2002 East Coast Annual Computer & Software Validation Processes

Venue: Park Hyatt Philadelphia

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Jul 31, 2002 End Date/Time: Aug 02, 2002
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The advent of the Electronic Records and Signatures Rule (21 CFR Part 11) in August of 1997, brought all “paperless” recordkeeping systems under intense regulatory scrutiny. Companies were given a five-year leniency period that expires as of August 2002 and the biotech and pharmaceutical industries are already feeling the effects the FDA’s heavy-handed approach. A number of companies have already been issued 483 warning letters, resulting in an industrywide emphasis on remediation planning and managing the development and validation of regulated laboratory spreadsheet applications. In addition, the FDA is now focusing on a quality systems based approach to pre-approval inspections, mandating that company personnel be adequately prepared to defend its system in the face of an audit.
The Institute for International Research recognizes the universal concern of failing an inspection and needing to, therefore, adequately implement and maintain a validated computer and software system. IIR is proud to present the 2002 East Coast Annual Computer and Software Validation: Ensuring System Compliance with 21 CFR 11.
This conference offers a fully interactive forum, emphasizing a more hands-on and personalized learning experience than in the past. Presenters have designed sessions to encourage interaction among delegates by providing breakout groups designated to solve problems posed through real-life applications. This practical, interactive approach allows delegates to devise goal-oriented solutions to

Making validatable regulated spreadsheet applications and validating existing ones
Implementing change control and remediation programs
Preparing for a quality based systems audit
More specifically, sessions allow delegates to:

Analyze, in detail, the principles of 21 CFR part 11, Electronic Records and Signatures
Prepare a CSV assessment checklist to determine the extent of a planned remediation
Gain hands-on experience with real life scenarios to develop a CSV plan scope
Understand 21 CFR Part 11 issues as they apply to validated spreadsheets
Prepare for the FDA’s quality systems based approach to pre-approval inspection
Examine the primary areas of quality systems to successfully defend against an audit
Learn a practical approach to solving validation problems unique to automated processes based on programmable logic controllers

Janit Buccella of Omnival, Inc., guides delegates through the planning process and execution of a CCV assessment and remediation effort.
John Tsoukatos of Biosite Diagnostics offers practical experience in establishing a validation methodology for automated processes and PLCs.
Erik Reedinger of Schering-Plough Research Institute, suggests strategies for ensuring ongoing compliance with regulatory and functional requirements for off-the-shelf software
David Nettleton, a Computer System Validation Specialist, discusses the fundamentals of implementing Excel(tm) applications for regulated applications in the laboratory.
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Important information about our Pre-conference Workshop!

In this interactive workshop, delegates examine the key aspects of the 21 CFR Part 11 Electronic Records and Signatures Rule including definitions of key terminology, security issues, data transfer issues, audit trails and supporting procedural infrastructure.

Learn from leading industry experts and take advantage of this key opportunity to network with industry colleagues. As a delegate at 2002 East Coast Annual Computer and Software Validation: Ensuring System Compliance with 21 CFR 11, you also receive a complete set of program documentation, a valuable reference tool for your office.