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.
Who Should Attend:
This training is valuable for professionals working in FDA-regulated industries, including but not limited to:
- IT Managers and Professionals
- QA/QC Managers and Analysts
- Analytical Chemists
- Compliance and Audit Managers
- Laboratory Managers
- Automation Analysts
- Manufacturing Specialists and Managers
- Supply Chain Specialists and Managers
- Regulatory Affairs Specialists
- Clinical Data Analysts and Managers
- Clinical Trial Sponsors
- Computer System Validation Specialists
- GMP Training Specialists
- Business Stakeholders/Subject Matter Experts
- Business System/Application Testers
About the Speaker:
The course is led by Carolyn Troiano, an expert with over 30 years of experience in computer system validation in FDA-regulated industries. Carolyn has worked directly or as a consultant for major pharmaceutical companies and has played a significant role in the development of CSV programs and strategies. She is well-versed in FDA regulations, including 21 CFR Part 11, and has extensive experience in compliance and validation.
Conclusion:
The "CSV Boot Camp - 3-Day Certification Course" offers a comprehensive and practical training opportunity for professionals involved in computer system validation within FDA-regulated industries. Participants will gain valuable insights, hands-on experience, and a certification upon successful completion, preparing them to effectively manage and lead validation projects and comply with regulatory requirements.
For those seeking to enhance their understanding of CSV, this course provides the necessary tools and knowledge to excel in this critical area of regulatory compliance.
For more information about this training visit https://www.researchandmarkets.com/r/sbjomg
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