Educational Sessions DAY 1 - Wednesday, May 5th

Preparation of MUPS (Multiple Unit Particles System) Tablets using Celphere and Preliminary Blend of Microcrystalline Cellulose and Pregelatinized Starch
Mr. Masayuki Kakizawa - Asahi Kasei

IPEC's Excipient Composition Guideline
Ms. Priscilla Zawislak - Ashland (IPEC)

Magnesium Stearate; Let’s play cards
Mr. Pieter Gommans - Peter Greven

IPEC's New Excipient Evaluation Procedure
Mr. Christopher DeMerlis - Colorcon (IPEC)

Assuring Supply Chain Security
Mrs.Rosa J. Motta – FDA CDER (IPEC)

IPEC's Excipient Stability Guideline
Mr. Phil Merrell - Jost Chemical (IPEC)

Excipients for Future – Identification of the Need, Discovery, and the Regulatory Journey to Market - Dr. Sherry Ku - Wyeth

Dr. Ranga Velagaleti - BASF
Dr. Harpreet Sandhu – Hoffmann La Roche

Conforming to the IPEC CoA Guide
Mr. David Klug - sanofi aventis (IPEC)

3rd Party and Shared Supplier Audits
Mr. Eric Berg - Amgen
Dr. Irwin Silverstein - IPEA

Co-processing: A Versatile Pathway to Modify Excipients: Lactose Excipients from Fast Disintegrating to Modified Release 
Mr. Franz Penz - Meggle

Orally Disintegrating Tablets
Mr. Joseph Zeleznik - JRS Pharma

Best Practices for Assuring Supply Chain Security Including Quality Agreements
Mr. Dale Carter - JM Huber & Alexa Smith - Colorcon (IPEC)

Formulation Facilitation of Powder Blends, Sugar-Free Film Coatings and HME with a unique Polyol 
Mr. Bodo Fritzsching - Beneo Palatinit

Quality by Design and Formulation Development
Mr. Bill Busch - Dow Chemical (IPEC)

Thursday, May 6th

Commercially available options for BCS Class II, III & IV compounds in all Dosage Forms
John Giannone – Cognis

The Future of Co-Processed Excipients
Mr. Dave Schoneker - Colorcon (IPEC)

New Tests for Identifying Harmful and Potentially Deadly Adulterants in Pharmaceutical Ingredients: The Role of USP NF in Setting Revised Standards

Ms. Catherine Sheehan - USP

Change Control in Excipient Manufacturing – The Importance in a Quality by Design World

Mr. Dave Schoneker - Colorcon (IPEC)

Bringing Added Value to the Excipient Supply Chain
Presentation available by contacting Dwight Mutchler: dwight.mutchler@excipientfest.com

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

Mr. Ed Wyszumiala - NSF

Dr. Andrew Shao - CRN (IPEC)

Excipient DMF's in China
This presentation is not available for distribution per NICBPB policy.

Mr. Sun Huimin - Chinese National Institute of Control of Pharmaceutical & Biological Products (IPEC)

Solubility Enhancement with Methacrylates
Dr. Abhishek Kathuria - Evonik Polymers

FDA - PR Investigator’s Perspective on Review of Supplier Qualification Programs during Audits
Mr. José Meléndez- FDA PR

Excipient GMPs and The Global Certification Project
Mr. Dale Carter - JM Huber (IPEC)