Education for changing times in the pharmaceutical industryBy Kevin RichardsIndustry Vice President, Reed ExhibitionsIt’s hard to imagine an industry more dynamic-or more demanding-than pharmaceutical manufacturing. And current trends promise that there will be no letup in the challenges facing pharmaceutical companies. In fact, in view of the FDA’s new risk-based initiatives, the entire industry is now in the midst of a revolution that is radically changing approaches to both the manufacturing process and how it is regulated. As a result, it is more vital than ever to keep up to date with the latest technical advances and changes to the regulatory environment.
The PharmaManufacturing Conference at INTERPHEX2004 is designed to help you do just that. This timely program, developed by ISPE, features mission-critical topics including quality control, validation, PAT, compliance and facilities that are at the top of the agenda for today’s pharmaceutical manufacturing professionals. In addition to learning how to deal more effectively with core manufacturing issues, conferees will discover proven methods to help ensure regulatory compliance, optimize manufacturing resources, and implement current good manufacturing processes.
Conferees can select from 29 sessions in a variety of interactive formats, including one-hour technical sessions, case studies and open forums to discuss ISPE’s new Baseline(r) Guides, plus several longer, in-depth workshops. Also, for the first time this year, the conference features a unique, highly focused learning opportunity for those whose job requires a detailed understanding of pharmaceutical water systems. These four related sessions, developed by the ISPE New Jersey Chapter, discuss where water is used in the pharmaceutical industry, water system planning and design, water quality standards and much more.
Manufacturing operations sessionsIn today’s pharmaceutical industry, current good manufacturing practices are no longer likely to remain unchanged for long! Process and manufacturing engineers who want to be aware of current best practices can participate in a variety of cutting-edge sessions including the JETT Consortium’s review of GAMP requirements; ISPE’s Active Pharmaceutical Ingredient Guide and revision of the Sterile Manufacturing Guide; operational benchmarking, process analytical technology and more.
Facilities design and planning sessionsFacilities and design/construction personnel will find a wealth of resources in this year’s agenda-including a case study of a large-scale build-out project; cost-effective strategies for designing R&D laboratories; pharmaceutical HVAC system design; designing containment systems for potent compounds; adapting existing office buildings for biotech research, and much more.
Quality Control, validation and compliance issuesThe FDA’s recent endorsement of process analytical technology (PAT) in pharmaceutical manufacturing poses significant new challenges to validation and quality control professionals. At the same time, the industry is under increased regulatory scrutiny, and the FDA plans to step up inspections of facilities in certain high-risk categories. Find effective strategies for meeting these and other challenges in sessions on PAT; CIP cycle development; multi-site validated systems; sterilization validation; and integrated commissioning and validation of mechanical systems.
Biopharmaceutical perspectivesCollaborations between pharmaceutical manufacturers and biotech companies are increasing, and this fact is reflected in this year’s conference program. Nearly a dozen sessions focus on challenges facing biopharmaceutical manufacturers, while also providing valuable insights for their colleagues in small molecule development. Topics include operational benchmarking; adapting existing office buildings for biotech and research use; FAT case studies; and ISPE’s Biopharmaceuticals Guide, among others.
Skill-building sessions that offer real-world solutionsConferees will have an unprecedented opportunity to “pick the brains” of technical experts, and come away with the skills required to implement what they’ve learned. Speakers include experts from ISPE, the JETT Consortium and the American Institute of Architects, as well as leading companies including Cambrex BioScience; Commissioning Agents Inc.; Eli Lilly; Hoffmann-LaRoche; Integrated Project Services; Lonza Biologics; Millipore Corp.; Syska Hennessy Group; TEFEN USA; Turner Construction; Wyeth BioPharma and others.
FDA Keynote: A Discussion with Dr. Janet WoodcockThe conference will open with an unprecedented keynote presentation featuring Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER), FDA. This unique and timely panel discussion, moderated by Justin O. Neway. PhD, Executive Vice President and Chief Science Officer of Aegis Analytical Corporation, will provide insight into the implications of the FDA’s new risk-based initiatives.
Outsourcing conference also being held at INTERPHEXThe PharmaSourcing & Services Conference, which focuses on the latest trends and developments in the pharmaceutical outsourcing arena, will take place on Tuesday, March 16. It is also produced by ISPE, the Society for Life Science Professionals, and will feature a “state of the industry” keynote by James Miller, Founder and President, PharmaSource Information Services. For complete details visit http:www.interphex.com.
Continuing education creditsISPE will provide continuing education units (ISPE CEUs) for the PharmaManufacturing Conference. ISPE CEUs are nationally recognized units of achievement that have been designed to identify those individuals who continue their education in their chosen field or profession. CEUs are also available for selected sessions through AIA and the Florida Board of Professional Engineers. Please visit www.interphex.com for details.
About the eventPharmaManufacturing at INTERPHEX provides a close-up look at everything that’s new and innovative in the world of pharmaceutical manufacturing. INTERPHEX, the largest and longest-running pharmaceutical industry event, will take place March 16-18, 2004 at the Jacob K. Javits Convention Center in New York City. For complete show and conference information as well as convenient online registration, visit www.interphex.com.