Computer Systems Validation (CSV) is a process used to ensure that a computer-based systems will produce information or data that meet a set of defined requirements. The process is used within highly regulated environments that directly impact public health and safety such as pharmaceutical and medical device manufacturing. Computer validation is more than a compliance requirement. It not only reduces regulatory risk, but it also increases understanding of system during project implementation and enforces a structured, well-defined execution of the project. Pharmaceutical computer system validation is a unique opportunity for a business to examine their computer systems to maximize effectiveness and enhance quality, with the potential to save cost and time. Subject matter expert (SME) of CSV will have a major role in achieving these benefits. This course will be of benefit to anyone involved in FDA audits and Computer Systems Validation (CSV) on both a domestic and global scale. Additionally, this course will be highly-relevant to those in Quality Assurance, Compliance, Validation, Informatics, Procurement, R&D, Commercial, Quality Control and other job functions which are impacted by CSV efforts. This course is particularly useful to those who interface with vendors, FDA and other regulatory agencies.

Following Modules will be covered during the Basic Certification program with Live project test case scenarios:

Module 1: Quality, Quality Assurance and Quality Control in pharmaceutical and healthcare industries
Module 2: Qualification and Validation
Module 3: Introduction to Computer System Validation
Module 4: Software Development Life Cycle (SDLC)
Module 5: Regulatory requirements for software validation-21 CFR Part 11 (A detailed analysis of USA and EU perspectives )
Module 7: Risk based approach to software quality and Validation
Module 8: GAMP 5 Guidelines & Software Categories
Module 9: Implementation in Life science verticals
Module 10: Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000
Module 11: GDP, GCP, GMP guidelines

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About the Trainer

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9 Students

29 Courses

Dr. Akhilesh Singh

B.Tech, MBA

IT professional with 15+ years of Experience in Computer System Validation/ IT-Regulatory Compliance. Below are the responsibilities and skill set i had the exposure.

End to End Validation planning and Project execution for IT systems in GxP (GCP, GMP, GLP) Area.
Conduct Software system validation activities for core software applications and customized solutions within agreed timelines.
GxP and Risk Assessment
Conduct comprehensive IT systems validation in close cooperation with all involved departments within IT projects: work closely with project team members and IT vendors throughout the entire IT system/ software development life cycle.
Responsible for defining/documenting validation strategy for GxP IT systems. Authoring and reviews of CSV Documents (Validation Plans, Validation Reports, Release Plans, and Release Reports, Requirements, Designs, Test Plans, Test Scripts, Requirements Traceability Matrix, Test Results, and Test Summary Reports).
Reviews and approvals for Change Management and Incident Management
Involved in documentation of Lifecycle development for CSV (IQ, OQ, PQ) and SDLC processes.
21 CFR PART 11, EU Annex. 11
GAMP 5 Guidelines
Deviation/CAPA Management.
Facilitate/conduct and document Periodic Review Reporting/Quality Review meetings.
Conducting Validation and SOP Trainings.
Providing Consultation in CSV Processes to IT Team and Cross Functional Groups.
Support Audits.
Hands on experience in the validation of Instrument softwares-PLCs, SCADA, Sample Analyzers etc.