Creating Mindset for Implementation of Quality by Design and Enacting Pharmaceutical Quality

Workshop by Dr Mandar Kodgule, Senior VP, Global IP & Corporate Strategy, Wockhardt Ltd

The global Pharmaceutical market is touching $700 Billion in 2017 and is expected to grow at 8-10% annually over next decade. While there are several opportunities to grab, the concerns over efficacy and patient safety are rapidly growing as well. The “Culture of Quality” needs strengthening. It requires a significant change in mindset, which can be only brought about by creating strategies, thinking differently and by managing knowledge. Quality by Design is nothing but providing a solution to problem, “How we know, what we know?”

In this workshop we will first focus on creating the right mindset for understanding of QbD and Pharmaceutical Quality. The first part will focus on
1.What is Strategy
2.Lateral Thinking
3.What we really know? Why we fail?
4.What is First Time Right? What are the advantages of FTR?
5.What is Quality by Design? How to apply the concepts in product development, regulatory submissions, analytical development and commercialization?
6.Process Analytical Technology tools for real time release testing, understanding of processes and products
7.What are the common issues the industries are facing today?

There will be three to four interesting case studies, which the participants have to debate, discuss in team and present their solution.

About the Workshop Facilitator

Dr Mandar Kodgule is M Pharm, PhD (Tech) from Bombay College of Pharmacy. He also completed his degree in “Advance Management and Leadership” from University of Oxford. He has worked for about 20 years in Innotech Pharma, Ranbaxy Laboratories and Wockhardt in the area of Computer Aided Drug Designing, Chemical Research and Tech transfer, Formulation Development, Regulatory Affairs, Intellectual Property, Business development, Corporate Strategy and Strategic Alliances. He is inventor in 87 patents of which 11 are granted Globally. He has about 5 International Research Publications. He is PhD Guide with University of Pune, BVDU and Jodhpur University. He is member of CII, FICCI, IPA, IDMA and Pharmexcil.

Details of the workshop:
Date: 22nd October, 2016
Day: Saturday
Time: 10:00am to 3:30pm
Registration fees: ₹50
Registration limit: 60 participants
Venue: GE101, ICT, Mumbai

For registrations contact:
Mangesh Sane: +91 99 87 171701
Tanishka Saraf: +91 9619250977

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