Risk Based Approach for Pharmaceutical Process Validation & Relevant Documentations

Engineering and Validation

Operations

Quality

rd

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

Description

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