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
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
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
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
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
16:12
Tutor Vaibhav Patil, Sr. Data Scientist, Sartorius Stedim Data Analytics
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
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
10:00
Role of Advanced Analytics -Mass Spectrometry in Monoclonal Antibody (mAb) Stability Assessment Ravi Krovidi, Lead Investigator - Biopharmaceutical Development, Syngene International Ltd
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
11:30
Green Bioanalytical Lab - A Vision of Bioanalytical Entrepreneur Manish S Yadav, CEO, ETHIXINN Consulting & Research Solutions
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.
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
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
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
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