DUBLIN–(BUSINESS WIRE)–The “Computer System Validation Boot Camp” training has been added to ResearchAndMarkets.com’s offering.

Computer System Validation Professional Certificate Program

A course designed to completely immerse you in computer system validation. This course delivers comprehension of the regulations impacting your systems and hands-on practice writing validation documents. You will leave ready to lead efficient, effective, inspection-ready validation projects.

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

Our Training Approach

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.

What You Get

Understanding of how the CSV process fits into your Software Life Cycle (SDLC or SALC) and the purpose of each validation deliverable

Hands-on practice creating key validation deliverables, including Validation Plans, Requirements Specifications, Test Plans, Validation Tests (IQ, OQ, PQ), Trace Matrices, Test Summaries, and Validation Reports

Best practices for validation test execution, documentation, and error handling

Comprehension of what software does and does not require validation

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

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 the key FDA and international regulations and guidance regarding CSV and which apply to your company

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

BONUS: Course registration includes 23 hrs Instructor Led Training Online, Course Binder Electronic Copy, CSV Exam & CSV Certification.

Key Topics Covered:

DAY 1

Module 1: FDA Compliance

Therac 25 Case Study

Lessons for today

Impact on CSV regulations

FDA Predicate Rules

FDA Compliance and Enforcement

FDA Inspection

FDA Compliance Toolset

FDA Form 483

FDA Warning Letter

FDASIA

Eudralex Annex 11, 20, and III

ICH Guidelines

PIC/S Guides

Exercise: Exploring the regulations

Exercise: Using FDA.gov

Quiz: FDA Guidance

Module 2: CSV Methods and Models

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 Methodology

DAY 2

Module 3: CSV Planning

Validation Strategy Document (VSD)

Validation Strategy Components

Rationale for Validation Testing

GAMP 5 System Categorization

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/Configuration Management Specification (SDS/CMS)

Exercise: Application and Design

Module 5: IQ, OQ, PQ Test Planning & Execution

IQ, OQ, PQ Purpose and Contents

CSV Test Execution

CSV Test Summary Report

Module 6: Test and Validation Reports

Requirements Traceability Matrix (RTM) Purpose and Contents

Validation Summary Report (VSR) Purpose and Contents

System Acceptance and Release Notification

DAY 3

Module 7: CSV Operations and Maintenance

Maintaining a System in a Validated State

Disaster Recovery Planning

Business Continuity Planning

Record Retention

System Retirement Challenges

Legacy Systems and Integration

Data Migration

Module 8: CSV Supporting Components

Good Documentation Practices (GDPs)

Training

Organizational Change Management (OCM)

CSV Policies and Procedures

Module 9: Managing FDA-Regulated Data

21 CFR Part 11 Guidance

Electronic Records/Signatures (ER/ES) Requirements

Data Life Cycle Approach

Data Integrity

Data Governance

DAY 4

Module 10: Software and Services

Computer Off-the-Shelf (COTS) Software

FDA’s “Case for Quality”

Cloud Systems

Software as a Service (SaaS)

Platform as a Service (PaaS) & 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: Vendor Audit

Audit Preparation

Audit Execution

Post-Audit

Module 12: FDA Trends

Regulatory Influences

Regulatory Trends

Critical Thinking

Current Compliance and Enforcement Trends

DAY 5

Module 13: Inspection Preparation

FDA Inspection Readiness

Industry Best Practices

Module 14: CSV Exercises

Exercise 1: CSV

Exercise 2: Validation Master Plan (VMP) Writing

Exercise 3: FDA Requirements for ER/ES

Exercise 4: Interviews and URS/FRS Writing

Exercise 5: IQ, OQ, PQ Test Protocol Writing

Exercise 6: RTM Writing

Exercise 7: Be the Consultant

Final Exam Prep

Take Home Final Exam

For more information about this training visit https://www.researchandmarkets.com/r/ilp9b2