Dublin, Nov. 13, 2023 (GLOBE NEWSWIRE) -- The "CSV Boot Camp - 3-Day Certification Course" has been added to ResearchAndMarkets.com's offering.
The course is designed to provide comprehensive training in computer system validation (CSV) for professionals working in FDA-regulated industries, including pharmaceuticals, medical devices, biotechnology, and more. The course covers a wide range of topics related to CSV, including FDA regulations, system development life cycle (SDLC) methodologies, risk-based validation approaches, electronic records and signatures (ER/ES), and data integrity.
The course is structured as a 3-day training program and includes various components to enhance participants' understanding and practical application of CSV concepts:
-
Course Material: Participants receive course materials that cover key topics and provide reference materials for future use.
-
Exercises: Practical exercises are included in the course content to help participants gain hands-on experience and apply CSV concepts in real-world scenarios.
-
Final Examination and Evaluation: A final exam is provided to assess participants' knowledge and understanding of the course material. Questions and answers for the exam are included.
-
Training Certification: Participants who successfully complete the course and pass the final examination receive a training certification.
-
Hands-On Training: The course is designed to immerse participants in CSV concepts and practical approaches, ensuring they are well-prepared to lead efficient and effective validation projects.
-
Requirements: Participants are required to bring their own laptops with internet access, spreadsheet and word processing applications, and a PDF reader to fully engage in the boot camp.
Course Highlights:
The course covers a wide range of topics essential for CSV professionals, including:
-
Understanding FDA compliance and guidance, as well as other relevant regulations and guidance from organizations like EMA, EU, and MHRA.
-
Exploring CSV methods and models, including GxP systems, validation, verification, and qualification.
-
Addressing software and services related to CSV, such as computer off-the-shelf (COTS) software, cloud systems, and software quality assurance (SQA) plans.
-
Compliance with 21 CFR Part 11 and FDA's guidance for electronic records and signatures (ER/ES).
-
Data integrity and governance, including the data life cycle approach.
-
Planning for CSV, including the development of a validation strategy document (VSD) and risk-based approaches.
-
Creation of validation deliverables, including requirements specifications, test plans, and test reports.
-
Change management, system retirement, and regulatory influences on CSV.
-
Best practices and industry trends in CSV, with a focus on data integrity and risk assessment.