What "Significant Change" Means for Excipients

Tuesday, May 15, 2018 - 11:00am

Review of IPEC-Americas most recently updated Significant Change guide.

Learning Objectives

  • The "What" - A uniform approach to significant changes in manufacturing and distribution of excipients
  • The "Whys" - Importance and benefits of a uniform approach to significant change
    • Impact of changes on excipient quality and performance
  • The "Hows" - Understanding and applying the requirements set forth in the 2014 IPEC Significant Change Guide, including
    • A review of the newer parts to the guide and important things that changed in the 2014 version
    • When to use Risk Assessment to assess a change
    • Examples of specific changes and their categorization as "Significant" or "Not Significant"

Presenter(s)

Bretta Lichtenhan

Head of Pharma Registrations - Pharma and Food Materials Life Science
MilliporeSigma

Bretta Lichtenhan is Head of Pharma Registrations within the Regulatory organization of the Life Science division of MilliporeSigma.  She manages a global team of regulatory experts, focused on regulatory registration of products such as excipients, active pharmaceutical ingredients (APIs), highly potent APIs, linkers, antibodies & antibody-drug conjugates, and pharmaceutical materials for the (bio-) pharmaceutical industry. She is currently Vice Chair of Administrative Affairs on IPEC-America’s Executive Committee and has previously chaired the Excipient Qualification Committee.  Bretta has also been actively involved in the planning of ExcipientFest Americas (now Excipient World), for the last several years.  She has over 20 years of experience in the industry with previous experience at Biopharma companies Genzyme (a Sanofi Company) and Percivia LLC.  Bretta has worked for MilliporeSigma for over 9 years in various roles from R&D Product Development, Product Management, Regulatory Affairs and Business Development.  Bretta has a bachelor’s degree in Biology from the University of New Hampshire and Master of Biotechnology Engineering from Tufts University

Heather Sturtevant

Manager, Technical Operations
J&J Consumer Healthcare

Manager within the Technical Operations departing of McNeil Consumer Healthcare focusing on raw materials. She has worked in the Pharmaceutical Industry for 11 years in Process Development, Technical Transfer and Raw Material Evaluation roles. She currently Vice Chairs the IPEC Americas Excipient Qualification Committee.

Cancellation Policy

Note:

Cancellations for live webinars must be made in writing and can be mailed or e-mailed to:

IPEC-Americas Webinars
3138 10th Street N
Arlington, VA 22201
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E-mail: ipecamer@ipecamericas.org

Registration fees are refundable for attendees registered for individual webinars, if cancellation is received at least five (5) business days prior to the course. Notices of cancellation received 0-4 business days prior to the course will not be provided a refund. If you registered and are unable to attend the webinar, a recording of the webinar will be provided.

No cancellations are available for webcasts (archived recorded webinars). Recordings are available for 21 days after purchase.

Questions?
Please contact IPEC-Americas Training Coordinator
571-814-3450 or email ipecamer@ipecamericas.org