The purpose of this computer system validation course is to fully acquaint you with the concepts, procedures, and recommended practices of computer system validation (CSV). You will obtain practical experience writing validation documents as well as knowledge of the laws that affect your systems. Regardless of whether you opt to use an agile or traditional waterfall methodology, you will leave prepared to lead efficient, effective, inspection-ready validation projects.
Boot camp is difficult and demanding. It is a three-day thorough immersion in the validation process, covering current technological advancements and best practices from the industry. Through lectures, practice exercises, and real-world case studies, participants will complete practical validation activities with computerized system validation training.
Learning Intentions
Knowing how to adhere to important FDA and international CSV laws and guidelines, like 21 CFR Part 11 and Annex 11
The objective of each validation deliverable, including the Validation Plan, Requirements Specification, Test Plan, Validation Tests (IQ, OQ, PQ), Trace Matrix, Test Summary, and Validation Report, as well as practical experience in developing each deliverable
Understanding risk-based validation techniques and how to use them to construct effective yet legal validation methods
Appropriate validation techniques for a wide range of applications, such as cloud/SaaS, COTS, spreadsheets, and specially created systems
Understanding best practices for online computer system validation training courses and software quality assurance (SQA) programs, as well as inspector expectations
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The following individuals will profit
Analysts in information technology
IT professionals who develop and test software
Professionals in software quality assurance
Managers and analysts of QC/QA
Chemical analysts
Managers of Compliance and Audit
Analysts of automation
Managers and Specialists in Manufacturing
Supply Chain Managers and Specialists
Specialists in Regulatory Affairs
Specialists in Regulatory Submissions
Join the seminar for the high-rated FDA process validation training with World Compliance Seminars in North Carolina, USA. For more and the registration process, connect through our website.
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