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Making the Grade: The Importance of Using the Correct Excipient Grade in Drug Products
Thu, Jan 25, 2024 11:00 AM EST{LOCAL_TZ}
Event Overview:
In this exclusive Drug Digest video interview, Felicity Thomas, Europe/senior editor,
Pharmaceutical Technology
Group, interviews a panel of experts from IPEC Americas about excipient grades. During the panel session, Nigel Langley, David Schoneker, Kathy Ulman, Priscilla Zawislak, and Joseph Zeleznik go into detail about the various excipient grades and why the use of the correct grade in pharmaceutical products is important; what ‘testing up’ of an excipient grade is and if it is possible to do so for drug products; where the responsibility lies in ensuring the correct grade of excipient is used in the manufacture of a drug product; if it is possible to use non-compendial grade excipients in drugs; excipient grade considerations in academic research; the importance of FRCs in formulation development; and considerations for companies looking to change excipient provider.
Interviews featuring:
Nigel Langley,
David Schoneker,
Kathy Ulman,
Priscilla Zawislak,
Joseph Zeleznik,
This episode of Drug Digest is sponsored by:
Veltek
Catalent
Ligand Captisol
Adare Pharma Solutions
Coatings Place
Key Learning Objectives:
The importance of excipient grade
The variance between excipient grades
Securing the excipient supply chain
Using the correct excipient grade in drug products
Potential for ‘testing up’ excipient grades
Who Should Attend:
CDMOs
Formulation scientists
Manufacturers
Excipient manufacturers
Purchasers and supply chain
QA/QC personnel
R&D personnel
Development scientists
Featured Speakers
Nigel Langley
Chair, IPEC-Americas
IPEC-AmericGlobal Technical Director, Life Sciences, Gaylord Chemical Company LLCas
David Shoneker
Executive Committee Member and QbD/Composition Committee Chair, IPEC-Americas
President/Owner, Black Diamond Regulatory Consulting, LLC
Katherine Ulman
Member/Consultant for IPEC-Americas
Owner and Primary for KLU Consulting, LLC
Joseph Zeleznik
Chair-Elect, IPEC-Americas
Technical Director, North America IMCD
Priscilla Zawislak
Vice Chair, Science and Regulatory Policy, IPEC-Americas
Global Regulatory Affairs Advocacy Manager, IFF
Priscilla
has over 35 years’ experience in Regulatory Affairs and Quality for excipients, food additives and ingredients for personal care products. Currently with IFF, she is responsible for regulatory advocacy for excipients, APIs, and food additives. Prior positions include Global Regulatory Affairs Manager for Ashland Specialty Ingredients’ Pharmaceutical and Nutrition business and Quality Manager at FMC Health and Nutrition.
Priscilla is currently President of the IPEC Federation, a global organization consisting of regional IPECs in the US, Europe, China, Japan, and India. She is also the Vice Chair of Science and Regulatory Policy for IPEC-Americas and is also a past Chair of the organization. She has been an active member of IPEC-Americas committees since 2001, is a member of the IPEC Americas Executive Committee and a member of the Board of Directors of EXCiPACT®.
Priscilla earned her degrees in Biological Sciences and Chemistry from the University of Delaware.
For any technical questions please contact Jorge de la Bandera:
JdelaBandera@mjhlifesciences.com
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