Course Information
Course Title: Development & Validation of Analytical Methods
Categories: 1 - Pharmaceutical Sciences
2 - Quality/Regulatory/Compliance
3 - Regulatory Compliance
4 - Validation
5 - Laboratory Information and Management
Instructor(s): Shib Mookherjea Course Number: 41
Affiliation: ValQual International Inc
Course Date: 03/01/2010 Course Length: 2 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Course Date 2: 03/02/2010    
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $850 ($1250 after 2/1/10) Textbook Fee:

Course Description
This course is designed with a fundamental grass roots approach to understanding measurement uncertainty and approaches validation in a very generic style. The presentation aims at developing concepts about Methods Validation with a fundamental scientific approach, as well as understanding basic elements of an analytical method both from the Quality Systems perspectives and with the more fundamental approach of measurement, errors and uncertainties in the analytical measurement process in particular. A goal-oriented method development will be introduced with a generic, iterative and modular approach to understand validation in general at the same time establishing the capabilities of the analytical method as the method is being developed. The various stages of scoping out the method initially followed by an informed strategy of design, development and optimization to arrive at the validation parameters will be presented elaborately and lucidly. The guidances from USP, ICH, AOAC and other international standards will be discussed. This very structured presentation continually builds on data handling, documentation and regulatory requirements for regulatory compliance issues. There is extensive guidance provided during the course for preparing validation protocols for various stages of IND, NDA and laboratory control, QA, QC inside companies. A brief discussion on statistical tools, SQC, SPC and stability indicating assays are included. Group exercise and case studies with real examples are integral parts of the presentation. This course is highly interactive and participative. Attendees are encouraged to participate throughout the entire presentation.

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 Errors
• 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
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.