Dublin, Aug. 16, 2021 (GLOBE NEWSWIRE) — The “Computer Arrangement Validation Boot Camp” training has been added to ResearchAndMarkets.com’s offering.
A advance advised to absolutely asperse you in computer arrangement validation. This advance delivers apperception of the regulations impacting your systems and hands-on convenance autograph validation documents. You will leave accessible to advance efficient, effective, inspection-ready validation projects.
Boot affected is boxy and challenging. It is a five-day complete captivation in the validation process. Participants will assignment in focused teams to complete hands-on validation activities through instruction, exercises, and case scenarios. The advance moves bound and participants will change apparatus generally to accumulate absorption aerial and board assorted acquirements styles. A antithesis of adviser lectures, account materials, contest and case studies keeps activity levels aerial and challenges the participants.
Our Training Approach
We accept advised a computer arrangement validation advance that not alone meets FDA, ICH, and Eudralex expectations for risk-based validation but additionally prepares you to apparatus these practices in your company. The accepted operating procedures and validation templates acclimated in chic accept already been accurate at added companies. We are focused on your apperception and appliance of the CSV techniques that will aftereffect in efficient, effective, and inspection-ready validation initiatives.
What You Get
Understanding of how the CSV action fits into your Software Life Cycle (SDLC or SALC) and the purpose of anniversary validation deliverable
Hands-on convenance creating key validation deliverables, including Validation Plans, Requirements Specifications, Analysis Plans, Validation Tests (IQ, OQ, PQ), Trace Matrices, Analysis Summaries, and Validation Reports
Best practices for validation analysis execution, documentation, and absurdity handling
Comprehension of what software does and does not crave validation
Methodology and accomplishing archetypal for a risk-based access to CSV
Details on how to advantage risk-based accommodation authoritative in your software affection affirmation procedures
Understanding of the key apparatus and attempt of a software affection affirmation (SQA) affairs and accountant expectations
Understanding of the key FDA and all-embracing regulations and advice apropos CSV and which administer to your company
Current abstracts and 9 years of trends on the best accepted FDA Warnings apropos software validation and arrangement quality
BONUS: Advance allotment includes 23 hrs Adviser Led Training Online, Advance Binder Electronic Copy, CSV Exam & CSV Certification.
Key Topics Covered:
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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 Arrangement Validation (CSV)
Validation, Verification, and Qualification
Common SDLC Methodologies
GAMP 5 “V” Model
Computer Arrangement Validation (CSV) vs. Computer Software Affirmation (CSA)
Waterfall vs. Agile Methodology
DAY 2
Module 3: CSV Planning
Validation Strategy Document (VSD)
Validation Strategy Components
Rationale for Validation Testing
GAMP 5 Arrangement Categorization
Risk Assessment
Risk Mitigation
Exercise: Risk Assessment
Module 4: Arrangement Requirements and Design
Requirements Development
User Requirements Specification (URS)
Functional Requirements Specification (FRS)
System Design/Configuration Management Specification (SDS/CMS)
Exercise: Appliance and Design
Module 5: IQ, OQ, PQ Analysis Planning & Execution
Module 6: Analysis 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 Arrangement 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 Affidavit Practices (GDPs)
Training
Organizational Change Management (OCM)
CSV Policies and Procedures
Module 9: Managing FDA-Regulated Data
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
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 Analysis Protocol Writing
Exercise 6: RTM Writing
Exercise 7: Be the Consultant
Final Exam Prep
Take Home Final Exam
For added advice about this training appointment https://www.researchandmarkets.com/r/gp4fi5
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