Computer System Validation Boot Camp: 5 full days

The “Computer System Validation Boot Camp” seminar has been added to the offer.

RALEIGH, NC, July 13, 2021 (GLOBE NEWSWIRE) – World Compliance Seminars (WCS), a leader in training and consulting, announced a live online boot camp on the validation of IT systems from the 23 as of August 27, 2021. This peer recommended interactive The workshop is still selected by professionals from global organizations in health, pharmacy, biotechnology and medical devices.

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

This training will begin with an officinal treatment of CSV fundamentals. After laying the groundwork, it will move to a format to include interactive lectures and many exercises on the validation plan, the requirements of the traceability matrix, and the completion of the validation summary report.

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

Each participant will be able to understand the rationale for the CSV process and, overall, understand “How the FDA thinks” when auditing the firm’s CSV documentation.

Time 10:30 am – 5:30 pm EDT | 7:30 a.m. – 2:30 p.m. PDT (3 p.m. plus a seminar led by a virtual instructor)

Highlights of the agenda
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) vs Computer Software Assurance (CSA)

Module 3: CSV Planning (Validation strategy document; rationale for validation testing; categorization of the GAMP 5 system; risk mitigation)

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

Module 5: Planning and Execution of IQ, QO, PQ Tests (IQ, OQ, PQ Objective and content; Running the CSV test)

Module 6: Test and validation reports (Objective and content of the requirements traceability matrix (RTM); Objective and content of the validation summary report (VSR))

Module 7: CSV Operations and Maintenance (Disaster recovery planning; Record keeping; Legacy systems and integration; Data migration)

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

Module 9: Managing FDA Regulated Data (Guide 21 CFR Part 11; 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 (Preparing the audit; Performing the audit; Post-audit)

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

Module 13: Preparation for the inspection (FDA Inspection Preparation; Industry Best Practices)

Module 14: CSV exercises (Writing of the Validation Master Plan (VMP); Writing of interviews and URS / FRS; Writing of IQ, OQ, PQ test protocol; RTM writing)

This training camp designed by World Compliance Seminars (WCS) is a balance of lecture, reading material, exercises and case studies that will keep your energy level high, it will challenge you every time. stage of your learning 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 sales and professional managers who must:

  • Manage or participate in IT systems 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 IT system validation process
  • Write, implement or upgrade CSV policies and procedures that use a risk-based approach to meet the latest regulatory expectations
  • Understand the FDA and international regulatory landscape around CSV

The registration cost includes:

  • Document checklist and instructions on how to create
  • Course workbook
  • Numerous 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 suit your team. Private lessons start at $ 12,500 for up to twelve (12) students – that’s 70% off the full price. Contact us for pricing for larger groups, additional questions or to schedule your session.

We help you find the right course for you. WCS Consulting Inc. has the best experts and consultants in the industry 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 superior quality training that will meet your training objectives. For more information, visit Contact us for your Life Sciences Regulatory Compliance Training. Reservation toll free at 844-267-7299 or by e-mail at [email protected] This course is part of a library of certified courses that are delivered in innovative ways to support the learning, engagement, measurement and success of professionals on the go.

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


David Jones, Senior Press Director

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Gordon K. Morehouse