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2010 Speakers & Presentations

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EXCIPIENTFEST - Educational Sessions

Visit IPEC's website for Online Presentations


DAY 1

Preparation of MUPS (Multiple Unit Particles System) Tablets using Celphere and Preliminary Blend of Microcrystalline Cellulose and Pregelatinized Starch, by
Mr. Masayuki Kakizawa - Asahi Kasei
IPEC's Excipient Composition Guideline, by Ms. Priscilla Zawislak - Ashland (IPEC)
 
Magnesium Stearate; Let’s play cards by Mr. Pieter Gommans - Peter Greven
IPEC's New Excipient Evaluation Procedure, by Mr. Christopher DeMerlis -  Colorcon (IPEC)
 
Assuring Supply Chain Security, byMrs.Rosa J. Motta – FDA CDER (IPEC)
IPEC's Excipient Stability Guideline, by Mr. Phil Merrell -  Jost Chemical (IPEC)
 
Excipients for Future – Identification of the Need, Discovery, and the Regulatory Journey to Market, by Dr. Ranga Velagaleti - BASF, Dr. Sherry Ku – Wyeth,  Dr. Harpreet Sandhu  – Hoffmann La Roche
Conforming to the IPEC CoA Guide, by Mr. David Klug - sanofi aventis
 
3rd Party  and Shared Supplier Audits, by Mr. Eric Berg - Amgen & Mr. Irwin Silverstein - IPEA
Co-processing: A Versatile Pathway to Modify Excipients: Lactose Excipients from Fast Disintegrating to Modified Release, by Mr. Franz Penz - Meggle
 
Orally Disintegrating Tablets, by Mr. Joseph Zeleznik -  JRS Pharma
Best Practices for Assuring Supply Chain Security Including Quality Agreements, by Mr. Dale Carter - JM Huber & Alexa Smith - Colorcon (IPEC)
 
Formulation Facilitation of Powder Blends, Sugar-Free Film Coatings and HME with a unique Polyol, by Mr. Bodo Fritzsching - Beneo Palatinit
Quality by Design and Formulation Development, by Mr. Bill Busch - Dow Chemical (IPEC)
 


DAY 2

Commercially available options for BCS Class II, III & IV compounds in all Dosage Forms, by John Giannone – Cognis
The Future of Co-Processed Excipients, by Mr. Brian Carlin, PhD  -  FMC BioPolymers USA (IPEC)
 
New Tests for Identifying Harmful and Potentially Deadly Adulterants in Pharmaceutical Ingredients: The Role of USP NF in Setting Revised Standards, by Ms. Catherine Sheehan - USP
Change Control in Excipient Manufacturing – The Importance in a Quality by Design World, by Mr. Dave Schoneker - Colorcon (IPEC)
 
Bringing Added Value to the Excipient Supply Chain, , by Ms. Elizabeth Plaza – PharmaBioServ & Mr. Dwight Mutchler - Mutchler Inc. PR
Regulation & QA of Excipients in the Nutraceutical/Dietary Supplement Industry: Importance of Ingredient Supplier Qualification, by Mr. Ed Wyszumiala - NSF & Dr. Andrew Shao - CRN (IPEC)
 
Excipient DMF's in China, by Mr. Sun Huimin - Chinese National Institute of Control of Pharmaceutical & Biological Products  (IPEC)
Solubility Enhancement with Methacrylates, by Dr. Abhishek Kathuria - Evonik Polymers
 
FDA - PR Investigator’s Perspective on Review of Supplier Qualification Programs during Audits, by Mr. José Meléndez- FDA PR
Excipient GMPs and The Global Certification Project, by Mr. Dale Carter - JM Huber (IPEC)
 

Speakers' Round Table
Leveling the Playing Field for Excipients

Moderated by Angie Drakulich
Editor of Phamaceutical Technology.

Invited participants Speakers:

Rosa Motta (FDA), Eric Berg of AMGEN and Rx-360; USP’s Catherine Sheehan, BASF’s Ranga Velagaleti and Sherry Ku, CSO of Anchen Pharmaceuticals,  Janeen Skutnik of IPEC and Pfizer, and Dale Carter of IPEC and Huber Engineered Materials.

Workshops


Design of Experiments (DoE) as a Tool for Pharma Manufacturing, Tech Transfer & Troubleshooting - Emerson Resources, Inc.

Film Coating Technology for Pharmaceutical Applications - Colorcon Inc.

Pharma Formulation Workshop for Tablet Dosage Forms - Emerson Resources, Inc.

The Role of Supplier Audit in Supplier Qualification, Supply Chain Security, and Incoming Ingredient Approval - IPEA Inc.
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EF 2010 PHOTO ALBUM