08:00 | 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 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> 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 | |
Scientific Session II - Analytical Method Development & Validation | Session Sponsors | |
12:20 | Analytical Method Development and Validation | |
12:50 | Elemental Impurities by ICP-MS | |
13:20 | A New Approach towards Chromatographic Method Development for Pharma Industry | |
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 | |
15:15 | Analytical Considerations during Drug Development | |
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 | |
16:12 | Tutor | |
18:00 | End of Day One of Conference |
Scientific Session IV - Analytical Considerations for Stability of Pharmaceutical and Biopharmaceutical | ||
09:00 | Stability Studies Challenges and their Solutions of Various Formulations | |
09:30 | Kinetic Modeling of Accelerated Stability Studies for Predicting Drug Product Stability | |
10:00 | Role of Advanced Analytics -Mass Spectrometry in Monoclonal Antibody (mAb) Stability Assessment | |
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 | |
11:30 | Green Bioanalytical Lab - A Vision of Bioanalytical Entrepreneur | |
Scientific Session VI - Leveraging Analytical QbD for Method Development | ||
12:00 | QbD Approach for Analytical Method Development (Analytical QbD) | |
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 | |
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 | |
14:45 | Implementation of Process Analytical Tools (PAT)-Raman and NIR in Pharmaceutical Development | |
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 | |
16:10 | Advanced Aseptic Behavior and Challenges | |
16:40 | Conference Feedback | |
16:50 | Closing Remarks and Vote of Thanks | |
17:00 | End of the Conference |