Thursday, 16 April 2015 |
Draft Agenda (Subject to Change) |
| | 07:45 | Registration | 08:45 | Inauguration | 09:40 | Opening Talk by Conference Chair: Ominipresence of QbD during Drug Product Life Cycle
Bhupinder Singh Bhoop, Dean, UIPS, Panjab University, India
| 10:30 | Coffee Break and Networking in Exhibition Area | |
Session 1: QbD in Drug Development / Session Chair: Anurag Rathore |
| | 11:00 |  | Keynote Presentation Complexity in Pharmaceutical Systems
Brian Carlin, Director, FMC BioPolymer, United States of America
This Presentation will discuss various methods that helps in minimizing the impact of uncertainty/variability on quality attributes. Further, it will also demonstrate its relevant diligence on filing. |
| 11:40 | Q/A Session | 11:45 | Development of Scientifically Sound Control Strategy for Drug Substance
Sushil Srivastava, Process Research and Development Director, Bristol-Myers Squibb, United States of America
In this talk risk based approach will be discussed for efficient development of the DS control strategy. This talk will cover the following points: Identification of Critical Quality Attributes of the drug substance,Understanding of formation and purge of the impurities, Identification and control limits of parameters impacting quality,
Setting up appropriate specifications for SMs and intermediates to ensure quality,Verification of control strategy, Defining the scientifically sound control strategy.
| 12:15 | Q/A Session | 12:20 | Integration of Quality by Design from Product Development to API Production
Gautam Samanta, Vice President - Quality by Design and Process Scale-up, Cipla Ltd, India
A perspective of QbD application for new API development will be discussed. | 12:50 | Q/A Session | 12:55 |  Technology Spotlight:
Finding Robust Setpoint for Design Space Using DOE and Monte Carlo Simulations
Nirav Shah, Senior Application Specialist, Umetrics
| 13:10 | Poster Viewing | 13:30 | Lunch Break and Networking in Exhibition Area | |
Session 2: QbD for Holistic Pharma Develoment / Session Chair: Krishna Venkatesh |
| | 14:30 | Identifying and Understanding the Role of Qbd in Analytical Method Development and Validation
Dinesh Kumar, Associate Vice President, Alkem Laboratories Ltd, India
The talk will cover following specifics, 1. QbD current reality, 2. QbD framework for process versus Analytical methods, 3. ATP and CQA for Analytical methods, 4. Risk Assessment in AQbD 5. Design Space for Analytical methods 6. Why we need AQbD | 15:00 | Q/A Session | 15:05 |  Technology Spotlight:
Making Chemically Intelligent Choices for HPLC Method Development
K K Bhagchandani, Director, Advanced Chemistry Development Inc
| 15:20 | Implementation of QbD for Biopharmaceuticals: Tools and Case Studies
Anurag Rathore, Professor, Indian Institute of Technology Delhi, India
This talk will focus on some of the tools that play a critical role in implementation of QbD for biotech processes. Real case studies have been used to elucidate this. Tools that will be discussed include Process Analytical Technology (PAT), multivariate data analysis (MVDA), design of experiments (DOE), high throughput process development (HTPD), mechanistic modeling and computational fluid dynamics (CFD). | 15:50 | Q/A Session | 15:55 | PAT & Chemometric Tools in QbD
Paras P Jain, Group Leader, Ranbaxy Laboratories Ltd, India
In this talk, Process Analytical Technology will be briefly introduced and appropriate chemometric methods along with their advantages and principle will be discussed. | 16:25 | Q/A Session | 16:30 | Coffee Break and Networking in Exhibition Area | 17:00 | | 17:40 | Q/A Session | 17:45 | End of First Day of Conference | 19:00 | Networking Dinner |
Friday, 17 April 2015 |
Session 3: QbD for Product Development Excellence / Session Chair: Sushil Srivastava |
| | 09:00 | Formulation by Design
Nitin Kadam, General Manager, T&T Pharma Care Pvt Ltd, India
| 09:30 | Q/A Session | 09:35 |  | Keynote Presentation QbD – Applications in Controls, PAT, Continuous Improvement and Productivity
Krishna Venkatesh, Vice President, Dr Reddy's Laboratories Ltd, India
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| 10:25 | Q/A Session | 10:30 | Coffee Break and Networking in Exhibition Area | |
Session 4:Vital Pharma QbD Tools: DoE, MVDA & Beyond / Session Chair: Bhupinder Singh Bhoop |
| | 11:00 | DoE & Development of Design Space for Pharmaceutical Product Development as per QbD with alive cases of Solid Orals, Liquid Orals, Semisolids & Parenteral Dosage Forms
Shivang Chaudhary, Formulation Engineer & Patent Attorney, Indian Institute of Management Ahmedabad, India
This presentation will help to gain technical experience on how to utilize tools of QbD i.e. DoE & PAT & how to implement it systematically & effectively during development & manufacturing of Solid Oral dosage forms (Tablets/ Capsules) as well as Liquid Orals/ Semisolids (Solution/ Suspension/Emulsion) & Parenteral/ Sterile Dosage forms i.e. Eye/Ear/Nasal Drops, SVP & LVP. | 11:30 | Q/A Session | 11:35 | Using DoE under Real-Life Restrictions
Philippe Solot, Chief Executive Officer, AICOS Technologies AG, Switzerland
| 12:05 | Q/A Session | 12:10 | Statistics in Product Development- Beyond DoE
Jasmine , Senior Scientist, Dr Reddy's Laboratories Ltd, India
The talk will be about the use of other Statistical tools to build Robust Products & Processes. These tools include but are not limited to Artificial Neural Networks, Monte Carlo Simulation, Multi-Variate Analysis etc. | 12:40 | Q/A Session | 12:45 | Using Multivariate Data Analysis to Quantify Physicochemical Properties of Excipients
Nirav Shah, Senior Application Specialist, Umetrics, United States of America
| 13:15 | Q/A Session | 13:20 | Poster Viewing | 13:40 | Lunch Break and Networking in Exhibition area | |
Session 5: QbD Applications for Fortifying Improved Pharma Deliverability / Session Chair: Brian Carlin |
| | 14:40 | | 15:20 | Q/A Session | 15:25 | Application of Quality by Design (QbD) Approach In Formulation of Oral Delayed Release Tablet of Lansoprazole
Gayatri Patel, Associate professor, Ramanbhai Patel College of Pharmacy, India
This presentation will discuss the use of risk assessment tool along with experimental design to provide an effective and efficient paradigm to build the quality into oral delayed release tablet. | 15:45 | Q/A Session | 15:50 | Analytical Quality by Design (AQbD) Approach in RP-HPLC Method Development for the Assay of Etofenamate in Dosage Forms by Central Composite Deign (CCD)
Ramalingam Peraman, Assistant Professor , Gulf Medical University, United Arab Emirates
| 16:10 | Q/A Session | 16:15 | Demonstration of Multivariate Data Analysis for the QbD based Systematic Development of Nanoemulsions containing Boswellia serratta with Enhanced Topical Delivery.
Asha Patel, Associate Professor, Parul University, India
| 16:35 | Q/A Session | 16:40 | Poster Award Presentation & Vote of Thanks | 16:50 | Coffee Break and Networking in Exhibition Area | 17:30 | Evening Sightseeing Tour |
Saturday, 18 April 2015 |
Software Training Programme |
| | 08:30 | Systematic Method Development & QbD by ACD/Labs
K K Bhagchandani, Director, Advanced Chemistry Development Inc
| 10:15 | Coffee Break | 10:30 | Design of Experiment (DOE) and Multivariate Data Analysis (MVDA) for Pharmaceutical QbD and PAT using MODDE and SIMCA
Nirav Shah, Senior Application Specialist, Umetrics
| 13:00 | Lunch Break | 14:00 |  Quick and Easy DoE using STAVEX
Philippe Solot, Chief Executive Officer, AICOS Technologies AG
| 15:30 | Coffee Break | 15:45 |  Formulation by Design using Minitab 17.
Bimal Kesh, Senior Statistician, Minitab India
| 17:15 | End of Software Training Programme |
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