Process and Software Validation

Course Description
This three-day Process and Software Validation training course is designed for professionals in the Pharmaceutical, Medical Device, Biotech, Biopharmaceutical and Skin/Cosmetic industries who are responsible for process and/or software validation.

Who Should Attend
This course is appropriate for individuals responsible for planning and operating a compliant validation program, including:

  • 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

Learning Objectives
Through training, participants will learn:

  • Process Validation from a regulatory perspective
  • Process Validation Requirements and the Elements of a Process Validation Master Plan
  • How to implement a Documented Validation System
  • How to design and execute a Validation Protocol
  • The Validation Life Cycle
  • Software Validation

Course Outline

1. Introduction to Process Validation

  • Regulatory Perspective
    • Understand the importance of process validation from a compliance perspective
    • Recognize the role process validation plays in understanding process and product variability
    • Understand the perspectives of the FDA, international regulators and the GHTF
    • Appreciate the consequences of non-compliance, a review of recent Warning Letters and Consent Decrees
  • Process Validation Requirements
    • Requirements of 21 CFR Part 810.75
    • Requirements of ISO 13485:2003 and ISO 14971
    • Recommendations of GHTF N99-10
    • 21 CFR 211, ICH- Guidance
    • Difference between validation, verification, qualification, commissioning
    • Approaches to validation (i.e. prospective, concurrent and retrospective validation)
  • Elements of Process Validation Master Plan
    • Master Validation Plan
    • Site Master Plan
    • Assessing the status of existing systems
    • Identifying the systems to be validated
    • Assigning the priority and importance
    • Defining and controlling the Master Validation Plan (MVP)
    • An audit perspective of the Validation Master Plan

Group Exercise: “Create Validation Master Plan”

2. Process Validation System

  • Implementing a Documented Validation System
    • Documented Validation System
    • Design, Installation, Operation and Performance qualifications
    • Validation protocols and reports
    • Application of risk management to process validation
    • Training and competence
    • Determining when revalidation is required
    • Change Control

Group Exercise: Analysis of a Validation Protocol

Group Exercise: Write a Validation Standard Operating Procedure

3. Designing a Validation Protocol

  • The Process Validation Steps
    • Design Qualification
    • Installation Qualification
    • Operation Qualification
    • Process Qualification
    • Defining the protocol
    • Executing the protocol
    • Documenting the results of the validation
    • Discrepancies during validation
    • Protocol deviations and failures
  • Validation Protocol Design
    • Establishing the objective
    • Defining the critical process parameters
    • Defining tests to perform
    • Defining acceptance criteria
    • Deviation report & Log
    • Use of the protocol as the report
    • Role of measurement and analysis
  • Installation Qualification
    • Manuals
    • Equipment life cycle
    • Preventive maintenance
    • Calibration
    • Utilities
    • Remedial maintenance / moves
    • Requalification

Individual Exercise: Write an IQ Protocol

  • Operation Qualification
    • Operations Manuals
    • Determining functions to test
    • Programming vs. parameter entry
    • Standards
    • Recording observations
    • Difference between OQ and Capability Studies, and purpose of each

Individual Exercise: Write an OQ Protocol

  • Process Qualification / Process Validation
    • Statistical Tools of Process Validation
      • Averages, medians, mode and standard deviation
      • Cpk or process capability
      • Control charting to monitor performance
      • T-tests, ANOVAs and F-tests
      • Design of Experiments
      • Data handling and data analysis
    • Trials
    • Determining Acceptance Criteria
    • Classical Design Space

Individual Exercise: Participants will develop test criteria for a Validation Protocol

4. Executing a Validation Protocol

5. The Validation Life Cycle

  • Re-validation
    • When, why and what
    • Handling problems during re-validation
    • Product and process implications
  • Product complaints and process failures
    • Evaluating process parameters as a cause of product failures
    • Design changes
    • Process change history
    • Role of corrective action and FMEA
    • Amending the existing MVP

6. Software Validation 

  • Software Validation
    • Scope of implementation
    • System control, roles and responsibilities
    • Electronic records and electronic signatures
    • System requirements through to validation
    • Handling and assessing source code
    • Role and importance of the traceability matrix
    • Defining and executing test scripts
    • System validation
    • Software customization and changes/updates

VII. Closing

Course Format
24 hours
Available virtually
8:30am-4:30pm(EST) each day


Payment Type:
Date Attending
Name of Attendee(s)
Name of Company



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