The “Computer System Validation Boot Camp” seminar has been added to worldcomplianceseminars.com offering.
RALEIGH, N.C., July 13, 2021 (GLOBE NEWSWIRE) -- World Compliance Seminars (WCS), a leader in providing training and consulting, announced online live boot camp on Computer system validation on August 23-27, 2021. This peer recommended interactive workshop is always selected by professionals at global healthcare, pharmaceutical, biotech 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 implement these practices in your company. The standard operating procedures and validation templates used in class have already been proven at other companies. We are focused on your comprehension and application of the CSV techniques that will result in efficient, effective, and inspection-ready validation initiatives.
This training will kick off with a compendial treatment of CSV fundamentals. After laying the groundwork, it will transition to a format to include interactive lectures and many exercises on validation plan, the requirements of traceability matrix and making of validation summary report.
All the participants are expected to appear for final exam and will also be rewarded CSV certification.
Each participant will be able to understand the rationale within the CSV process and overall, understand “How FDA Thinks” when auditing firm’s CSV documentation.
Time 10:30 AM - 5:30 PM EDT | 07:30 AM - 02:30 PM PDT ( 15 hrs plus Virtual Instructor Led Seminar)
Agenda Highlights
Module 1: FDA Compliance (CSV regulations; compliance toolset; Form 483 ; ICH/ PICS guidelines; Eudralex Annex 11, 20, and III)
Module 2: CSV Methods and Models (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; GAMP 5 System Categorization; Risk Mitigation)
Module 4: System Requirements and Design (URS; FRS; System Design/Configuration Management Specification (SDS/CMS)
Module 5: IQ, OQ, PQ Test Planning & Execution (IQ, OQ, PQ Purpose and Contents; CSV Test Execution)
Module 6: Test and Validation Reports (Requirements Traceability Matrix (RTM) Purpose and Contents; Validation Summary Report (VSR) Purpose and Contents)
Module 7: CSV Operations and Maintenance (Disaster Recovery Planning; Record Retention; Legacy Systems and Integration; Data Migration)
Module 8: CSV Supporting Components (Good Documentation Practices (GDPs); CSV Policies and Procedures)
Module 9: Managing FDA-Regulated Data (21 CFR Part 11 Guidance; Data Life Cycle Approach; Data Integrity; Data Governance)
Module 10: Software and Services (COTS Software; Cloud Systems; Software as a Service (SaaS); Platform as a Service (PaaS) & Infrastructure as a Service (IaaS); Single Sign On (SSO); Spreadsheet Validation)
Module 11: Vendor Audit (Audit Preparation; Audit Execution; Post-Audit)
Module 12: FDA Trends (Current Compliance and Enforcement Trends)
Module 13: Inspection Preparation (FDA Inspection Readiness; Industry Best Practices)
Module 14: CSV Exercises (Validation Master Plan (VMP) Writing; Interviews and URS/FRS Writing; IQ, OQ, PQ Test Protocol Writing; RTM Writing)
This boot camp designed by World Compliance Seminars (WCS) is a balance of instructor lecture, reading materials, exercises and case studies which will keep your energy level high, it will challenge you in every step as you learn with us throughout this course. What you can’t avoid, you must overcome.
Who Should take Computer System Validation ( CSV) Training Course Online
IT, QA, & Business Managers and Professionals who need to:
- Manage or participate on computer 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 process of computer system validation
- Author, implement, or upgrade CSV policies and procedures that utilize a risk-based approach to meeting the latest regulatory expectations
- Understand the FDA and international regulatory landscape around CSV
Registration Cost Includes:
- Checklist of documents and the direction for how to create
- Course binder
- Many exercises on Validation Plan, the Requirements Traceability Matrix, and the Validation Summary Report.
- Training Certificate
Please bring a laptop to boot camp. You will need internet access, spreadsheet and word processing applications and a PDF reader.
Private Session: We can bring this course to you. Save travel costs and select the dates that work for your team. Private classes start at $12,500 for up to twelve (12) students – that’s 70% off full price. Contact Us for larger group pricing, additional questions, or to schedule your session.
We are helping to find the right course for you. WCS Consulting Inc. has the top industry experts and consultants in the country. Our onsite 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 top quality training that will meet your training objectives. For more information, visit https://worldcomplianceseminars.com Contact us for your Life science regulatory compliance training. Booking Toll Free 844-267-7299 or email us support@worldcomplianceseminars.com .This course is among a library of certified courses that is delivered in an innovative way to support learning, engagement, measurement, and achievement for professionals on the go.
For more information or Register Online about this CSV training course online visit
https://worldcomplianceseminars.com/p/computer-system-validation-boot-camp-virtual-seminar
Contacts
Worldcomplianceseminars.com
David Jones, Senior Press Manager
support@worldcomplianceseminars.com
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