Pharmaceutical Analysis Webinars with Spectroscopy, Extrusion, and XRD

The ever-changing regulatory environment faced by manufacturers in pharmaceuticals and other regulated industries can cause confusion and doubts about compliance. Instrument systems designed to meet regulatory requirements can relieve the burden for manufacturers. How do they do it?

Watch this webinar to see how two different instrument platforms – FTIR and Microvolume UV-Vis – help labs assure compliance in their processes.

During this webinar, you’ll learn:

• How 21 CFR Part 11 is managed with innovative software controls
• The simplified workflows to create and deploy SOPs
• Why ongoing performance verification tests can give you peace of mind

The Thermo Scientific Nicolet Summit PRO FTIR Spectrometer (for raw and finished material QA/QC) and the Thermo Scientific NanoDrop One Spectrophotometer (for DNA, RNA, and protein quantification) provide confidence when approaching your next audit.

Key Learning Objectives:

• How to enable 21 CFR Part 11 in the lab
• How to use workflows to ensure compliance from each analyst
• How to leverage built-in performance tests to consistently check instruments are fit for purpose

Who Should Attend: Lab managers in regulated environments (pharma, biopharma)

Run Time:43 minutes

The distribution of API in a pharmaceutical tablet is a critical factor in developing drugs that are effective when consumed. What’s the best way to figure that out?

The combination of FTIR and Raman spectroscopy with mapping is well-suited for identifying and sizing API domains. Both techniques provide excellent chemical and spatial information about the distribution and concentration of the API in a tablet.

Key Learning Objectives:

• How to collect area data in FTIR and Raman imaging
• How to process and analyze a large mapping/imaging data set
• Understand and interpret the data to communicate to stakeholders

Who Should Attend:

• Lab managers
• Technical instrument operators
• Graduate students

Run Time: 1 hour

Reducing costs and improving efficiency have always been a goal, but these needs are increasingly critical for pharmaceutical companies in the current pandemic era. Near-infrared (NIR) spectroscopy is a non-destructive analytical tool that provides solutions from drug development to the QA/QC lab, and in at-line, on-line, or continuous manufacturing processes. Its potential in the pharmaceutical manufacturing value chain is still expanding.

This webinar will highlight NIR’s incredible capabilities across a variety of drug forms, in regulatory compliance, for GMP environments, and more.

Key Learning Objectives:

• NIR spectroscopy as an alternative to wet chemistry and HPLC/GC method with the same accuracy but faster, cheaper, and non-destructively
• What to look for in a hardware-software platform to assure drug formulation integrity as well as data integrity
• Considerations for integrating NIR technology into the analytical workflow within pharma

Who Should Attend:

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

Run Time: 47 minutes

Injectable implants offer several advantages as drug delivery systems including site-specific release and high patient compliance. Hot melt extrusion (HME) is an ideal method for the manufacture of such implants because it can be scalable from early R&D to commercial manufacturing (often with a single instrument). It can also be done in a continuous manufacturing environment. Watch this webinar for an overview of implant types, materials, and scale-up from development to full-scale manufacturing.

Key Learning Objectives:

• Understand implant types and key applications
• Learn how HME is used to produce injectable implants
• See how instruments can be setup from R&D through commercial manufacturing

Who Should Attend: Scientists and engineers in the pharmaceutical industry who deal with development and production of drugs and medical devices

Run Time:36 minutes

X-Ray diffraction (XRD) offers valuable analytics in pharmaceuticals both for research – providing a crystalline “fingerprint” for impurities, patents, etc. – as well as for quality control in manufacturing – parameter optimization, batch identity, etc. Its non-destructive nature and relatively easy sample preparation benefit all users.

Yet any analysis is dependent on capable sample preparation and the ability to acquire reliable measurements. Add in the regulatory compliance required for pharmaceutical companies, and it means the XRD workflow truly has to function smoothly and consistently to get successful results.

This webinar will show you guidelines not only for sample preparation but also different measurement strategies while complying with even the most recent regulatory requirements.

Key Learning Objectives:

• How sample preparation and measurement strategies such as texture reduction in transmission can influence your results
• How a state-of-the-art software solution handles polymorphism and enhances your XRD analysis
• About auditing trails and what you can expect from proven compliance software solutions

Who Should Attend:

• QA/QC lab managers and scientists
• R&D scientists
• Formulation and crystallization scientists

Run Time: 54 minutes