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Short Course

Course Information
Course Title: Methods Development and Validation with a Scientific Approach and Risk Based Strategy
Categories: 1 - Liquid Chromatography-Mass Spectrometry
2 - Pharmaceutical Sciences
3 - Data Management
4 - Quality/Regulatory/Compliance
5 - Validation
6 - Laboratory Information and Management
Instructor(s): Shib Mookherjea Course Number: 64
Affiliation: ValQual International, Inc.
Course Date: 03/04/2017 - Saturday Course Length: 2 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Course Date 2: 03/05/2017 - Sunday    
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $1100 ($1500 after 2/18/17) Textbook Fee:

Course Description
Methods Development & Validation with a scientific approach & understanding basic elements of analytical method from Quality Systems & Measurement, Errors & Uncertainties. Goal-oriented method development (QbD & Risk Based Strategy) with a generic, iterative & modular approach to understanding validation and establish analytical method during development Various stages of the method followed by strategy of design, development & optimization presented. USP, ICH, AOAC guidances discussed. Presentation builds on data handling, documentation & regulatory requirements. Extensive guidance for preparing Validation Protocols depending on stages of IND, NDA submissions & Laboratory control, QA, QC. Statistical tools, SQC, SPC & Stability indicating assays included. 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
• 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
Dr. Shib Mookherjea has a proven track record in analytical problem solving, R&D and extensive accomplishments in the areas of Pharmaceutical Development, (ICH Q6, Q7A, Q8), Management of QA/QC, Process Upgrade, CpK monitoring, PAT applications, Validation in the laboratory (Methods, Systems, Equipment Qualification), and support for dosage forms, in process materials, excipients, DS, DP, medical devices, etc. He has held Management and supervisory positions within Pharma, Biotech and other companies including Colgate Palmolive, Johnson & Johnson, Troy Corporation, BASF & CRO/CMO Laboratories. Dr. Mookherjea is a highly-recognized speaker and 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. He has conducted hundreds of sessions in more than 25 countries, provided training to more than 8000 attendees on various aspects of Validation, Qualification, CAPA, Conduct of GLP Studies over the last 20 plus years. He has presence in LinkedIn and other public media.