Insights into NEW ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, and Controls Webinar
Learning Level: Basic/Intermediate/Advanced
This Webinar summarizes the recently published ISPE Guide on Cleaning Validation. It will present the guide topics, key principles and current approaches for the implementation of compliant cleaning programs.
Learning Objectives :
- Understand the new ISPE Guide scope, content, and applicability.
- Review a summary of the guide content; chapter by chapter.
- Identify approaches to establish cleaning programs that meet or exceed regulatory expectations.
This ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations. Topics covered include:
- Application of risk management
- Adoption of a lifecycle approach for cleaning validation
- Cleaning methodologies
- Creation of cleaning validation acceptance criteria
- Determination of visual inspection limits
- Calculation and justification of residue limits
- Validation of testing and sampling methods
- Equipment issues and challenges
- Change Management