FDAnews Announces — On-the-Line Process Analytics: Expert Details How to Get Started, What to Avoid Webinar, July 7, 2015

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

On-the-Line Process Analytics:
Expert Details How to Get Started, What to Avoid
**FDAnews Webinar**
July 7, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/onthelineprocessanalytics

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 manufacturers purchase the right equipment and properly integrate it into their 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 attendees 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 manufacturers best position themselves to not get left behind?

In 90 minutes attendees will learn:

  •     The difference between internal and external validation
  •     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:

o    Validation of statistical functions
o    Maintenance of data storage and transfer methods
o    Development (and re-development)
o    Selection and preparation of samples
o    Calibration, optimization and assessment

Don’t fall behind technologically or waste money on outdated paradigms.

Meet the Presenter:
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.

Who Will Benefit:

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

Conference Details:
On-the-Line Process Analytics:
Expert Details How to Get Started, What to Avoid
**FDAnews Webinar**
July 7, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/onthelineprocessanalytics
Tuition: $287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/onthelineprocessanalytics
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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