Extractables & Leachables

Time:July 24-25, 2013

Country&Region: India

Venue:Holiday Inn International Airport,Mumbai

Organizer:UBM India

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.

With a number of products requiring E&L studies are soon going off-patent and hence generic companies are looking at feasible solutions to minimise their costs for E&L testing.

Now is the right time to prepare for the future and revamp your strategies to avoid incurring huge losses due to inappropriate and untimely E&L studies.

This year the focus will be on practical case studies covering:

Step- wise approach of performing E&L study for PODP, OINDP’s and ophthalmic
Identifying E&L from production process or intermediate storage and integrating QbD with E&L approach
Updates on PQRI recommendations for E&L in combination products and biologics
Discussion on the USP chapter for E&L and developing a tactical approach
Importance of selecting the extraction techniques & establishing the significance of Analytical Evaluation Threshold (AET)
Toxicological review in E&L data and risk mitigation strategy to reduce or tackle E&L

Contact:UBM India

Tel:+91 (022) 61727001 / 022 61727272

Website:http://www.extractablesandleachables.com/

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