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Short Course

Course Information
Course Title: Methods Development (QbD) With Risk Based Strategy Validation Procedures and Compliance Issues
Categories: 1 - Laboratory Information and Management
2 - Liquid Chromatography
3 - Liquid Chromatography-Mass Spectrometry
4 - Pharmaceutical Sciences
5 - Quality/Regulatory/Compliance
6 - Validation
Instructor(s): Shib Mookherjea Course Number: 38
Affiliation: ValQual International, Inc.
Course Date: 03/05/2016 - Saturday Course Length: 2 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Course Date 2: 03/06/2016 - Sunday    
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $1050 ($1450 after 2/12/16) Textbook Fee:

Course Description
This Short Course offers and outlines a systematic, sequential approach to the Development & Validation activities while emphasizing the rationale of a scientific approach & understanding of the basic elements of Analytical Methods from Quality Systems and Measurement Uncertainty/Total Error perspectives. The organization of these discussions provides the schematics of goal oriented Methods Development within the framework of a very generic, iterative & modular approach to understand validation and will introduce several new concepts, including recognition of the Critical Quality Attributes of the Analytical Method as a measurement process while moving thru Design & Development/Optimization and subsequent activities. It aims at providing a very generic roadmap starting with the Quality aspects and following thru with the various stages, including a Risk based strategy of Design, Development (including Sample Prep.), Optimization and finally arriving at the Pre Validation criteria. Extensive discussions going over the Guidelines from ICH, Q2R(1) and other sources like USP, EP, AOAC and others will be discussed. The presentation builds on data handling, documentation & Regulatory requirements for various stages of Drug Development (IND, NDA, ANDA,,,). Extensive guidance for preparing validation protocols for stages of IND, NDA & laboratory control, QA, QC, statistical tools, SQC, SPC & stability indicating assays will be included. The course is highly interactive & participative.

Target Audience
• Scientists/Managers • R&D Personnel • QA/QC Staff • Validation Coordinators • Quality Assurance Managers • Production and Packaging Personnel • Regulatory/Compliance Managers • Warehouse Managers, Distribution Chain • Qualified Persons (EMEA) • Distributor, Pharmaceutical, Supply, & Purchasing Managers, Shippers

Course Outline
• Quality: QA/QC and Basics of Quality Systems
• Analytical Methods and CQA’s
• Relevance of Data and Data Integrity
• Measurement, Measurement Uncertainty and Error
• Understanding Methods Validation: Basic Approach
• Process Model in Analytical Measurement
• Detection and Quantification
• Relationship of Method vs. Analytical Techniques
• Rationale of Methods of Development and Validation: A Generic Iterative Approach in a Sequential Manner
• Definitions: Validation Parameters
• Basic Statistical Applications (SPC, SQC, etc.)
• Validation Guidelines (AOAC, USP, ICH, WHO, etc.)
• Development of Validation Protocols and Reports
• Analytical Development: Drug Substance, Excipients, Drug Products
• Tables of Data Requirements for Various Products and Applications
• Regulatory Compliance Issues, FDA, WHO, EMEA, EPA and Other Global Guidelines
• Qualification and Validation: Compendial Methods VS newly developed ones
• Drug Development, IND, NDA, ANDA and Requirements of Various Phases for Regulatory Submissions
• Impurities and Degradation Products
• Optimization and Validation in HLPC
• Case Histories, Problem Solving, Group Participation
• Classical and Spectroscopic Methods: Limitations
• Validation of Instruments
• References
• Conclusion

Course Instructor's Biography
Shib Mookherjea, PhD, has a proven track record in analytical problem solving, with extensive accomplishments in the areas of Analytical R&D Management, Pharmaceutical Development, (ICH), Management of QA/QC, Process Upgrade, CpK monitoring, PAT applications, Validation in Methods, Systems, Equipment Qualification. He has guided internal Analytical, Process Development and Quality Teams in various settings. He has held management and supervisory positions within Pharma, Biotech and other companies including Colgate Palmolive, Johnson & Johnson, Troy Corporation, BASF, CRO/CMO Laboratories, Ethicon/Ortho Pharmaceutical and Allergan Medical. Dr. Mookherjea is a highly recognized speaker and has conducted numerous workshops, short courses and seminars in various conferences, expositions and trade shows, in more than 20 countries. He is the Principal of VQI (www.valqualintl.com). He provides global training and consulting in areas of Validation, Methods & Audits for GMP, GLP (FDA/OECD) and ISO 17025, TQM, ISO 9000, Laboratory QA, and Accreditation. He is part of the continuing education faculty of the American Chemical Society, EAS, CFPA and other international training organizations. Dr. Mookherjea has overcome many challenges, which have been successfully met in various corporate settings, by providing the needed training and guidance, utilizing a worldwide network of scientific professionals. He remains an excellent source of reference and assistance in problem solving. Connect with him on LinkedIn at https://www.linkedin.com/pub/shib-mookherjea/25/54a/223