Best Practices for Implementing Effective Cleaning Validation using ASTM E3106-17 Principles
Date : November 6, 2019
Time : 11.00 AM EST
“Cleaning, in and of itself, is a relatively simple process; yet under pressures of inspectional scrutiny, and the reactionary programs created by the industry to address regulatory concerns, the verification of cleaning has transformed into complex, expensive and time-consuming activity.” – Development and Validation Draft 2013.
Our expert, Igor Gorsky will show you how to develop and implement the best risk assessment-based approach to Cleaning Validation using ASTM E3106-17 Principles.
Why you should attend
If you are a professional who is involved in the development of pharmaceutical and biopharmaceutical product and process cleaning procedures throughout a drug’s lifecycle, then this webinar is for you. During this session we will discuss the role of Quality Risk Management (QRM) in the development of cleaning process programs and cleaning verification and validation programs. We will also discuss regulatory validation guidance and show how QRM should be utilized in the implementation of a risk-based lifecycle approach to cleaning validation. We will touch upon the use of statistics in the cleaning validation process and talk about continued verification and monitoring. Our focus will be on the risk-based approach as it is the cornerstone of cleaning process validation principles and practices.
The implementation of QRM is a regulatory requirement. Cleaning Validation is also a regulatory requirement as well as expectation. Robust and compliant cleaning validation programs make perfect business sense for successful manufacturing facilities, and learning how to use QRM in cleaning processes/cleaning validation programs will be of tremendous help to practitioners.
You will learn how to
- Implement a consistent cleaning process through all stages – development, validation and maintenance using a risk-based approach
- Stay compliant with worldwide GMPs
- Systematically apply quality principles across your entire product lifecycle
- Develop a Control Strategy across product, process, and variables that will give you the confidence to get into commercial manufacturing
…and so much more!