PDA seminar on
Process Analytical Technology (PAT)
and FDA Directives

by Dr. Shib Mookherjea, USA
27 December 2012
Kfar Macabbiah, Ramat Gan

Key Topics

  • Quality Movement and Innovations
  • “Quality by Design” – Paradigm Shift
  • FDA’s Published Directives and Initiatives
  • Risk Assessment Approach (ICH Q8, Q9, ISO)
  • Processing, Understanding, and Monitoring: Process Validation
  • Qualification of Equipment in Laboratories and Production (IQ/OQ/PQ)
  • Real Time Release Testing (RTRT) : Implementation
  • Statistical Tools, Multivariate Analysis
  • Matrixing and Design of Experiments (DOE)
  • Novel Measurement Applications, Devices and Tools: The Microprocessors, Data Loggers
  • Micro Analytical Techniques, Tools & Applications
  • Recent Developments and Training Initiatives

General Information & Course Outline

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 to the framework of PAT implementation. Guidance from recent ICH Guidelines (ICH Q8, Q9, Q10, etc.) and other sources is included.

Discussion will include, with examples, the various analytical techniques including NIR, Raman, Acoustics, GC and 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 various statistical tools, SQC, SPC and DOE, that have applications in PAT will be covered as well.

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.


  • Increase your knowledge of the recent initiatives and directives from US FDA.
  • Become Acquainted with the Impact of Automation and Innovation on Production, Processing and Quality Assurance of Pharma Initiatives.
  • Familiarize yourself with the Process Model in Global Quality Standards.
  • Learn about Micro Analytical Techniques, Tools, and Applications; specifically examples from NIR, Raman, Acoustics, GC, and other techniques.
  • Increase your knowledge of examples of product testing and release


  • 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 o of ICH guidelines , in Pharmaceutical development
  • Acknowledgements
  • References & Bibliography

Who Should Attend

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

About the Speaker

Dr. Shib Mookherjea

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). The diversity of experience in various settings have included leading teams in R&D, QC providing developmental and ongoing support for dosage forms, in process materials, excipients, generic drugs, biotech products, MaBs , Medical Devices, etc. He has held positions of increasing responsibilities starting as an analytical scientist and management positions within Pharma, Biotech/Device industries with companies like BASF, Colgate Palmolive, Johnson & Johnson, Troy Corporation, CRO/CMO Laboratories and most recently as a Senior Manager of Analytical Development for Allergan located in California. Dr. Mookherjea is a highly-recognized speaker in domestic US and international forums and is the Principal of Validation Quality International I, (www.valqualintl.com) based in California, USA.


Participation fees:
PDA members - 1600 NIS
Non members - 1800 NIS

Registration is mandatory, please register here

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