The 2nd Annual EandL conference will be covering practical case studies and brainstorming sessions on how to overcome regulatory, analytical, RandD and formulation challenges.
After the overwhelming response for our Mumbai and Hyderabad event, CPhI is now delighted to bring to you Pharma Extractables and Leachacbles Conference 2013 taking place from 24-26 July in Mumbai.
This year the focus will be on practical case studies covering:
Step- wise approach of performing EandL study for PODP, OINDP’s and ophthalmic
Identifying EandL from production process or intermediate storage and integrating QbD with EandL approach
Updates on PQRI recommendations for EandL in combination products and biologics
Discussion on the USP chapter for EandL and developing a tactical approach
Importance of selecting the extraction techniques and establishing the significance of Analytical Evaluation Threshold (AET)
Toxicological review in EandL data and risk mitigation strategy to reduce or tackle EandL
Plus! One day seminar on 26 July - “Single-use systems” focusing on key principles and concepts, use, qualification and validation of single-use systems for the benefit of pharma and biopharma industry.