Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

Why Should You Attend:

In the recent past there has been an explosion of regulatory enforcement specifically involving Computer Systems Validation (CSV), thus this webinar will demonstrate how to proper design/create, test and execute User Requirement Specifications (URS).

This webinar will also focus on key quality systems that are being highlighted in many of the FDA regulatory inspections, such as Computer Systems Validation (focusing on 21CFR Part 11, Electronic Records and Signatures (ERES), Software Development Lifecycle (SDLC), 21CFR Part 11, Audit Trails, etc.)

In essence, the program will cover:

• CSV (Computer Systems Validation)
• URS (User Requirements Specification)
• SDLC (Software Development Lifecycle)
• 21CFR Part 11
• ERES (Electronic Record Electronic Signatures)
• Audit Trail

Areas Covered in the Webinar:

• How to properly create User Requirements Specifications (URS) for Computer Systems Validation (CSV).
• Planning and Requirements: Define compliance requirements, create a validation plan and define user requirements.
• From designing to deployment: Design and build requirements, perform development testing and deploy the system to satisfy all user requirements.
• What are the industry issues?
• What are the difficulties that people are experiencing in this initial phase?
• How hard can it be to create a document detailing? What do you want a system, software or for example a piece of HPLC or mass spec equipment to do?
• What should the URS contain?
• Full life cycle function testing.
• Computer Systems Validation focus:
1. 21CFR Part 11
2. ERES (Electronic Records and Electronic Signatures)
• Current domestic Food and Drug Administration regulatory and inspectional trends.
• Overall current global regulatory enforcement activity.

Who Will Benefit:

This course is designed for people tasked with developing, designing and creating User Requirements Specifications (URS) in Computer Systems Validation (CSV) in the pharmaceutical, biotech and medical device industries. This includes individuals that have quality management systems, validation, qualification and overall compliance/regulatory responsibilities within their organization.

The following disciplines will directly benefit from this webinar:

• Quality Assurance
• Quality Control
• Regulatory Compliance
• Validation/Qualification
• Information Technology (IT)
• Laboratory Information Management Systems (LIMS)
• Research and Development(R&D)
• Scientists
• Managers
• Project Leaders
• Directors
• Computer Systems Validation (CSV) Personnel
• Validation/Qualification Engineers
• All levels of staff throughout an organization from entry level staff to company executives

Instructor Profile:

Gaurav Walia, M.S., is a pharmaceutical consultant – consent decree/computer systems validation. He has most recently worked on three major consent decree projects with McNeil/Johnson & Johnson (CSV), Novartis (third party manufacturing assessment), and b. Braun (CSV, overall QA and compliance, audits). Overall, Mr. Walia has over 19+ years of pharmaceutical experience with careers at Monsanto/Searle, Pfizer/Oread, Forest Laboratories, etc., while also serving as a pharmaceutical consultant in various disciplines from quality systems, consent decree, computer systems validation, etc.

His career is filled with a multitude of experience since his days as an analytical R&D chemist to assistant director of pharmaceutical operations to director of quality assurance and compliance. Mr. Walia has managed various technical, quality and compliance groups, such as but not limited to, pharmaceutical research and development, laboratory information management systems (LIMS), metrology, quality control (QC), computer systems validation (CSV), materials import and export, safety, new facility design, validation and commissioning, quality assurance and compliance, capital budget (instrument and equipment acquisition from R&D to commercial, operating budget (all service contract including vendor certifications and agreements), regulatory compliance, etc.

Concurrently, Mr. Walia’s diverse multi-disciplined background has yielded years of success towards internal audit excellence, successful remediation projects, as well as over 100+ regulatory audits both domestic (FDA) and international (sFDA/Chinese FDA, EMEA, IMB, etc.) which in total were successful inspectional audits.

Overall, Mr. Walia’s career has not only spanned across the globe but has also traveled across many different key pharmaceutical disciplines as well as products such as liquids, solids, patches, crèmes, antibiotics/aseptic processes, medical device, biologics, etc. while also covering nutritional, OTC, generic and proprietary/branded products.

Follow us :