Co-Located Conference AgendasAdvances in Food and Beverage Analysis | PharmaAQ |
Thursday, 11 October 201808:00 | Registration | 09:00 | Inauguration | 09:10 | Introduction of Resource Persons and Memento Presentation | 09:25 | Business Networking Session | 09:40 | Group Photograph | 09:50 | Coffee Break and Networking in Exhibition Area | | Plenary Talk |
| | 10:20 | 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 | | Scientific Session I - Management in Analytical R&D |
| | 11:20 | 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.
| 11:50 | 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. | | Scientific Session II - Analytical Method Development & Validation | Session Sponsors |
| | 12:20 | Analytical Method Development and Validation Yogita Kodgule, Director - Chief Analytical & Regulatory Affairs, IQGEN-X Pharma, India
| 12:50 | Elemental Impurities by ICP-MS P Radha Krishnanand, Associate Director-Business Development, Daicel Chiral Technologies
| 13:20 | A New Approach towards Chromatographic Method Development for Pharma Industry K K Bhagchandani, Director, Advanced Chemistry Development Inc
| 13:50 | Lunch Break and Networking in Exhibition Area | | Scientific Session III - Analytical Considerations During Drug Development | Session Sponsors |
| | 14:45 | Handling Sample Preparation Criticality during Drug Development and Beyond Manohar Sonanis, Ex- Vice President and Head, Lyrus Life Sciences Pvt Ltd, India
| 15:15 | Analytical Considerations during Drug Development Ajit Godbole, Managing Director, Anant Pharmaceuticals Pvt Ltd
| 15:45 | Coffee Break and Networking in Exhibition Area | | Workshop on Data Analytics | Session Sponsors |
| | 16:05 | 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 | 16:10 | Tutor David Wang, Principal Data Scientist, Sartorius Stedim Data Analytics, Singapore
| 16:12 | Tutor Vaibhav Patil, Sr. Data Scientist, Sartorius Stedim Data Analytics, India
| 18:00 | End of Day One of Conference |
Friday, 12 October 2018 | Scientific Session IV - Analytical Considerations for Stability of Pharmaceutical and Biopharmaceutical |
| | 09:00 | Stability Studies Challenges and their Solutions of Various Formulations Harvinder Singh, Head - Analytical R&D, IPCA Laboratories Ltd, India
| 09:30 | 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
| 10:00 | Role of Advanced Analytics -Mass Spectrometry in Monoclonal Antibody (mAb) Stability Assessment Ravi Krovidi, Lead Investigator - Biopharmaceutical Development, Syngene International Ltd, India
| 10:30 | Coffee Break and Networking in Exhibition Area | | Scientific Session V - Recent Trends in Bioanalytical Method |
| | 11:00 | Bioanalytical Method Development, Validation, and Clinical Sample Analysis Manoj Shukla, Vice President Operations, Panexcell Clinical Labs Pvt Ltd, India
| 11:30 | Green Bioanalytical Lab - A Vision of Bioanalytical Entrepreneur Manish S Yadav, CEO, ETHIXINN Consulting & Research Solutions, India
| | Scientific Session VI - Leveraging Analytical QbD for Method Development |
| | 12:00 | QbD Approach for Analytical Method Development (Analytical QbD) Bhaskar Kolte, Associate Director -ARD, Perrigo Laboratories India Pvt. Ltd., India
| 12:30 | 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. | 13:00 | 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. | 13:30 | Lunch Break and Networking in Exhibition Area | | Scientific Session VII - PAT Applications in Quality Control |
| | 14:15 | 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. | 14:45 | 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
| 15:15 | Coffee Break and Networking in Exhibition Area | | Scientific Session VIII - Current Challenges in Quality Management |
| | 15:40 | Data Reliability - A Growing Concern in Pharmaceutical Industry Arun Mendiratta, Associate Vice President, Aurobindo Pharma, India
| 16:10 | Advanced Aseptic Behavior and Challenges Anil Fokmare, Head- Quality (Formulation-Unit 3), Alembic Pharmaceuticals Ltd., India
| 16:40 | Conference Feedback | 16:50 | Closing Remarks and Vote of Thanks | 17:00 | End of the Conference |
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