Ensuring Integrity of Drug Formulation from Development to QC

Event Overview:

After a small molecule has been identified as a viable drug candidate, substantial testing is required to assure that chemical and structural integrity are preserved throughout the drug development process to maintain its functionality. To keep a balance between quality and manufacturability, time-consuming and labor-intensive testing and analysis are required to demonstrate that chemical integrity is intact. Among the techniques used to study changes in chemical integrity are infrared and Raman spectroscopy.

 

This webcast will discuss where efficiencies can be made in data collection, regulatory compliance, instrument qualification, method validation, and data integrity all along the development pipeline up to final quality control (QC) testing. Learn how to quickly identify changes in polymorphic structure, monitor API to excipient distribution, and troubleshoot out-of-specification (OOS) product lots, while preserving data integrity needed for audits.

Key Learning Objectives:

  • Where along the drug development path can FTIR, NIR and Raman techniques be used and what knowledge is gained
  • How to minimize the number of laborious steps in analytical method validation, verification, and transfer to QC and manufacturing
  • What to look for in a hardware-software platform to not only assure drug formulation integrity but also data integrity

Who Should Attend:

  • Analytical support scientists
  • R&D chemists
  • Manufacturing engineers
  • QC technicians and managers
  • Pharmaceutical scientists

For registration click here: REGISTER

Michael Bradley, Ph.D
Michael Bradley, Ph.D
Senior Manager, Global Training
Thermo Fisher Scientific

Dr. Michael Bradley taught graduate and undergraduate chemistry for 15 years, prior to becoming a field applications scientist with Thermo Nicolet™ – subsequently Thermo Fisher Scientific™. He worked with teams to develop and launch the Thermo Scientific Nicolet iN™10 FTIR Microscope and Nicolet iS™10 FTIR spectrometers. He then led the development of the Thermo Scientific Nicolet iS50 FT-IR spectrometer. He is now Senior Manager, Global Training with roles in FT-IR and Raman training and product development, mainly helping customers better utilize the spectroscopy tools and ensuring customer feedback reaches into next generation tools. He also sits on the Advisory Board for Spectroscopy Magazine.

Katherine Paulsen
Katherine Paulsen
Product Manager – Routine Spectroscopy
Thermo Fisher Scientific

Katherine Paulsen is a member of the routine spectroscopy team responsible for developing new spectroscopy products for a variety of end markets, including pharmaceuticals, polymers, and academic teaching institutions. The group focuses on small form factor, laboratory FTIR spectrometers that are used to conduct routine analysis in QA/QC environments. Katherine joined the Thermo Fisher Scientific in 2013. During her time with the company Katherine has worked as a member of the commercial sales team, the service organization and now product management. Katherine holds a Ph.D. in Chemistry from the University of Wisconsin-Madison.

Mike Garry
Mike Garry
Sr. Product Manager – NIR Spectroscopy
Thermo Fisher Scientific

In his thirty year career with Thermo Fisher Scientific, Mike Garry has filled many technical and management roles involving FTIR technology. He led product development and marketing efforts for routine FTIR analyzers, software and applications used in a wide variety of industrial QC applications. Mike has a strong background in meeting the regulatory compliance needs of the pharmaceutical industry. He was instrumental in the implementation of instrument qualification packages and 21 CFR Part 11 data security tools. In his current role as Senior Product Manager for Industrial FT-NIR products, he leads a team developing and marketing spectroscopy products used for routine analysis in laboratory and on-line industrial production environments.

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