2013 Indianapolis Training, May 2014


Practical Implementation of Process Validation Lifecycle Approach (T46)

Level: Intermediate
ISPE CEUs: 2.0
Type: Classroom Training Course

Date Location Country Instructor(s)
This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.


This course is relevant to individuals involved throughout the product lifecycle in validation of products and processes. It will help you link the science and risk-based process validation lifecycle approach to the Pharmaceutical Quality System. It will provide you with practical application of quality risk management in preparation for and planning for validation of manufacturing control strategy. Additional content will focus on technical approaches and pharmaceutical quality management processes supported by quality risk management applied to process design, qualification of equipment, and process performance.

With the implementation of ICH Q8, Q9, Q10 and Q11 guidelines, the draft ICH Q12, the US FDA Process Validation guidance, EMA’s Process Validation guideline and Annex 15, there is now a greater need to understand that process validation should be considered a science- and risk-based, life cycle activity rather than a one-time event of manufacture of three commercial scale batches. Companies should demonstrate that processes in the commercial phase of the lifecycle are maintained in a state of control using a science- and risk-based approach. A pharmaceutical quality system as discussed in ICH Q10 facilitates managing the product lifecycle and facilitates innovation and continual improvement using a change management system to support improvements in business efficiency.

Course content focuses on practical application of the lifecycle approach to PV. Application of Quality by Design principles (QbD) help with the Process Design phase of new products, drug substance processes, and legacy products and may yield significant business benefits by reducing operating costs and enabling more efficient manufacturing processes. This will be explained and exemplified. The Ongoing/Continued Process Verification stage can be considered a continuum from the end of process qualification stage until product discontinuation, i.e. FDA PV Stage 3.

PQLI Part 3 Cover Image

Immediately apply the course learning objectives using the ISPE PQLI® Guide Series: Part 3, Change Management System as a Key Element of a Pharmaceutical Quality System and Part 4, Process Performance and Product Quality Monitoring System. Links to the Guides will be provided prior to the training course.


Mini-regulation handbooks for ICH Q8 (R2), Q9, Q10 and Q11 will be provided during the class.

Course Modules

Day 1

  • Regulatory Climate and Surrounding Changes in Process Validation
    • Breakout Scenario - Review of Warning Letters
  • Process Validation Basics US and EU
    • Breakout Scenario - Similarities and differences between US and EU
  • QRM Applied to PV
    • Breakout Scenario - FMEA
  • Developing Understanding of QbD to Develop Robust Control Strategies (PV Stage 1)
    • Breakout Scenario - Case Study
  • Wrap-up

Day 2

  • Equipment and Qualification
    • Breakout Scenario - Critical Aspects
  • Statistics for PV
  • Readiness for Process Performance Qualification (PPQ) / PV
    • Breakout Scenario - Design of PPQ / PV Study and Protocol
  • Acceptance Criteria, Number of Batches, Sampling Plan
    • Breakout Scenario - Acceptance Criteria Sampling Plan
    • Breakout Scenario - Selecting the Number of Batches for PV Stage 2
  • Wrap-up

Day 3

  • Process Validation / PPQ Execution
    • Breakout Scenario - Analyzing Data
  • Continued Process Verification (CPV) / Ongoing Process Verification (OPV)
    • Breakout Scenario - CPV and OPV Planning
  • CPV / OPV for Existing Products
    • Breakout Scenario - Comprehensive Case Study
  • Wrap-up

Take Back to Your Job

Throughout the process validation lifecycle:

  • Understand the importance of product and process understanding and patient requirements.
  • Know how to apply QRM tools for PV.
  • Recognize opportunities to leverage process design information to establish a process validation strategy and a process performance and product quality monitoring program.
  • Understand the challenges to the application of an entirely science- and risk-based approach.
  • Understand a variety of approaches to applying specific expectations of the lifecycle approach to PV including number of sampling, acceptance criteria and determining the number of batches for PPQ/PV.
  • Understand the differences in expectations among various major world markets.
  • Learn various approaches for deciding which attributes and parameters should be evaluated at a heightened level during PV stage 3.
  • Understand new expectations for routine process monitoring.
  • Understand the process validation lifecycle and the importance of maintaining an effective pharmaceutical quality system.
  • Apply process performance and product quality monitoring system elements to identify opportunities for continual improvement.
  • Minimize chance of validation failures by learning about adequate preparation in process understanding and ancillary systems.
  • Acquire tools to prepare for a smooth validation execution.
  • Understand implications of validation deviations.
  • Maximize and be able to apply your understanding of ICH terminology including the principles of a science- and risk-based approach to the process validation lifecycle.
  • Recognize the value of the requirements of management’s responsibilities within the PQS.

Note: This course will not cover formulation development, the regulatory submission processes or detailed engineering designs and associated qualification.

Who Should Attend

This course is relevant to individuals involved in process validation of products and processes in all sectors of the pharmaceutical industry – small and large molecules, innovators, generics, and lifecycle management.

Specific job functions include:

Development, manufacturing, engineering, quality, and validation professionals with intermediate level experience in development, manufacturing, engineering, validation, quality, technology transfer and those wishing to understand the concept of process validation as a lifecycle.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Active Pharmaceutical Ingredients, Commissioning and Qualification, Critical Utilities, Oral Solid Dosage, Process Analytical Technology, Product and Process Development, Sterile Communities of Practice (COPs).

Continuing Education Units  

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.

Thank you to our Top Tier Sponsors

  • Pinnacle Sponsor
  • Pinnacle Sponsor
  • Pinnacle Sponsor
  • Training Sponsor

Follow ISPE

ISPE Twitter Page ISPE Facebook Page ISPE LinkedIn Page