Computerised System Validation (CSV)

🎓 Course Title: Computerised System Validation (CSV)

🎯 Course Headline: Master the Practical Approach to Achieving Validation Requirements with Expert Insights!

🚀 Course Description:

Dive into the world of pharmaceutical regulatory compliance with our updated Computerised System Validation (CSV) course, featuring the latest updates on 21 CFR Part 11 and the electronic version of CFR part 11. This comprehensive course is designed for those eager to grasp the foundational principles of validation requirements in the pharmaceutical industry, as well as international best practices.

• Regulatory Framework - Understand how regulatory guidance forms a robust and effective framework for creating computerized systems that are fit for their intended use and comply with current regulations.
• Compliance Principles - Gain an overview of the general principles and requirements for compliance in computer systems as per Good Automated Manufacturing Practice (GAMP 5) guidelines.
• Validation Strategies - Explore different validation strategies, including a detailed discussion on black box testing, to ensure that your validation process is thorough and efficient.
• Developing Validation Documents - Learn the step-by-step process of creating essential validation documents such as User Requirements Specification (URS), Functional Requirements Specification (FRS), Failure Mode and Effects Analysis (FMEA), Automated Test Scripts (ATS), System Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Validation Master Plan & Report - Understand the significance of a Validation Master Plan (VMP) and a Validation Master Report (VMR) in validating processes.
• Real-world Applications - Engage with practical case studies and learn from real-life examples to apply your knowledge effectively.
• Common Questions & Expert Answers - Get answers to the most frequently asked questions by industry experts, enhancing your understanding of complex concepts.

🎓 Who Should Attend?

This course is tailored for a wide range of professionals:

• Regulatory Affairs Managers: Ensure compliance and understand regulatory requirements in a pharmaceutical environment.
• Clinical Researchers: Validate clinical data management systems and ensure the integrity of research data.
• IT Professionals in Healthcare, Biopharmaceuticals, and Medical Devices: Secure your IT systems to meet GxP standards and regulatory expectations.
• Software Vendors: Create robust and compliant software solutions for healthcare and pharmaceutical industries.
• Quality Assurance Specialists: Develop a deeper understanding of validation processes and documentation to maintain high-quality standards.
• Auditors & Compliance Officers: Gain the knowledge to conduct effective audits and ensure compliance with regulatory requirements.

📅 Course Structure:

• Week 1: Understanding Regulatory Requirements and Compliance Frameworks
• Week 2: Categorization of Software and Hardware as per GAMP 5, Overview of Validation Strategies
• Week 3: Developing URS, FRS, FAT, SAT, IQ, OQ, and PQ Documents
• Week 4: Implementing Test Strategies, Including Black Box Testing
• Week 5: Crafting Your Validation Master Plan and Validation Master Report
• Week 6: Interactive Session with Q&A on Common Validation Queries

Join us for a transformative learning experience that will elevate your understanding of computerised system validation in the pharmaceutical industry. Enroll now to secure your place in the world of GxP compliance! 📚✅