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Short Course

Course Information
Course Title: Highlights of Process Analytical Technology (PAT) & FDA Directives
Categories: 1 - Clinical Analysis
2 - Pharmaceutical Sciences
3 - Data Management
4 - Quality/Regulatory/Compliance
5 - Validation
6 - Laboratory Information and Management
Instructor(s): Shib Mookherjea Course Number: 66
Affiliation: ValQual International, Inc.
Course Date: 03/07/2017 - Tuesday Course Length: 1 Day Course
Start Time: 08:30 AM End Time: 05:00 PM
Fee: $575 ($775 after 2/18/17) Textbook Fee:

Course Description
This presentation will introduce some of the recent initiatives and directives from US FDA as well as the genesis, scope, relevance and applications of PAT framework. Some basic understanding of process measurement, process optimization and control, impact of micro sensors and online monitoring tools will be provided. Some examples of micro analytical techniques in process control and validation will be included. The FDA PAT directives and the scope will be discussed with relevance the framework of PAT implementation. Guidance from recent ICH Guidelines (ICH Q8, Q9, Q10, etc.) and other sources are included. Discussion will include, with examples, the various analytical techniques including NIR, Raman, Acoustics, GC, HPLC that are finding more and more applications in At line, On line measurements at various stages of production and processing. In addition, the dynamics of Real Time Release Testing ( RTRT ) as sometimes adopted by companies will be discussed vis a vis the challenges in implementation. The applications of various statistical tools, SQC, SPC and DOE, have various applications in PAT and will be covered. The management of PAT initiatives and applications inside companies remains a challenge, and the discussions will include the dynamics related to such activities, with an eye on future developments.

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
•Introduction: The Quality Movement & Innovations
•"Quality by Design" – Paradigm Change
•Impact of Automation & Innovation on Production, Processing & Quality Assurance of Pharma Initiatives
•FDA's New Millennium Initiatives
•The Process Model in Global Quality Standards
•Recent Initiatives & Directives on PAT
• PAT Framework
• Background & Scope of PAT
• Focus of PAT: Some Nomenclature
• Potential Applications
•Risk Assessment & Analysis: Novel Approach
•Process Understanding: Measurement, Design & Optimization
•Statistical Tools & Process Capabilities: Basic Applications
•SQC, SPC and Process Monitoring : Multivariate Analysis
•Novel Measurement Tools, Devices & Applications
•Micro Analytical Techniques, Tools & Applications
• Examples from NIR, Raman, OLCR and Other Techniques
• Monitors, Interfaces & Micro Sensors : The NeSSI Platform
• Micro Reactors Developments and Some Examples
• Solid Dosage Forms Applications & Examples
• Acoustic Applications & Examples
• Spectroscopic Techniques
•Further Developments in applications , other PAT tools.
•CPAC And Academic Sites : Recent Activities
•Summary of Guidelines :Regulatory Perspectives
•Other Sources & References From FDA
•Integration of ICH guidelines , in Pharmaceutical development
•Acknowledgements
•References & Bibliography

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.