This webinar will discuss the requirements and general expectations for Stage 2 - Process Qualification, the key concepts that lead to the basis of confidence level and/or statistical confidence and how to apply the concepts in practical use for validation, including acceptance criterion.
Why should you Attend
- This 90-minute session will provide an overview of Stage 2 - Process Validation - using practical examples that you can apply when validating your products. We will discuss the approaches and statistical calculations required to execute Stage 2 - Process Qualification - based upon statistical confidence. The instructor will provide examples for practical application of the determination of sample size, confidence, and process capability when balancing risk. You will learn how to connect the guidance and requirements for statistical confidence to statistical rationale, deliverables, and validation acceptance criterion that can stand the challenge of an audit.
Areas Covered in the Webinar:
Overview of FDA Guidance
- Process Capability
- Process Stability
Definitions and Concepts that Lead to the Basis of Confidence Level and Statistical Confidence
- Confidence Level
- Risk and Confidence Level
- Example Confidence Equations
- Application of ASTM E2281-08a (2012) Standard Practice for Process and Measurement Capability Indices
- Minimum Batches vs Confidence Level
- Statistical Rationale Examples
- PPQ Examples including Acceptance Criterion with Statistical Confidence
Who Will Benefit:
This webinar is targeted mainly to manufacturers of pharmaceutical products and biopharmaceuticals. The personnel who will benefit include:- Validation Managers
- Validation Engineers
- QA and Auditing Professionals
- Regulatory Professionals
- Scientists
- Product, process and formulation development
- Personnel in analytical development
Course Provider
Marvin Iglehart,
