3-Day Process & Software Validation

3 Day Schedule: 7:30 AM – 4:30 PM MST   Audience: Beginner to Advanced

Overview

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.

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:

1. 1. 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. 1. 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