Five-Day Online Computer Systems Validation Professional Certificate Program (September 6-10, 2021) – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–Computer System Validation Boot Camp training has been added to from ResearchAndMarkets.com offer.

A course designed to fully immerse you in the validation of computer systems. This course helps you understand the regulations that impact your systems and practice writing validation documents. You’ll leave ready to conduct validation projects that are efficient, effective, and inspection-ready.

Boot camp is tough and challenging. This is a complete five-day immersion in the validation process. Participants will work in focused teams to perform hands-on validation activities through instruction, exercises, and case scenarios. The course moves quickly and participants will change gears often to maintain high interest and accommodate multiple learning styles. A balance of instructor lectures, reading material, exercises and case studies keeps energy levels high and challenges participants.

Our approach to training

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 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.

What you get

  • Understanding of how the CSV process fits into your software lifecycle (SDLC or SALC) and the purpose of each validation deliverable

  • Hands-on practice of creating key validation deliverables including validation plans, requirements specifications, test plans, validation tests (IQ, OQ, PQ), tracking matrices, test summaries and validation reports

  • Best practices for running validation tests, documentation, and error handling

  • Understanding of what the software does and does not require validation

  • Methodology and implementation model for a risk-based CSV approach

  • Details on how to leverage risk-based decision making in your software quality assurance procedures

  • Understanding of the key components and principles of a software quality assurance (SQA) program and auditor expectations

  • Understanding of key FDA and international CSV regulations and guidelines that apply to your business

  • Current data and 9 years of trends on the most common FDA warnings regarding software validation and system quality

  • BONUS: Course registration includes 23 hours of instructor-led online training, an electronic copy of the course workbook, CSV exam, and CSV certification.

Main topics covered:

DAY 1

Module 1: FDA Compliance

  • Therac 25 Case Study

  • Today’s lessons

  • Impact on CSV regulations

  • FDA predicate rules

  • FDA compliance and enforcement

  • FDA Inspection

  • FDA compliance toolset

  • FDA Form 483

  • FDA warning letter

  • FDASIA

  • Eudralex annexes 11, 20 and III

  • ICH guidelines

  • PIC/S guides

  • Exercise: Exploring the regulations

  • Exercise: Using FDA.gov

  • Quiz: FDA Guidelines

Module 2: CSV Methods and Templates

  • GxP systems

  • Computer System Validation (CSV)

  • Validation, verification and qualification

  • Common SDLC Methodologies

  • GAMP 5 “V” model

  • Computer System Validation (CSV) vs Computer Software Assurance (CSA)

  • Waterfall vs. Agile

DAY 2

Module 3: CSV Planning

  • Validation Strategy Document (VSD)

  • Validation Strategy Components

  • Justification of validation tests

  • Categorization of the GAMP 5 system

  • Risk assessment

  • Risk mitigation

  • Exercise: Risk assessment

Module 4: System Requirements and Design

  • Requirements Development

  • User Requirements Specification (URS)

  • Functional Requirements Specification (FRS)

  • System Design Specification/Configuration Management (SDS/CMS)

  • Exercise: Application and design

Module 5: Planning and Executing IQ, OQ, PQ Tests

  • IQ, OQ, PQ Purpose and content

  • Running CSV tests

  • CSV test summary report

Module 6: Testing and Validation Reports

  • Purpose and Content of the Requirements Traceability Matrix (RTM)

  • Purpose and Content of the Validation Summary Report (VSR)

  • Notification of acceptance and publication of the system

DAY 3

Module 7: CSV Operations and Maintenance

  • Maintain a system in a validated state

  • Disaster recovery planning

  • Business Continuity Planning

  • Records retention

  • System retirement challenges

  • Legacy systems and integration

  • Data migration

Module 8: CSV Support Components

  • Good Documentation Practices (GDP)

  • Training

  • Organizational Change Management (OCM)

  • CSV policies and procedures

Module 9: Managing FDA Regulated Data

  • 21 CFR Part 11 Guidelines

  • Requirements for Electronic Records/Signatures (ER/ES)

  • Data lifecycle approach

  • Data integrity

  • Data governance

DAY 4

Module 10: Software and Services

  • Off-the-Shelf (COTS) Computer Software

  • FDA “Case for Quality”

  • Cloud systems

  • Software as a Service (SaaS)

  • Platform as a Service (PaaS) and Infrastructure as a Service (IaaS)

  • Single sign-on (SSO)

  • Medical Devices and Software as a Medical Device (SaaMD)

  • Mobile devices and medical application

  • Spreadsheet Validation

Module 11: Supplier Audit

  • Preparation for audits

  • Execution of audits

  • Post-audit

Module 12: FDA Trends

  • Regulatory influences

  • Regulatory trends

  • Critical mind

  • Current trends in compliance and enforcement

DAY 5

Module 13: Preparation for the inspection

  • Preparation for FDA inspections

  • Industry Best Practices

Module 14: CSV Exercises

  • Exercise 1: CSV

  • Exercise 2: Writing the Validation Master Plan (VMP)

  • Exercise 3: FDA Requirements for ER/ES

  • Exercise 4: Interviews and writing URS/FRS

  • Exercise 5: Writing an IQ, OQ, PQ test protocol

  • Exercise 6: Writing RTM

  • Exercise 7: Be the consultant

  • Preparation for the final exam

  • Take-home final exam

For more information on this training visit https://www.researchandmarkets.com/r/w2dv5m

Gordon K. Morehouse