On-The-Line Process Analytics - Webinar CD/Transcript

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On-The-Line Process Analytics: Expert Details How to Get Started, What to Avoid

Traditional analytics in pharmaceutical manufacturing are time-consuming and of limited value. Samples must be taken off the line, sent to a separate lab for testing, and by the time the results come back, it may already be too late to address any problems found, save by throwing out the entire batch – a massive waste of time and money.

Process analytics, on the other hand, gather massive amounts of data in real-time from on the line itself, streamlining the entire process and making it far likelier to address issues in a timely manner.

They are superior in every way. So how can you purchase the right equipment and properly integrate it into your manufacturing program? Without a drastic overhaul of the whole structure and cGMP compliance concerns?

Paul Mason, an industry veteran in numerous aspects of chemical analysis and validation, will take you through the benefits and pitfalls of various types of process analytics.

Particular attention will be given to near-infrared (Near-IR) spectrometry, the first type recently given guidance for by FDA. What does this guidance suggest about how they will treat process analytics going forward? How can you best position yourself to not get left behind?

In 90 minutes you’ll learn:

  • The difference between internal and external validation – and why you need both
  • 2 different methods for internal validation and 5 considerations for external validation
  • How FDA’s guidance suggests a shift to a “life-cycle” approach
  • The 4 modes for operation of Near-IR (off-line, at-line, on-line, in-line)
  • 3 models of chemometric data analysis and when to use them
  • Best practices for meeting regulatory guidance and effectively deploying lifecycle management, including:
    • Validation of statistical functions
    • Maintenance of data storage and transfer methods
    • Development (and re-development)
    • Selection and preparation of samples
    • Calibration, optimization and assessment

Don’t fall behind technologically or waste money on outdated paradigms.

This course will be of benefit:

  • Data management and statistics personnel
  • Engineering and design controls teams
  • Executive management
  • QA/QC personnel
  • Validation specialists/scientist/engineers

Paul Mason, Ph.D. has over 17 years’ experience in chemical analytics and validation for manufacturing. He is Director of Science and Technology Practice at Lachman Consultant Services. He previously held the positions of Associate Director of Quality Control Chemistry at Gilead Sciences; Director of Analytical Research and Development at Coldstream Laboratories; Section Head of Analytical Development and Quality Control at Albany Molecular Research Inc. (AMRI); and Technical Development Chemist / Senior Analyst at Exchem Organics.