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PHARMA EXTRACTABLES AND LEACHABLES 2012
With the ever-growing regulatory complexities and unclear guidelines around extractables and leachables, pharma companies are struggling to identify cost-effective solutions for fulfilling regulatory expectations and achieving swift product approvals.
 
Also 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.
 
Attend Pharma Extractables and Leachables 2012 taking place from 21-23 August 2012 and prepare for SAVING ON HUGE COSTS
 
Dont miss out on this must-attend conference that will delve deeper into:
 
Regulations
  • Clarifying and updating on PQRI, EMEA, FDA, ASEAN and Japanese guidelines with practical case study insights
  • Understanding methods of approach and specific documentation for E&L
  • Learning best practices to charaterise and assign limits to extractable and leachable impurities
 
Analytical
  • Cost effective and time saving analytical techniques of identification and extraction of extractables and leachables
  • Safety qualification process and overcoming challenges around low level of quantification (LOQ)
  • Toxicological Risk Assessment
 
Plus a unique pre-conference seminar on E&L challenges in formulations covering indepth insights on:
  • Understanding the importance of extractables and leachables study and sucessfully dentifying its potential sources
  • Undertaking successful compatibility study of product with its packaging material
  • Adopting a systematic quality control approach for new product development
 
A not-to-be-missed event for practical knowledge seekers including Directors, Senior Directors, Heads, Presidents, Vice-Presidents, Senior Managers, Managers, General Managers in the field of Regulatory Affairs, QA/QC, R&D and Formulations Development
 
     
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