Computer system validation & maintenance
Computer System Validation & Maintenance based on GAMP 5 (2nd Edition)
Are you ready to deepen your expertise in computerized system validation and maintenance according to the latest GAMP 5 guidelines (2nd Edition)? This course is designed for professionals in the pharmaceutical, biotech, and medical device industries who need to validate, qualify, and maintain computerized systems in compliance with regulatory expectations.
π Enroll now on Udemy and start building your CSV expertise today.
What you will learn
- Comprehensive introduction to Computer System Validation (CSV) and system maintenance following GAMP 5 (2nd Edition).
- Key updates and what's new in GAMP 5 Edition 2.
- Step-by-step guidance to build validation and maintenance procedures: planning, qualifications, and reporting.
- Use of risk management, risk analysis, system life cycle (SLC), and the V-Model in a GxP environment.
- Developing requirement specifications, executing qualification phases, and preparing validation reports.
- Operating and maintaining validated computerized systems to ensure ongoing compliance and reliability.
Who should join
- CSV Specialists, QA Professionals, and IT experts working in regulated industries.
- Software Testers and Developers in GxP environments.
- Consultants, auditors, and compliance professionals supporting CSV processes.
Why take this course?
- Regulatory relevance: Stay compliant with globally recognized GAMP 5 Edition 2 guidelines.
- Practical knowledge: Gain tools and templates you can use immediately in your work.
- Career growth: Enhance your role in quality assurance, compliance, and IT within GxP industries.
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