Risk Based Approach for Pharmaceutical Process Validation & Relevant Documentations

Engineering and Validation

3 days (2 days can be customized)
Course fee

Program Description

Science and Risk-Based Approach to Pharmaceutical Process Validation

  • US-FDA Guidelines for Industry ‐ Process Validation: General Principles and Practices.
  • ISPE Good Practice Guide: Practical Implementation of the Lifecycle Approach to Process Validation.
  • ASTM E2537: Standard Guide for Application of Continuous Process Verification to Pharmaceutical and Biopharmaceutical Manufacturing

Target Level

This course is relevant to all individuals involved in pharmaceutical process and product validation including but limited to:

  • Research and Development Scientists
  • Process Scale-Up, Optimization, and Technology Transfer Engineers
  • Validation and Qualification Engineers and Scientists
  • Quality Compliance and Regulatory Affairs
  • Production Managers and Supervisors
  • Internal / External Auditors and Consultants
  • Regulatory Authorities


They need to understand that process validation should be considered a science- and risk-based, life cycle activity not a one-time event of manufacture of three commercial-scale batches.

  • Manufacturing Process
  • Current Process Validation
  • Process Parameters / Operating Parameters
  • Process Validation – New Guidance
  • Stage 1: Process Design
  • Stage 2: Process Qualification
  • Stage 3: Continued Process Verification (CPV)
    • Applying New Guidance to Old Products
    • Process Sampling
    • Statistics for Validation

Objectives and Expected Results

  • Participants will develop scientific-based knowledge to understand the principles of science- and risk-based approaches to the process validation lifecycle.
  • Participants will focus on the practical application of the science- and risk-based approach to the three Process Validation Stages.
  • Understand the importance of Quality by Design and Quality Risk Management (QRM) in product and process design and validation strategy.
  • Able to develop a practical methodology to monitor process performance and product quality.
  • Able to identify the critical quality attributes and parameters that should be evaluated at a heightened level during stage 3 of process validation.
  • Understand the challenges to the application of an entire science- and risk-based approach.
  • Apply process performance and product quality monitoring system elements to identify opportunities for continual improvement.
  • Develop tools to prepare for a smooth validation execution.
  • Identify and understand the consequences of validation deviations.
  • Develop an 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.
Participants will understand how all Qualification & Validation (Q&V) activities will interact together within the same department or among different departments to achieve an ideal team-work spirit and integrity.

Others Training Materials

Workshop materials will be provided

Target group

  • -

    Trainer Languages English/Arabic

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