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 & 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 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.


  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:
      1. Validation Team
      2. 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