Risk Based Approach for Pharmaceutical Process Validation & Relevant Documentations
- 3 days (2 days can be customized)
- Course fee
Science and Risk-Based Approach to Pharmaceutical Process Validation
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.
Others Training Materials
Workshop materials will be provided
Trainer Languages English/Arabic