Making the Grade: The Importance of Using the Correct Excipient Grade in Drug Products

Gain a greater understanding about OSD manufacturing and how advances in continuous processes are shaping the sector.

Register Free: https://www.pharmtech.com/pt_w/correct-excipient-grade

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
• Pharma Solutions
• Coating 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

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

Register Free: https://www.pharmtech.com/pt_w/correct-excipient-grade