21 CFR 11 & GMP Compliance Technical Conference

Tuesday, 9 December 2003 through Wednesday, 10 December 2003

DoubleTree Hotel - San Jose
2050 Gateway Pl
San Jose, CA , United States

The last day to pre-register online was December 9, 2003.

This two day conference will address Regulatory Risk and Reward for both procedural and technological aspects of 21 CFR 11 and GMP. A relaxation of FDA regulations encourages a Risk-Based Approach for compliance. How will this affect quality?...your strategy?...your next audit? This low-cost, high-value conference will provide the technical information and tools you need to interpret the "relaxation" and put solutions into action. In addition, a product showcase exhibit will feature some of the latest technology and services to ease your compliance woes.

Why Attend?
  • Technical and Regulatory Updates on 21 CFR Part 11 and cGMP
  • Risk-Based Strategy
  • Compliance Tips & Techniques
  • Control System Documentation & Procedures
  • Get Multiple Viewpoints and Solutions
  • Security Issues
  • Audit Trails
  • Validation & Quality
  • Highly Interactive - Networking opportunities allow for 1-on-1 interaction with presenters, vendors, and fellow participants. Multi-platform presentations include hardware, software, lectures, and panels.
  • Latest Technology - Product Showcase will further enhance your experience. Tabletop displays will feature compliance software, hardware, publications, services and more.
Who Can Benefit?
  • Pharmaceutical Managers, Designers, or Operators
  • Process Control Engineers
  • Generic Drug Manufacturers
  • Project Managers
  • Validation Engineers, Technicians, Specialists
  • System Integrators
  • Compliance Specialists
  • Information Technology Professionals
  • QA/QC Experts
  • Consultants
  • Installers of PLC, SCADA, DCS or MES in Pharmaceutical Environments
  • Anyone seeking to get a career jump-start on 21 CFR Part 11 or cGMP compliance technologies.
View Presentations

Click here to view abstracts.

Click here to view conference brochure

Hotel Information: DoubleTree Hotel - San Jose
2050 Gateway Place
San Jose, CA 95110
Phone: (408) 453-4000

ISA Special Rate: $109/Night; Cutoff: 17 November 2003

Schedule:

Conference Agenda

Conference & Exhibit: 9-10 December 2003
Registration: 7:30 a.m. Daily
Presentations: 8:00 a.m. - 5:00 p.m. Daily

Rates:

Rates: 2 Day Technical Conference Only-$375.00 Mem; $475.00 Non-mem

Group Rate for 2 Day Conference-$355.00

To Attend

Download Registration Form

Register online

Local Information In the heart of Silicon Valley, San Jose flourishes with industry, beauty and a culture rich with history. DoubleTree Hotel San Jose places you in the center of all of it -- less than a half-mile from San Jose International Airport, 45 minutes from San Francisco International Airport…More information including amenities, maps and directions are available online at the Double Tree - San Jose Website.

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For Conference Registration:

The last day to pre-register online was December 9, 2003.