Education Tracks
Choose sessions from as many tracks as you like to customize your learning experience.
Download the education handouts (registered education delegates only)
Throughout this site we identify tracks by color:
| Regulatory (100) | Investigational Products (500) |
| Innovation (200) | Project Management (600) |
| Manufacturing Operations (300) | Efficient and Effective Compliance (700) |
| Engineering Design (400) |
Regulatory (100)
This track has critical information for all facets of our industry. Regulatory issues, changes, and uncertainties pervade the industry. This year’s Regulatory track will focus on specific regulatory topics:
- Product Quality Lifecycle Implementation (PQLI) seeks to define a practical approach to global implementation of ICH documents. Attend the PQLI Global Updates Parts 1 and 2 to get the latest information
- Risk-MaPP addresses the use of risk-based techniques for managing cross contamination risks - the new ISPE Risk-MaPP Guide is imminent
- PAT application has matured, and discussion and case studies can move implementation of PAT forward as delegates learn from each other through case studies and discussion
- Biosimilars provides a forum for debating the issue from multiple perspectives to facilitate the creation of a regulatory pathway for product approval
- Quality control laboratories also face continuing challenges, learn the latest on some of these as well as an update on the development of this ISPE Guide
Track Program Chair
- Rebecca Waterbury, Regulatory Compliance, Abbott Vascular, USA
Education Sessions in this track
Innovation (200)
Our increasingly competitive environment, with its associated focus on improving operational efficiency and reducing cost, led us to be dissatisfied with incremental improvements. In seeking new methods of solving problems, we wish to create major gains in our own operations. One good way to innovate is to look at how others in our industry have or are planning to solve these problems. This track will look at several of the hot areas where major innovations are taking place.
All of the sessions in this track will make you think, will provide new perspectives, or provide new information. In this track, we address continuous and high throughput as well as downstream processing, science in technology transfer, and developments in vaccines and the field of nanotechnology. If you want to learn about the innovations taking place in the pharmaceutical industry, this track is for you.
Track Program Chair
- Michael Denault, Principal, Denault Associates, USA
Education Sessions in this track
Manufacturing Operations (300)
Manufacturing operations face challenges from multiple fronts:
- A vastly expanded global marketplace
- Increasing pressure on manufacturing efficiency to remain competitive in the world market
- Outsourcing
- New developments in barrier isolation and aseptic processing
This track offers sessions on all these challenges linked with topics on achieving manufacturing excellence and a specific focus from a supplier’s perspective on emerging global opportunities. You will participate in sessions that are global, innovative, include generics, contract manufacturing, and issues important to big pharma. Attend this track to:
- Hear ideas that will expand your views
- Meet key players with broad perspectives that will challenge you to think creatively
- Participate in discussions and share your perspectives
- Take advantage of the vast experience represented by fellow delegates
This track will address both strategic and tactical issues, and will therefore be of interest to all levels, including executive level participants who need an ever-expanding range of views to make informative decisions.
Changes in the manufacturing environment as we know it are already occurring. This track presents the details that enable you to make the most informed decisions. Be informed on how you will be affected and on how to formulate the best course of action.
Track Program Chair
- Cheryl Tucker, Alliance Management, Eli Lilly & Co., USA
Education Sessions in this track
Engineering Design (400)
Engineering Design has always played a critical role in the complex and challenging field of drug products manufacturing, starting from facilities design, through construction and qualification of new and refurbished installations, and ending up in the successful operational functions of those centers of production. By attending this group of sessions, facility owners/users, design service providers, planners, project managers, process/utilities engineers, and plant operating personnel will benefit by understanding and/or expanding their knowledge of many key subjects, including:
- The working details of specific systems in the transfer technologies field, options in the selection of equipment, and analysis of competing systems
- Facilities retrofit design processes, the available choices between retrofitting and new construction, and construction logistics planning
- Project presentations by each one of the Category Winners of the Facility of the Year Program (FOYA) for 2008
- Energy reduction techniques for critical utility applications, and comparison with new more efficient water and pure steam technologies
- Identification and description of new and developing equipment construction standards and current trends in their generation
- Understanding the function and importance of Kilo Labs and Pilot Plants, in addition to cost and scheduling of related projects
This will be a unique opportunity to see and hear in a few hours what the experts in the various fields described above have devoted many years developing and improving through application of innovation, and response to the demands of a truly dynamic industry. The topics examined in this track will provide additional benefits to the attendees, such as some “heads-up” on developing technologies and techniques, as well as practical approaches to problem solving and identification of challenges. Join us for a very enriching professional learning experience.
Track Program Chair
- Michelle Gonzalez, Retired, Amgen, Inc., USA
Education Sessions in this track
Investigational Products (500)
Participate in a dynamic track with a focus on innovation and strategic partnerships. Find out about industry success stories and increase your ability to deliver today and tomorrow. Share in the discussion of ‘hot topic’ issues facing Investigational Products (IP) professionals. Hear from industry experts on topics such as:
- Protocol interpretation
- Comparator strategies
- Developing successful partnerships
- Business project management
- Updates on current regulatory issues
Track Program Committee
- Michael Arnold, RPh, Business Process Head, Global Supply Chain, Pfizer Inc., USA
- Michelle Foust, PharmD, Director New Product Development, Almac Clinical Services, USA
- Neal Gordon, Senior Director CMC-USA, Organon a part of Schering Plough Corporation, USA
- Kunal Jaiswal, Planning Committee Chair, Associate Director, Clinical Supplies, Schering-Plough Company, USA
- Paula Mastrangelo, Associate Director, Bristol-Myers Squibb, USA
- Robert Pizzie, PhD, Senior Director Global Clinical Supply Planning, Schering-Plough, USA
Education Sessions in this track
Project Management (600)
In order to meet the demand to deliver projects and programs on an accelerated schedule, effective application of project management methodologies is critical. Participate in this interactive track to analyze current real-world, applied innovations in project delivery, and take advantage of valuable insights from industry experts discussing how current and future trends can be used to transform current projects, and help shape future project success. Participate in discussions on successful project execution on a wide variety of project types. This innovative track will help new or veteran project managers improve their performance, and establish valuable knowledge to further their job success and career goals.
Track Program Chair
- Keith Gibbs, Corporate Manager Technical Services, C&Q, Yonkers Industries, USA
Education Sessions in this track
Efficient and Effective Compliance (700)
This track brings some key new guidance and standards from the 50,000 ft level down to real world implementation. It will help attendees by providing practical application of the new guidance and compliance standards which have emerged in the last year. Sessions will address Project Information Management (PIM), ASTM E2500, GAMP®5, ICH Q9 and the C&Q companion guide in progress.
It stresses efficiencies, which may be gained by adopting the new practices, and includes new, more efficient, risk-based concepts in play for focusing the efforts in qualifying or verifying systems.
Presentations will include case studies and interactive workshops to promote deeper understanding of both the advantages and pitfalls of the implementation of the concepts under discussion. Sessions will provide practitioners with tools and techniques to apply and manage the information in cooperation with vendors, engineering and validation to effectively deliver fit-for-purpose systems with minimal duplication of effort. The sessions are structured to provide an opportunity to:
- Benchmark your practices against peer companies’ practices
- Identify better ways of working
- Avoid wasted and duplicated efforts
- Leverage tasks to meet multiple goals
- Understand how these new ideas can pay off in many ways including improving the bottom line
Sessions will benefit new practitioners to seasoned professionals.
Program Chair
- James John, Project Lead, Altus Automation, A ProPharma Group Company, USA