OverviewQuality Management systems of a Pharmaceutical company follow GMP guidelines and require that
the analytical methods, followed for drug analysis, are robust and are developed following all validation principles.
" Pharmaceutical Analysis and Quality" is a unique conference for the analytical scientists working in analysis of
small and large molecules. This is a Pharmaceutical Industry focused event and is designed to discuss advanced analytical
techniques like HPLC, Mass spectrometry etc., analytical method development, analytical techniques in biotechnology and
many more. These techniques are followed as per WHO or ICH or FDA guidelines for assay development, thereby ensuring
quality of pharmaceutical products. This event will include discussions by Industry Experts from
Pharmaceutical analysis and quality control fields, covering topics like analytical techniques, including HPLC, Mass, NMR,
Raman, Hybrid instrumentation and software solutions to analytical problems, QbD approaches, validation parameters,
analytical errors, meaningful data analysis etc. The organizers envisage to bring more and more overseas and industry
scientists as speakers so that the delegates are able to derive maximum benefit from their
expertise. Registration by Overseas Delegate: Overseas Industry Delegate, who wish to participate and
pay by Credit Card issued outside India, please click on REGISTER NOW or for Wire Transfer details, please write to Ms. Pooja Sharma, Email: p.sharma@selectbio.in
or Call: +91 7696325050, 7696525050 or WhatsApp: 9041725050) For registration support, please write to
Ms Farheen Zainab at f.zainab@selectbio.in or call 7696125050, 7696525050.Delegate Profile:
President, Vice-President, Director, Managers and Scientist from Pharmaceutical Company or CRO working in the following
departments- Analytical/Bio-analytical Method Development, Analytical R & D, Quality Control, Quality Assurance,
Analytical Chemistry, API Quality, Stability testing, Drug Discovery and Development
etc. Exhibition/Sponsorship: Exhibition/Sponsorship Opportunities are available. For details, please
contact the Exhibition Manager at mjsingh@selectbio.in or call 7696225050, 7696525050 or WhatsApp:
9041725050.
HANDS-ON WORKSHOP ON DATA ANALYTICSAlso attend our 2-Hours Hands-on Workshop on Data Analytics. This workshop will focus on analyzing different types of data from various instruments like NIR, NMR, Mass Spec, etc. Wet Chemistry, sensors, Process and combining them to predict final quality, safety and efficacy of produced goods. The workshop is Free for Registered Delegates of this Conference.
Session Sponsors
Agenda Topics- Analytical Considerations during Drug Development
- Extractables and Leachables
- HPLC, MS, NMR, Electrochemical Methods
- Hyphenated HPLC & Hybrid Methods
- Solid-state Analysis & Polymorphism
- Vibrational Spectroscopy, Chiral Analysis
- Analytical Errors and Meaningful Data Interpretation
- Analytical Method Development and Validation
- HPLC, Biopharmaceutical & QbD Methods
- OOS/OOT Results
- Solution Stability, Stability Indicating, Validation
- Specificity, Accuracy, Robustness of Methods
- Bioanalytical Method Development, Validation, and Clinical Sample Analysis
- Bioanalysis of Small and Large Molecules: PK/TK Determinations, Drug Metabolism
- Emerging Technologies and Automation in Bioanalysis
- Chromatography and Separation Techniques
- HPLC, Hyphenated HPLC, Instrumentation
- GMP/GLP and Regulatory Audits
- Pharmaceutical Microbiology
- Water Sterility and Quality
- Quality Control and Assurance Strategies
- PAT, QRM, QbD Approaches
- Quality Control Systems, Quality Assurance Strategies
- Techniques and Instrumentation for Analysis & Bioanalysis
- Analysis by Mass Spectrometry, NIRS, NMR, Thermal, Raman Spectroscopy
- Hybrid Techniques and Automation
- Stability Sample Analysis - Special Considerations
Sponsorship and Exhibition OpportunitiesManinderjit Singh, Exhibition Manager mjsingh@selectbio.com 7696225050
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Confirmed Speakers to dateK K Bhagchandani, Director, Advanced Chemistry Development Inc Anil Fokmare, Head- Quality (Formulation-Unit 3), Alembic Pharmaceuticals Ltd. Ajit Godbole, Managing Director, Anant Pharmaceuticals Pvt Ltd Mrunal Jaywant, Senior Director, USP India Private Limited Yogita Kodgule, Director - Chief Analytical & Regulatory Affairs, IQGEN-X Pharma Bhaskar Kolte, Associate Director -ARD, Perrigo Laboratories India Pvt. Ltd. Ravi Krovidi, Lead Investigator - Biopharmaceutical Development, Syngene International Ltd Arun Mendiratta, Associate Vice President, Aurobindo Pharma Rameshwar Nalawade, Head - Quality and Analytical Development, STEERLife India Pvt Ltd Mallikarjun Narayanam, Senior Research Investigator, Biocon Bristol Myers-Squibb R&D Center Vaibhav Patil, Sr. Data Scientist, Sartorius Stedim Data Analytics P Radha Krishnanand, Associate Director-Business Development, Daicel Chiral Technologies B M Rao, Vice President & Head – ASAT & CQC, Dr Reddy's Laboratories Gautam Samanta, Vice President - Quality by Design and Process Scale-up, Cipla Ltd Manoj Shukla, Vice President Operations, Panexcell Clinical Labs Pvt Ltd Harvinder Singh, Head - Analytical R&D, IPCA Laboratories Ltd Saranjit Singh, Professor/Head, NIPER Mohali Manohar Sonanis, Ex- Vice President and Head, Lyrus Life Sciences Pvt Ltd Trupti Tol, Associate Director, Cipla Ltd David Wang, Principal Data Scientist, Sartorius Stedim Data Analytics Manish S Yadav, CEO, ETHIXINN Consulting & Research Solutions
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Corporate Sponsors
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Media Sponsors
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Official Journal Partner
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Networking
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