User Requirements Specifications: A Compliance Primer

Teachers
Christina Meyer Dell Cioppia
Category:
Introductory Pharma Courses/ Manufacturing (GMP)/ On-Demand Courses/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90 minutes
On-demand
Includes handouts

Description

COURSE DESCRIPTION

OVERVIEW

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.

LEARNING OBJECTIVES

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

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

Who Should Attend

WHO SHOULD ATTEND

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 reviews.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 (9am – 5pm EST, M-F) for assistance.

About Instructors

Christina Meyer Dell Cioppia
Has assisted biopharma, vaccine, pharma, and aseptic processing firms worldwide in commissioning, qualification, validation, design reviews, cGMP audits, and worldwide regulatory compliance.

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