PharmaAQ Agenda

Registration

Inauguration

Introduction of Resource Persons and Memento Presentation

Business Networking Session

Group Photograph

Coffee Break and Networking in Exhibition Area

Nondestructive Pharmaceutical Analysis and Visualization
Saranjit Singh, Professor/Head, NIPER Mohali, India

This talk will be focused on nondestructive pharmaceutical analysis, process analytical technologies (PAT), and pharmaceutical visualization. The major techniques involved include Attenuated Total Reflectance (ATR); Near Infrared (NIR), FT-Raman, Terahertz, X-Ray, Quadrupole Resonance (QR) Spectroscopy, Frequency Modulation Spectroscopy (FMS), TOF-SIMS, etc

Analytical Procedure Lifecycle - USP <1220>
Mrunal Jaywant, Senior Director, USP India Private Limited, India

USP has proposed new general chapter “<1220> The Analytical Procedure Lifecycle” to address the entire procedure lifecycle and to define concepts. Dr Jaywant will explain and discuss about this new general chapter <1220> which will provide guidance to facilitate the management of post-approval changes in a more predictable and efficient manner across the product life cycle and it will promote innovation and continual improvement, and strengthen quality assurance and reliable supply of a product.

Analytical Method Transfers – Best Practices and Challenges
B M Rao, Vice President & Head – ASAT & CQC, Dr Reddy's Laboratories, India

A successful AMT requires accurate communication between the transferring and receiving laboratories and a clear plan with defined roles and responsibilities. But the most important takeaway is to never treat an AMT as a checkbox routine. Differences in instrumentation, techniques, procedures and even interpretations of an analytical procedure can lead to preventable AMT failures. Dr Rao will extensively cover some of the best practices to be adopted during AMTs and how to address the key challenges. 

Analytical Method Development and Validation
Yogita Kodgule, Director - Chief Analytical & Regulatory Affairs, IQGEN-X Pharma, India

Elemental Impurities by ICP-MS
P Radha Krishnanand, Associate Director-Business Development, Daicel Chiral Technologies

A New Approach towards Chromatographic Method Development for Pharma Industry
K K Bhagchandani, Director, Advanced Chemistry Development Inc

Lunch Break and Networking in Exhibition Area

Handling Sample Preparation Criticality during Drug Development and Beyond
Manohar Sonanis, Ex- Vice President and Head, Lyrus Life Sciences Pvt Ltd, India

Analytical Considerations during Drug Development
Ajit Godbole, Managing Director, Anant Pharmaceuticals Pvt Ltd

Coffee Break and Networking in Exhibition Area

Workshop: This Workshop focuses on analysing different types of from various sources (People, Instruments like NIR, NMR, Mass Spec, Wet Chemistry, sensors, Process) and combining them to predict final quality, safety and efficacy of produced goods. For details, follow link http://selectbiosciences.com/conferences/workshopsID.aspx?WID=64&conf=PAQ18&se=india

Tutor
David Wang, Principal Data Scientist, Sartorius Stedim Data Analytics, Singapore

Tutor
Vaibhav Patil, Sr. Data Scientist, Sartorius Stedim Data Analytics, India

End of Day One of Conference

Stability Studies Challenges and their Solutions of Various Formulations
Harvinder Singh, Head - Analytical R&D, IPCA Laboratories Ltd, India

Kinetic Modeling of Accelerated Stability Studies for Predicting Drug Product Stability
Gautam Samanta, Vice President - Quality by Design and Process Scale-up, Cipla Ltd, India

Role of Advanced Analytics -Mass Spectrometry in Monoclonal Antibody (mAb) Stability Assessment
Ravi Krovidi, Lead Investigator - Biopharmaceutical Development, Syngene International Ltd, India

Coffee Break and Networking in Exhibition Area

Bioanalytical Method Development, Validation, and Clinical Sample Analysis
Manoj Shukla, Vice President Operations, Panexcell Clinical Labs Pvt Ltd, India

Green Bioanalytical Lab - A Vision of Bioanalytical Entrepreneur
Manish S Yadav, CEO, ETHIXINN Consulting & Research Solutions, India

QbD Approach for Analytical Method Development (Analytical QbD)
Bhaskar Kolte, Associate Director -ARD, Perrigo Laboratories India Pvt. Ltd., India

Optimization of a Liquid Chromatography Method for the Analysis of Related Substances using Design of Experiments Integrated with the Steepest Ascent Method and Monte Carlo Simulation
Trupti Tol, Associate Director, Cipla Ltd, India

An analytical method for the determination of related substances (RS) was optimised using quality by design (QbD) approach. The DoE study uncovered hidden peaks and unknown criticalities, which would eventually lead to method and product failure.  Since this was a sensitive case of method development it was treated accordingly, and techniques such as method of steepest ascent were adopted to attain the optimum condition. Finally, the method robustness was proved and fortified through capability analysis and Monte Carlo simulations and this is going to be a focus of Ms Tol’s talk.

Interactive Session: This is a specially designed informal open session in which the delegates will get an opportunity to interact with the experts/speakers in an informal open session.

Lunch Break and Networking in Exhibition Area

Continuous Manufacturing and Real-time Release Testing
Rameshwar Nalawade, Head - Quality and Analytical Development, STEERLife India Pvt Ltd, India

Continuous manufacturing can offer significant quality and cost advantages over batch manufacturing of pharmaceutical drugs and drug products. Real time release testing is a best system for continuous manufacturing. Dr Nalawade in his talk will focus on continuous manufacturing through real time release testing with respect to Process Quality by design and Analytical quality by design in pharmaceutical development.  

Implementation of Process Analytical Tools (PAT)-Raman and NIR in Pharmaceutical Development
Mallikarjun Narayanam, Senior Research Investigator, Biocon Bristol Myers-Squibb R&D Center, India

Coffee Break and Networking in Exhibition Area

Data Reliability - A Growing Concern in Pharmaceutical Industry
Arun Mendiratta, Associate Vice President, Aurobindo Pharma, India

Advanced Aseptic Behavior and Challenges
Anil Fokmare, Head- Quality (Formulation-Unit 3), Alembic Pharmaceuticals Ltd., India

Conference Feedback

Closing Remarks and Vote of Thanks

End of the Conference