industry forums and conferences, presenting on topics relating to next generation facility design, bioprocess manufacturing, project management and GMP compliance. Mr. Odum, a Certified Pharmaceutical Industry Professional (CPIP), served as the North American Education Advisor to the International Society of Pharmaceutical Engineering (ISPE), is a member of the ISPE Biotechnology Community of Practice Steering Committee, and a contributing author to numerous industry baseline and reference guides focused on biotechnology manufacturing, process development, project management and commissioning and qualification. He is a member of the PDA and ISPE technical training faculties and is a Teaching Fellow in North Carolina State University’s BTEC graduate program in biomanufacturing and a Guest Instructor for the North Carolina Community College System BioNetwork Program. He has led training efforts in fifteen countries, including training for global regulators from the US FDA, Health Canada, and the Chinese SFDA.
3:30 pm – 5:00 pm
Take the Guesswork out of your Lab/Pharma Water System
This will be an “interactive” introductory to intermediate level session providing attendees with a basic understanding of water purification and then involving the audience in dealing with several common misconceptions about water purification, control of bacteria and biofilm, and how to verify water purity (we are in a regulated industry, you know!).
We’ll start with the basics to get everyone on the same page. Water is the most commonly used material used in the manufacture and purification of many biotech and pharmaceutical products and medical devices. Water may an ingredient, a solvent, a diluent, a cleaner, or for any one of many other purposes. It is important to understand why water needs to be purified and how dozens of different purification steps can be integrated to get the right water purity for its intended use. This presentation will start by reviewing the contaminants/impurities that exist in the incoming water supply and provide the attendee with an understanding of why some of these materials need to be removed (while others don’t) based on the intended use of the water. We will touch on different grades of water as identified by various pharmacopoeias and consensus standards (ASTM, CAP/CLSI, pharmaceutical, and microelectronics grades). Attendees will receive a broad overview of why different grades of water purity exist.
After everyone has the basics, we can start the fun and interactive stuff: We’ll involve the audience by making a series of statements and questions (or will they be mis-statements and questions?) to uncover some of the most common misconceptions about water purification, monitoring, sampling, bacteria, etc. Come ready to learn and have fun at this session!
Speaker: Brian Hagopian, CPIP | President | Clear Water Consulting, Inc.
Brian Hagopian, CPIP received his degree in chemistry from Colgate University a long time ago and is currently the President of Clear Water Consulting, Inc. Brian has over 35 years of design, manufacturing and operational experience and is a high purity water subject matter expert, consultant, trainer, educator, and expert troubleshooter to help clients solve complex operational problems, assess risks, and address compliance observations. Brian is an instructor at Worcester Polytechnic Institute’s Biomanufacturing Education and Training Center and is also a Massachusetts certified instructor offering courses for the licensing of industrial wastewater operators. Brian is a charter member and Past President of the Boston area chapter where he helped to lay the foundation for the Boston Chapter’s highly successful Product Show, which has won two International awards for “Best Special Event” at ISPE Annual Meetings. Brian is one of six people to have received the Hank Moes Lifetime Achievement Award for significant contributions to the Boston chapter and the life sciences industry and is one of 150 people worldwide to have attained the Certified Pharmaceutical Industry Professional (CPIP) certification, conferred by ISPE in 2012. Brian has the Boston Chapter’s Student Development Committee for the past six years where student membership has quadrupled and the number of student chapters have doubled through his efforts. Brian has been an active member of the ISPE Critical Utilities COP Steering Committee where he has just completed leading a team of 20 subject matter experts in the publication of the ISPE Good Practice Guide on Sampling of Critical Utilities in December, 2016.