Understanding CSV User Requirements - Webinar CD/Transcript

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Understanding CSV User Requirements: Save Time and Money by Getting it Right from the Start

For a process supported by a computer system, Computer System Validation (CSV) provides documented proof that the system (hardware, software, peripherals and/or network) will repeatedly and reliably do what it is designed to do, is “fit-for-purpose,” and complies with applicable rules and regulations. Regulators will not take your word for it – there must be formal evidence.

The ultimate goal of any CSV project is to realize and sustain compliance, while ensuring the peak performance and functionality of those systems; it is a sound business practice that supports Q/A and promotes responsible, profitable operations.

The most important element of a CSV

Without a doubt, the User Requirements Specifications (URS) is the most critical document in CSV. User requirements should be the starting point of any project you are working on.  A properly structured and referenced URS will ensure that your user requirements are properly specified, remain traceable and are documented.

All too often companies do not actually spend the required time to develop the user requirements; instead, they rush, and the project suffers as a result. In fact, at least 50% of your time should be spent developing solid user requirements.

Poorly written user requirements can lead to costly delays in validation further down the line, as well as FDA action.

Join Gaurav Walia, a leading CSV expert, as he shows you the most fundamental steps and common pitfalls for writing your URS.   In 90 minutes you’ll learn:

  • The 3 levels of URS and when you need them
    • Installation qualification
    • Operational qualification
    • Functionality qualification
  • How to properly write a URS – one that is clear, concise and testable
  • How to prioritize your URS with emphasis on identifying mandatory requirements
  • What requirements your URS should contain – ones that are specific and appropriate for your desired system
  • Who should be involved in writing a URS
  • How to classify requirements so that appropriate focus is given to the critical ones
  • And much more…

This course will be of benefit:

  • Data Management and Statistical Personnel
  • Engineering and Design Control Teams
  • Executive Management
  • QA/QC Personnel
  • Validation Specialists/Scientist/Engineers

Mr. Gaurav Walia, M.S. has over 17 years of pharmaceutical experience with careers at Monsanto/Searle, Pfizer/Oread, Forest Laboratories, and others while also serving as a pharmaceutical consultant in various disciplines from Quality Systems, R&D, CD, CSV, Vendor Certification, etc. Mr. Walia has managed various technical, quality and compliance groups, such as but not limited to, Pharma R&D, Laboratory Information Management Systems (LIMS), Metrology, Quality Control (QC), Materials Import and Export, Safety, New Facility Design, Validation and Commissioning, Capital Budget (Instrument and Equipment Acquisition from R&D to Commercial, Operating Budget (All Service contracts), Regulatory Compliance, etc. Mr. Walia's diverse, multi-disciplined background has yielded years of success towards internal audit excellence and successful remediation projects. He has well over 100+ regulatory audits with domestic and international regulatory agencies.