According to FDA inspectional observations, pharmaceutical firms have received more than one thousand warning letters (483) due to deficiencies in their environmental monitoring systems. Our experts, Giulia Artalli and Daniele Pandolfi, will discuss these findings and explain how they can be avoided in accordance with the latest EU EudraLex vol. 4 - GMP Annex 1 and ISO 14644.
This webinar will provide insights into how to enhance your Contamination Control Strategy (CCS), improve data management practices, develop continuous microbial active monitoring protocols, and effectively handle tubing length requirements (14644-21) using appropriate tools.
Key Learning Objectives
- Data Quality and CFR21 Part 11 best practices
- Continuous microbial monitoring strategies according to new Annex 1
- How to leverage system automation to ensure compliance
- Mastering the particle sampling tubing length challenge
- Data trending for viable and non-viable particles as a key element for your decision process
