Chester County Economic Development Council - Calendar of Events
21
June 2007, Thursday		 View PreviousReturn to Home PageView Next

Complying with Computer and Software Validation Requirements

The BioScience Partnership is happy to offer the following training sessions for our partners and their employees. Due to a grant from the PA Department of Labor and Industry, the workshops are free to the BioScience Partnership.

Presented by: PTi international
Location: Bio-Imaging Technologies, Inc. in Newtown
Date: June 21-22, 2007 - 8:00am to 5:00pm

Validation of computerized systems is required by FDA. This informative, intimate course clarifies the regulatory requirements and expectations for computer and software validation. The course examines a variety of critical issues, including how to apply proven validation tools and techniques; effective testing and validation strategies; how to conduct a gap assessment; how to create a master validation plan; off-the-shelf software and a lot more. Through discussions and interactions with an accomplished, dynamic instructor as well as your colleagues and peers, this two-day course will empower you to develop and execute a robust approach to computer and software validation.

This course will improve your ability to:

  • Determine what needs to be validated and how much validation is enough to ensure regulatory requirements are met
  • Address FDA expectations for legacy systems and off-the-shelf software and avoid costly regulatory consequences
  • Create and execute a master validation plan to define the performance requirements of your system
  • Generate and maintain adequate IQ/OQ/PQ documentation

Please click here for more details.

Registration Details
Registration form for all workshops can be found here.  The workshops are limited to 20 participants.  The small class size ensures that all attendees are given the opportunity to address issues that matter to them most.

Please register your employees by sending the registration form via email to Marianna Allen at Life Science Career Alliance - mallen@lscalliance.org.  Please register as soon as possible to secure your spot.  Due to limited participation, registrations will be accepted on a first come basis.

Training is funded through a grant from the Pennsylvania Department of Labor and Industry.

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