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Pharmaceutical Technology

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2012 Speakers & Presentations

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EXCIPIENTFEST - Educational Sessions

Visit IPEC's website for Online Presentations


DAY 1 - Tuesday, April 24th  Theme: Corporate Responsibility: Supplier Selection and Supply Chain Security

KEY-NOTE SPEAKER: “Corporate Responsibility” Michael Beatrice - Abbott (IPEC)

Quality Risk Management - Excipient Perspective” Ms. Londa Ritchey - Pfizer (IPEC)
“Excipient News for Novel Formulations” Mr. Stephen Levine – Emerson Resources
 
“The method of fine dissolution control of tablets by direct compression in different test media using novel pregelatinized starch” Ms. Yurika Tanaka – Asahi Kasei
“What does it mean to have an IPEA Certification? (International Pharmaceutical Excipient Audit)” Mr. Irwin Silverstein – IPEA (IPEC)
 
“cGMP Enforcement for the Pharmaceutical Industry” Mr. Edwin Ramos - FDA SJDO Compliance Director (IPEC)
“Meeting Formulation Challenges for Poorly Soluble Drugs” Mr. Nigel Langley – BASF
 

Lunch

“Up-Stream Supply, Chain Security for Excipients through Distribution” Ms. Griselle Vargas - Mutchler Inc.
“Excipact Update on Excipients” Mr. Koen Bontinck – NSF International (IPEC)
 
“Supplier Management, Assuring a Secure Supply Chain” Louis Yu - Perrigo (IPEC)
“Application Studies of L-HPC and HPMCAS for Pharmaceutical Solid Dosage forms - An Update” Mr. Sakae Obara – Shin-Etsu
 

SPEAKERS’ ROUND TABLE:
“IPEC's Atypical Visible Particles Guideline” (Moderated by Pharmaceutical Technology)
Speakers from FDA - Ms. Cindy Buhse, Pfizer - Ms.Janeen Skutnik, DowWolff Cellulosics - Ms. Ann Van Meter and IPEC - Ms. Ruth Kogut

DAY 2 - Wednesday, April 25th Theme: Developments in Excipient Legislation and Regulation

KEY-NOTE SPEAKER: "Future of Excipient Regulation - Revised GMPs and Excipient Expectations" Ms. Maridalia Torres, FDA Director SJDO

“Legislative Update; An Industry Perspective“ Mr. James Willtraut - Buchannon Ingersoll (IPEC)) by Ms. Catherine Sheehan - USP
“Innovative Techniques for Effective Cleaning of Time Release Polymers and Color Coatings” Ms. Kristina Wesley – Dober
 
“USP Monograph Modernization Initiative: Excipient update” Ms. Catherine Sheehan - USP
“Inactive Ingredient Database” Ms. Priscilla Zawislak – Ashland (IPEC)
 

Lunch

“Enhancing Excipient and Raw Material Surveillance through the FDA Spectral Library Initiative” Ms. Cindy Buhse, Director, Div. Pharmaceutical Analysis, CDER, FDA (IPEC)
“Beware of the Non-Critical Excipient in QbD” Mr. Brian Carlin – FMC
 
“Controlled Release the Co-Processed "Whey" Mr. Joseph Zeleznik – Meggle
“NSF Reference Standards for Excipients” Mr.Steven Lane – NSF International (IPEC)
 
“Quality by Design Approach for Determining Excipient Specifications" Mr. Madhu Kallam – Avantor Performance Materials
“Elemental Impurities - Excipient Realities” by David Schoneker, Colorcon (IPEC)
 

KEYNOTE SPEAKER:
“Quality by Design: Understanding Roles of Excipients” Lawrence Yu - FDA (IPEC)

Workshops


Pharmaceutical Formulation on Tablet Dosage Forms - Emerson Resources, Inc.

Overview and Implementation of selected IPEC Guides - IPEC Americas

IPEC QbD Workshop on Excipient Variablitiy: Design and Lifecycle Implications - IPEC Americas.

Excipient Supplier Auditing & Qualification - IPEA Inc.



Click here to see the EF 2012 PHOTO ALBUM