3-Day Process & Software Validation


3 Day Schedule: 7:30 AM – 4:30 PM MST


Audience: Beginner to Advanced
Process and Software Validation Training RTP Certified by Exemplar Global


Our process and software validation training course is ideal for professionals in the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical and Skin/Cosmetic industries who are tasked with process and/or software validation.

Who Should Attend?

  • Those responsible for planning and operating a compliant process and software validation program.
  • Key players such as Process Engineers, Operations, Quality, and Regulatory personnel.
  • R&D, Design Engineers, and Product Formulators who translate product requirements into manufacturing requirements.

Process and Software Validation Training Agenda

  1. Introduction to Process Validation
  • Regulatory Perspective
    • Understand the key concepts of Process/Software validation in the Life Cycle of the medical device
    • Recognize the role process/software validation play in the safety and effectiveness of process outputs
    • Study the requirements of a Validation Protocol:(IQ) Installation Qualification, (OQ) Operational Qualification and (PQ) Performance Qualification
    • Understand the perspectives of the FDA, international regulators, and the GHTF
  • Process Validation Requirements
    • Verification vs. Validation decision
    • Regulatory Process/Software Validation guidance documentation
    • Requirements of 21 CFR cGMPs
    • Requirements of ISO 13485 and ISO 14971
    • Recommendations of GHTF SG-3
    • Approaches to validation (i.e. prospective, concurrent, and retrospective validation)
  • Elements of Process Validation Planning
    • Master Validation Plan
    • Statistical Methodology Overview:  Capability Studies Cp and Cpk, Control Charts, Challenge Test, Design of Experiments, FMEA, Poka Yoke, Robust Design
    • Validation Methodology
    • Validation Method:
      • Validation Team
      • Validation Master Plan

Group Exercises: Validation vs. Verification; Process Capability; Validation Master Plan;

  1. Process Validation Methodology cont.
  • Validation Protocol Development
  • Phases: DQ, IQ, OQ, PQ
  • Addressing Deviations
  • Final Report
  • Installation Qualification and Concepts
  • Operational Qualification and Concepts
  • Performance Qualification and Concepts
  • Process Validation Final Report
  • Maintaining State of Validation
  • Evaluating Changes in Validated Processes: Need for Re-validation/Partial Re-validation
  • Validation Case Studies:
    • Prepping for an IQ
    • Review an IQ


Group Exercises: Validation Protocol Template; Review of Validation Protocol Case; Installation Qualification Template; Review Installation Qualification Case; Operational Qualification Template; Operational Qualification Case; Performance Qualification Template; Performance Qualification Case; Prepping for an IQ; Review an IQ



III. Software Validation

  • CDRH:  FDA Software Validation Guide
    • FDA Study of MD Recalls due to Software issues
    • Design Validation of Software
  • Principles of Software Validation
    • SRS:  Software Requirements Specification
    • Defect Prevention
    • Software Life Cycle
    • Software Validation Plan
    • Classic “V” Diagram
      1. Functional Specifications
      2. Design Specifications
      3. IQ Tests
      4. OQ Tests
      5. PQ Tests
      6. Reporting
  • Test Case: Log In Page Software Application
  • Software Validation Procedure
  • Software Validation After Change
  • Independence of Review
  • Flexibility and Responsibility
  • Software Validation Tasks
    • Testing by the Software Developer
    • Validation of Automated Process Equipment and Quality System Software
    • Define User Requirements
    • Validation of COTS software
  • Which software systems need validation?
  • Documentation required for a software validation
    • SRS
    • Software Verification Protocol
    • Software Verification and Validation Report
  • 10-Steps to Software Validation
    • User Requirements
    • Project Plan
    • Functional Specifications
    • GAP Analysis
    • Installation Protocol
    • Installation Report
    • Testing Protocol
    • Testing Report
    • System Release/Go Live
    • Validation Completed

Individual Exercise: In-Class Log In Page; Prepping for an OQ; Review OQ Case; Prepping for PQ; COTS Software Testing; V&V Traceability Matrix