User Requirements Specifications: A Compliance Primer

Date: January 11, 2017
Duration: 90-Minutes
Price: $299 - Includes Bonus Handouts!

Course Description:

User Requirement Specifications (URS) are the foundation of capital projects, remediation projects, and process modifications from tech transfer, through design, qualification, and validation.  The importance of robust, meaningful and quantifiable User Requirements cannot be understated.  Regardless of the application, direct input from the process or product end user is critical to its design, as is the transfer of that input to the final URS document.  Despite this, URS documents are often largely overlooked, and addressed late in the project lifecycle only to satisfy a project stage-gate or quality requirement.   

Join our interactive online training course where you will to learn:

  • Regulatory and compliance basis for URS
  • Development of an overarching User Requirement Brief (URB)
  • Development of meaningful and measurable User Requirement Specifications
  • Common pitfalls in URS development
  • Utilizing URS to “validate” system design and deliverables
  • Utilizing URS as a planning tool for commissioning, qualification, and validation

This course will be of benefit to anyone involved in capital projects within the life sciences/pharmaceutical industries and particularly those involved in conceptual and preliminary design, commissioning, qualification, and validation.  Additionally, this course will benefit those involved in qualification and validation remediation activities and periodic review.

Christina Meyer Dell Cioppia is senior vice president of validation and regulatory compliance with Amec Foster Wheeler (AFW) where she is responsible for CQV projects worldwide.  Before joining AFW in 2003, Christina held various positions with Kvaerner Process for fourteen years as a process engineer, CQV specialist, project manager, director, and ultimately vice president of validation. 

Christina has assisted biopharmaceutical, vaccine, pharmaceutical, and aseptic processing firms worldwide in the areas of commissioning, qualification, validation, design reviews, cGMP audits, program development, project management, training, remediation, and worldwide regulatory compliance. 

Christina holds her BS in biochemical engineering from Rutgers University, and an MBA in industrial management from Fairleigh Dickinson University. She is a frequent industry speaker and contributing author to the ISPE Baseline Commissioning and Qualification Guideline and the Good Design Practices Guideline for Pharmaceutical Manufacturing Facilities.