This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.
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:
The following disciplines will directly benefit from this webinar:
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:
- 21CFR Part 11
- 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
Course Provider
Gaurav Walia,
