Navigating Complexities in Pharmaceutical Analysis, Quality & Regulatory Compliance
Overview
In the highly regulated pharmaceutical landscape, ensuring the quality, safety, and efficacy of drug products hinges on meticulous analysis, robust quality systems, and strict adherence to regulatory guidelines. Among the multifaceted challenges faced by pharmaceutical scientists, the control and characterization of impurities, the mitigation of nitrosamine risks, the assessment of extractables, leachables, and the establishment of product stability are paramount.
This critical domain requires a deep understanding of advanced analytical techniques, evolving regulatory expectations, and proactive risk management strategies. The identification, quantification, and qualification of various types of impurities – be they organic, inorganic, residual solvents, or elemental – demand sophisticated methodologies and a thorough grasp of ICH guidelines (Q3A, Q3B, Q3C, Q3D). Furthermore, the recent emergence of nitrosamines as a significant safety concern necessitates a comprehensive understanding of their formation pathways, effective risk assessment protocols, and sensitive analytical detection methods (ICH M7).
Successfully navigating these complexities demands a holistic approach, integrating cutting-edge analytical tools, a strong quality mindset, and a thorough understanding of global regulatory expectations. Pharmaceutical professionals must continuously update their knowledge and skills to effectively address these critical aspects and ensure the delivery of safe and effective medicines to patients.
Conference Dates
06-11-2025 to 07-11-2025
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Conference Agenda
- Challenges in Pharmaceutical Analysis
- Control of Nitrosamine & NDSRI Impurities
- Analytical Detection of Nitrosamine & NDSRI Impurities
- Analytical Considerations for Extractables & Leachable
- Stability Studies and Shelf-Life Determination
- Regulatory Expectations for Impurities and Stability
Who should attend
- Analytical Scientists
- Quality Control (QC) Analysts and Managers
- QA Specialists and Managers
- Regulatory Affairs Professionals
- Formulation Scientists
- Stability Scientists
- Team Leaders and Directors
- OOS/OOT Investigators
Conference Officials
WhatsApp: 9041725050
Speakers & Panelists
Consultant and Retired -Head– Analytical Development,
SUN Pharmaceuticals,
India
Senior Director,Analytical Services Department,
Daicel Chiral Technologies India Pvt. Ltd.,
India
Director – Analytical Research & Development (Global),
Simson Pharma Limited,
India
Venue
Ginger Mumbai Airport
Address: Nehru Road, Plot no 10&11, Western Express Hwy, Navpada, Vile Parle East, Mumbai, Maharashtra 400099
Discover a world of lean luxe charm with Ginger Hotels! Whether you’re here for business or leisure, Ginger Mumbai Airport offers the perfect blend of comfort, convenience, and community. Located just 1 km from Terminal 1 and about 3 km from Terminal 2, it stands out as one of the most well-connected hotels near Mumbai airport, making it easy for travelers to catch flights or explore the city. With 371 thoughtfully designed rooms, our hotel is strategically positioned close to commercial hubs and key business districts. Work seamlessly in our smart meeting rooms, relax in comfortable rooms, or connect with like-minded people in our vibrant community spaces. Host celebrations in our banquet hall, indulge in all-day dining at Qmin, or unwind at the Sports Bar. For those who like to stay active, our fully equipped fitness center and refreshing views provide the right balance of energy and relaxation. At Ginger Mumbai Airport, every detail is designed to make your stay Simply Better, bringing together modern hospitality, prime location, and unmatched convenience.
Conference Sponsors
Sponsor
Uncategorized
Pharmaceutical Analysis Masterclass (NCP25)
Download Programme PDFThursday, 6th November 2025
| 08:00 |
REGISTRATION
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| 09:00 |
Technical Session 1
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| 09:00 |
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| 09:15 |
Impurity Profiling and Regulatory Considerations for Impurities Saranjit Singh, Professor & Head, NIPER Mohali, Impurities in Drug substance and Drug Products (ICHQ3 A and B), Residual solvents (ICH Q3C), Elemental Impurities (ICH Q3D), Nitrosamine and Mutagenic Impurities (ICH M7), Extractibles and Leachable. |
| 10:45 |
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| 10:55 |
Tea/Coffee Break
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| 11:10 |
Technical Session 2
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| 11:10 |
Challenges in Pharmaceutical Analysis P. Rita Santhakumar, Consultant and Retired -Head– Analytical Development, SUN Pharmaceuticals, India Tools and Techniques (HPLC, GC, LC-MS, GC-MS. ICP MS), Method development and Analytical QbD and Validation (ICH Q2 and Q14), Sample preparation and Matrix effect, Trace level analysis |
| 12:10 |
Q/A - Analytical Challenges P. Rita Santhakumar, Consultant and Retired -Head– Analytical Development, SUN Pharmaceuticals, India |
| 12:20 |
Analytical Method Development through Quality by Design (QbD) P Siva Sankara Reddy, Director – Analytical Research & Development (Global), Simson Pharma Limited, India 
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| 12:50 |
Group Photograph |
| 13:00 |
Lunch |
| 14:00 |
Technical Session 3
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| 14:00 |
Nitrosamine in Pharmaceuticals : Risk assessment and Safety Evaluation Pravin Karmuse, Global Scientific Advisor, Veeprho Group, India In-depth understanding of nitrosamine & NDSRI formation pathways, Regulatory updates and current guidelines on nitrosamine & NDSRI control (EMA, FDA, etc.), Developing and implementing effective risk assessment strategies for nitrosamines & NDSRIs. |
| 15:00 |
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| 15:10 |
Tea/Coffee Break
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| 15:25 |
Technical Session 4
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| 15:25 |
Quality Control Systems for Nitrosamine and NDSRI Impurities Jörg Schlingemann, Director, Global Quality Control Principal Expert, Merck, Germany Development and implementation of Quality Control System for Nitrosamines and NDSRI impurities in Pharmaceutical industry. |
| 16:25 |
Q/A - Quality Systems Jörg Schlingemann, Director, Global Quality Control Principal Expert, Merck, Germany |
| 16:35 |
Nitrosamine and NDSRI Analysis: Challenges & Solutions Shailesh Damale, Product Specialist, LC/MS and Automation Solutions, Agilent Technologies, India The session aims to provide a comprehensive understanding of nitrosamine analysis workflows, low level detection and quantitation to ensure reliable and reproducible results. 
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| 17:05 |
Extractables & Leachables (E&L) Testing in Pharmaceuticals and Medical Devices Pramod Kumar Ragham, Senior Director,Analytical Services Department, Daicel Chiral Technologies India Pvt. Ltd., India Importance of Extractables and Leachables (E&L) studies in ensuring the safety and quality of drug products and medical devices, defining key concepts, outlining strategic study designs and critical considerations, and detailing the current regulatory and guideline landscape along with practical implementation approaches. |
| 17:35 |
End of Day 1
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Friday, 7th November 2025
| 09:00 |
Technical Session 5
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| 09:00 |
Deriving Safe Limits for Nitrosamines Jörg Schlingemann, Director, Global Quality Control Principal Expert, Merck, Germany |
| 09:45 |
Q/A - Nitrosamine Limits Jörg Schlingemann, Director, Global Quality Control Principal Expert, Merck, Germany |
| 09:55 |
Tea/Coffee Break
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| 10:10 |
TECHNICAL SESSION 6
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| 10:10 |
Analytical Considerations for Extractables & Leachable Thippani Ramesh, Managing Director & CEO, DRHP Testing Solutions, India Analytical strategies for identifying and quantifying extractables from packaging and manufacturing components,Techniques for analysing leachable in drug products (GC-MS, LC-MS, ICP-MS), Method development and validation specificto E&L studies, Correlation of E&L data with toxicological risk assessment & Case studies. |
| 11:10 |
Q/A for Extractable and Leachable Thippani Ramesh, Managing Director & CEO, DRHP Testing Solutions, India |
| 11:20 |
Cutting-Edge UFMS Approaches for NSA, NDSRIs, and E&L in Pharmaceuticals using GCMSMS & LCMSMS Dheeraj Handique, Manager – GC/GCMS Product Marketing, Shimadzu India Pvt. Ltd., Mumbai, India 
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| 11:50 |
Stability Studies and Shelf-Life Determination Saranjit Singh, Professor & Head, NIPER Mohali, Stress studies, Degradation Pathways and stability indicating methods, designing stability studies for drug substances anddrug products (ICH Q1 A and B), Accelerated Stability Assessment Program, Forced Degradation studies. |
| 12:50 |
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| 13:00 |
Lunch Break
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| 14:00 |
Technical Session 7
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| 14:00 |
Handling OOS/OOT Results Shital Pathak, Senior Vice President-Head Analytical R&D, Glenmark Pharmaceuticals, India Handling out-of-specification (OOS) and out-of-trend (OOT) results, Case Studies, Handling of regulatory queries. |
| 15:00 |
Q/A - OOS/OOT Results Shital Pathak, Senior Vice President-Head Analytical R&D, Glenmark Pharmaceuticals, India |
| 15:10 |
Tea/Coffee Break
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| 15:25 |
Technical Session 8
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| 15:25 |
Regulatory Expectations for Impurities and Stability Data in Pharmaceutical Submissions Nirav Chokshi, Executive Director, ISAZI Group of Companies, India Regulatory requirements for impurity characterization, qualification, and control in drug applications (ANDA, NDA), Expectations for stability data and shelf-life justification in regulatory dossiers, Strategies for presenting analytical and stability data effectively to regulatory authorities, Addressing common regulatory queries related to impurities and stability, Best practices for ensuring data integrity and compliance with global regulatory standards, Preparing for and managing regulatory inspections related to analytical and quality functions. |
| 16:25 |
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| 16:35 |
Panel Discussion: Navigating Complexities in Pharmaceutical Analysis and Quality Saranjit Singh, Professor & Head, NIPER Mohali, Moderator- Saranjit Singh |
| 17:10 |
End of Masterclass
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