Interphex Show Preview

March's Interphex Show WIll Kick Off With A Frank Discussion of What To Expect From FDA

 

Instead of the usual keynote address, March's Interphex 2004 Conference and Exhibition will take off with a conversation with Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research (Photo). Entitled "What to Expect from the FDA and How it Will Impact Pharmaceutical Manufacturing," the talk will be part of a panel discussion examining where the Agency is heading and what it will mean for your company, and offer perspectives from some of the leading pharmaceutical and biotech companies, including Abbott, Johnson & Johnson and Amgen.

 

Moderating the session will be Justin Neway, executive vice president and chief science officer of Aegis Analytical Corp. "As the industry landscape increases in complexity and competition, issues such as pricing, generics and compliance stand at the forefront of industry concerns," he says. "In this panel, we will air the views of Dr. Woodcock and four leading manufacturing executives,covering important issues including some of the implications of the FDA's new risk-based initiatives."

Nearly 1000 Exhibitors Expected; Firms Recruiting Onsite

An innovative program is only one of several reasons to attend the 25th annual Interphex show, to be held March 16 through 18 at the Jacob K. Javits Convention Center in New York City. The event will also showcase the latest technologies and products from over 950 exhibitors. Separate product pavilions will exhibit innovations in automation and control, packaging, security and safety, and plant siting. A career expo, sponsored by HireHealth.com and BioSpace.com, will offer opportunities to network and examine career opportunities in pharmaceuticals, biotechnology and healthcare. In fact, many of the industry's leading companies will be on-site interviewing at the show. Baxter Pharmaceutical Solutions, with Interphex's producer, Reed Exhibitions, is also sponsoring a contest, open to all attendees, offering a MINI Cooper (photo) as prize.

Four-pronged Program Has Something for Everyone

March's Interphex program will feature four concurrent conference tracks focusing on manufacturing, outsourcing, IT and discovery, developed and produced by the Society of Life Science Professionals (ISPE).

  • A one-day technical conference will focus on improving manufacturing, featuring such topics as benchmarking, ensuring FAT success, and optimizing building system design and engineering.
  • A second ISPE conference, PharmaSourcing & Services, will cover such critical topics as ensuring compliance when outsourcing manufacturing.
  • The PharmaIT program, meanwhile, will look at data integration and management, e-business, supply chain management, logistics and other areas of concern for today's pharmaceutical manufacturing managers. Presenters will include CimQuest, Inc. (Exton, Pa.), which will offer workshops that include "GXP Requirements for the IT Environment," and "Protecting Pharmaceutical Sales and Marketing Practices in An Era of Heightened Enforcement," which will focus on issues resulting from the Prescription Drug Marketing Act (PDMA).

    Professional Development the Focus

    Reflecting this structure will be four concurrent accredited educational programs for the manufacturing professional--short courses conferring continuing education units (CEUs) and presented by ISPE, the Institute for International Research (IIR), and the Center for Professional Advancement. On Tuesday, March 16, courses will include the following:

  • Operational Benchmarking in the Biopharmaceutical Industry
  • Basics of Water Purification (Part 1 of a four-part series that will include Water System Design Planning, Total Water System Design, and Key Design Elements and Case Studies of Pharma Water Systems)
  • Multi-Site Validated Systems: Getting It Right The First Time

    Wednesday courses will include:

  • Pharmaceutical HVAC Systems
  • CIP Cycle Development
  • Commissioning and Validation for Mechanical Systems
  • FAT Case Studies
  • Sterilization Validation
  • Review of GAMP Requirements for Validation
  • PAT

    Thursday will feature an extensive introduction to ISPE's Baseline Guide Series, first published in 1996 as the Bulk Pharmaceuticals Guide, which has undergone an extensive revamp and will now use Active Pharmaceutical Ingredient (API) terminology.

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