CSC: 21 CFR Part 11 - Procedural and Technology Requirements

Now that the FDA has tentatively narrowed the scope of 21 CFR Part 11, What is your strategy? How can you benefit? This conference will address both the procedural and technological aspects of 21 CFR Part 11. The technological aspects are addressed more frequently, however, no computer system can be compliant unless these procedures are addressed. Speakers will discuss the latest interpretation of 21CFR Part 11 along with computer system compliance strategies.

Why Attend?	Overview of 21 CFR Part 11 Compliance Tips & Techniques Risk-Based Strategy Control System Documentation Get multiple viewpoints and solutions Biometric Applications Security Issues Audit Trails 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 for abstracts of the Presentations. Click here for Conference Brochure
Schedule	Conference & Exhibit: 5 November 2003 Registration: 7:30 a.m. Presentations: 8:00 a.m. - 5:00 p.m.
Registration Information	Your fee includes admission to the conference & exhibit on 5 November. Includes complimentary coffee breaks, lunch and 7 PDHs – Professional Development Hours used to earn and maintain certifications. ISA Members: $295; Non-Members: $345; Group: $275.00  Register Online Download registration form Call ISA Customer Service (919) 549-8411
Product Showcase	The conference will be held in conjunction with a tabletop product showcase. To participate as a vendor in this showcase, please contact: Orlando Metcalf  at 919-990-9383 or ometcalf@isa.org
Past Exhibitors	ABB Endress + Hauser Eutotherm GE Pharmaceuticals Iconics Intellution MAVERICK Technologies Propack Data SAFELINK Corp SMAR International Stelex Valspec Yokogawa
Area Hotels	La Quinta Inn and Suites Raleigh Research Park 1910 West Park Drive, West Park Corporate Center Durham, North Carolina 27713 Phone: 919-484-1422 Fax: 919-484-1423 Clarion Hotel @ Research Triangle Park 4912 South Miami Boulevard Durham, NC 27703 Phone: 800-252-7466/ 919-474-9800 Wyndham Garden Hotel 4620 South Miami Boulevard Durham, NC 27703 Phone: 919-941-6066 Holiday Inn Raleigh-Durham 4810 Old Page Road, I-40 and Exit 282 Old Page Road Research Triangle Park, NC 27709 Phone: 919-941-6000 Radisson Governors Inn I 40 Exit Davis # 280 Durham, NC 27709 Phone: 919-549-8631
Local Information:	Weather Forecast Area Attractions About Research Triangle Park

For speaking and exhibit opportunities, please contact: Orlando Metcalf at 919-990-9383 or ometcalf@isa.org

For Conference registration: