Computer Systems Validation Boot Camp: A complete 5-day immersion in the validation process (August 23-27, 2021)

The “Computer System Validation Boot Camp” seminar has been added to the worldcomplianceseminars.com offering.

RALEIGH, North Carolina, July 13. 2021 (GLOBE NEWSWIRE) — World Compliance Seminars (WCS), a leader in training and consulting, has announced a live IT systems validation boot camp from August 23-27, 2021. This peer recommended is always selected by professionals from global health, pharmaceutical, biotechnology and medical device organizations.

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Our training approach is such that we have designed a computer system validation course that not only meets FDA, ICH and Eudralex expectations for risk-based validation, but also prepares you to put implement these practices in your business. The standard operating procedures and validation models used in the classroom have already proven themselves in other companies. We focus on your understanding and application of CSV techniques that will result in effective, efficient and inspection-ready validation initiatives.

This training will begin with a pharmacy treatment of the fundamentals of CSV. After laying the groundwork, it will transition to a format that includes interactive lectures and plenty of exercises on the validation plan, traceability matrix requirements, and writing a validation summary report.

All participants must appear for the final exam and will also be rewarded with CSV certification.

Each participant will be able to understand the logic of the CSV process and overall understand “how the FDA thinks” when auditing company CSV documentation.

Time 10:30 a.m. – 5:30 p.m. EDT | 07:30 – 14:30 PDT (15 hours plus virtual instructor-led seminar)

Agenda Highlights
Module 1: FDA Compliance (CSV Regulations; Compliance Toolkit; Form 483; ICH/PICS Guidelines; Eudralex Annex 11, 20 and III)

Module 2: CSV Methods and Templates (GxP systems; GAMP 5 “V” model; Computer System Validation (CSV) against Computer Software Assurance (CSA)

Module 3: CSV Planning (Validation Strategy Document; Validation Testing Rationale; GAMP 5 System Categorization; Risk Mitigation)

Module 4: System Requirements and Design (URS; FRS; System Design/Configuration Management Specification (SDS/CMS)

Module 5: Planning and Executing IQ, OQ, PQ Tests (IQ, OQ, PQ Purpose and content; CSV test run)

Module 6: Testing and Validation Reports (Purpose and content of Requirements Traceability Matrix (RTM); Purpose and content of Validation Summary Report (VSR))

Module 7: CSV Operations and Maintenance (Disaster recovery planning; records retention; legacy systems and integration; data migration)

Module 8: CSV Support Components (Good Documentation Practices (GDP); CSV Policies and Procedures)

Module 9: Managing FDA Regulated Data (21 CFR Part 11 Guidelines; Data Lifecycle Approach; Data Integrity; Data Governance)

Module 10: Software and Services (COTS Software; Cloud Systems; Software as a Service (SaaS); Platform as a Service (PaaS) and Infrastructure as a Service (IaaS); Single Sign On (SSO); Spreadsheet Validation)

Module 11: Supplier Audit (Audit preparation; Audit execution; Post-audit)

Module 12: FDA Trends (Current trends in compliance and enforcement)

Module 13: Preparation for the inspection (FDA inspection readiness; industry best practices)

Module 14: CSV Exercises (Drafting of the validation master plan (VMP); Drafting of interviews and the URS/FRS; Drafting of the IQ, OQ, PQ test protocol; Drafting of the RTM)

This boot camp designed by World Compliance Seminars (WCS) is a balance of instructor talks, reading material, exercises and case studies that will keep your energy levels high, it will challenge you at every step as you learn with us throughout this course. What you cannot avoid, you must overcome.

Who Should Take the Computer System Validation (CSV) Online Training Course
IT, QA and business managers and professionals who need to:

  • Manage or participate in IT system projects requiring validation

  • Create or approve CSV project deliverables, such as requirements documents, validation protocols (IQ, OQ, PQ), test plans, and test reports.

  • Understand the computer system validation process

  • Create, implement or upgrade CSV policies and procedures that use a risk-based approach to meet the latest regulatory expectations

  • Understand the FDA and the international regulatory landscape around CSV

The registration cost includes:

  • Document checklist and creation instructions

  • Course binder

  • Many exercises on the validation plan, the requirements traceability matrix and the validation summary report.

  • Training certificate

Please bring a laptop to training camp. You will need internet access, spreadsheet and word processing applications, and a PDF reader.

Private session: We can bring you this course. Save on travel costs and select dates that work for your team. Private lessons start at $12,500 for up to twelve (12) students – that’s 70% off full price. Contact us for larger group rates, additional questions or to schedule your session.

We help you find the right course for you. WCS Consulting Inc. has the best industry experts and consultants in the country. Our on-site trainers and consultants provide you with the most useful and up-to-date information available at the most reasonable price. Our trainers and consultants will exceed your expectations by providing you with top quality training that will meet your training objectives. For more information, go to https://worldcomplianceseminars.com Contact us for your life sciences regulatory compliance training. Book toll-free at 844-267-7299 or email us at [email protected] This course is part of a library of certified courses delivered in innovative ways to support the learning, engagement, measurement and success of on-the-go professionals.

For more information or to register online for this CSV training course, visit online

https://worldcomplianceseminars.com/p/computer-system-validation-boot-camp-virtual-seminar

contacts
Worldcomplianceseminars.com

David Jones, Senior Press Director

[email protected]

For EST business hours, call 1-347-282-5400

For US/CAN call toll free 1-844-267-7299

Gordon K. Morehouse