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QbD in Pharma Development 2014

QbD in Pharma Development 2014



We are delighted to announce our 2nd International conference on “QbD in Pharma Development” with the theme "Excellence and Compliance using QbD" scheduled to be held on February 24-25, 2014 in Ramada Powai Hotel and Convention Centre, Mumbai, India. This event is especially designed to discuss the implementation case studies, success stories and issues and challenges faced while implementing QbD principles at industry level.   

The federal agencies have reiterated to build quality into the products during multi-phase product development life cycle and eventually, enhance product and/or process understanding, all using the rational and systematic approach of QbD. The key elements of QbD including the QTPP, CQAs, QRM, CMA, CPP and control strategy, as enumerated in the ICH guidelines, Q8, Q9, Q10 and Q11, are to be followed and implemented. The key regulatory agencies across the globe like US FDA, WHO, EMEA, Health Canada, MHA, TGA, PMDA and SFDA have adopted such ICH guidance per se. Besides being a federal requirement, QbD is fast emerging as a tangible tool to quicken time to reach market, reduce recalls and rejects, improve patient generic scepticism, minimise post-approval changes, streamline data flows across the entire life cycle of the drug, and above all, improve overall efficacy and cost-efficacy for patients and manufacturers alike.

This event will offer definitive benefits to the scientists from academia and industry working in the domains of Product Development, Process R & D, Scale-up, Manufacturing, Quality Assurance, Global Regulatory Affairs, API, Excipients, Pharmaceutical Analysis and Technology Transfer. The speakers will articulate on all the pertinent areas of QbD Implementation including API, Analytical Development, Excipients and Formulation.

Running alongside the conference will be our “Generics and Biologics 2014” meeting


Keynote Speakers

Ranjit Barshikar

Ranjit Barshikar
QbD/cGMP Consultant, Pharma Quality Management Consultants

Bhupinder Bhoop

Bhupinder Bhoop
Professor and Dean, Panjab University

Brian Carlin

Brian Carlin
Director, FMC Corporation

Mukesh Gohel

Mukesh Gohel
Research Director/Professor, LM College of Pharmacy

Ajaz Hussain

Ajaz Hussain
Consultant, Insight Advice & Solutions LLC

Krishna Venkatesh

Krishna Venkatesh
Vice-President, Product Development (OSD), Dr Reddy's Laboratories Ltd

Agenda Topics

  • Design Space Considerations: Where are We Currently?
  • DoE & Multivariate FbD Strategies for Product and Process Understanding
  • Implementation of QbD in API Development
  • QbD Applications in Developing NDDS and Biologics
  • QbD Case studies in the Light of Federal Perspectives
  • QbD for Optimizing Excipient Attributes
  • QbD Implementation in Product Development: Formulation by Design (FbD)
  • QbD in Product Life Cycle: Emerging Challenges and Issues
  • Quality Risk Management (QRM) tools during QbD Execution
  • Systematic QbD Approaches in Analytical Method Development

Sponsorship and Exhibition Opportunities

Ira Sood, Exhibition Manager
i.sood@selectbio.com
7696225050

Confirmed Speakers to date

Bhupinder Bhoop, Professor and Dean, Panjab University
Gautam Samanta, Associate Director, Dr Reddy's Laboratories Ltd
Jasmine , Senir Scientist, Dr Reddy's Laboratories Ltd
Sandip Tiwari, Technical Director, Colorcon Asia Private Limited
Anil Binnor, Head, IPCA Laboratories Ltd
Sushil Srivastava, Process Research and Development Director, Bristol-Myers Squibb
Adnan Sabir, QA-CMC Manager, Kowa Pharmaceuticals America Inc
Dakshesh Mehta, General Manager, Wockhardt Research Center
Khalid Ansari, Senior Research Investigator, Syngene International
Alicia Tebar, Project Manager, Telstar
Pradeep Karatgi, Co- Founder/Director, IDRS Labs Pvt Ltd
Arnab Kapat, Vice President and Head, Reliance Life Sciences Private Ltd


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