In this Computerized Systems Validation (CSV) seminar, you will learn how to validate your computer software quickly and in compliance with the requirements of ISO 13485:2016 and 21 CFR part 820.
This one-day seminar on computer systems validation will focus on the following learning objectives:
Time | Topic |
9:00 AM | Start of seminar |
9:00 AM | Expectations |
9:15 AM | Introduction, definition of terms (incl. IQ, OQ, PQ), examples of systems, overview of process |
10:00 AM | Regulatory requirements for CSV |
10:30 AM | Break |
10:45 AM | Determine intended purpose, process and software requirements |
11:15 AM | Analyze risks, classify systems, determine scope of validation |
12:00 PM | Summary, recap, Q&A |
12:15 PM | Lunch |
1:15 PM | Selecting test methods and tools |
2:00 PM | Creating a validation plan and test specification |
2:45 PM | Break |
3:00 PM | Performing and documenting validation, Good Documentation Practice (GDP) |
3:30 PM | Changing systems, deciding on re-validation |
3:45 PM | Roles and responsibilities, procedural instructions for CSV |
4:15 PM | Overview of best practice guides e.g., AAMI TIR 36, IEC 80002-2, GAMP |
5:00 PM | Summary, recap, Q&A session |
5:15 PM | End of seminar |
This seminar on Computerized System Validation is aimed at the following groups in particular: