IPEC-Americas Standing Committees, Subcommittees & Technical Working Groups

IPEC-Americas organizational chart

2012 meeting schedule

Compendial Review/Harmonization:

Chair: Priscilla Zawislak
Manager, Regulatory Affairs
Ashland Aqualon Functional Ingredients
Ashland, Inc.

Vice Chair: Sherri Main
Analytical Services Team Leader
Roquette America

Working Groups

CMC Sodium
Carboxymethylcellulose/Carmellose
Crospovidone
Ethylcellulose
Gelatin
Glycerine/Sorbitol Solutions/Propylene Glycol
Heavy Metals
Hydroxyethylcellulose
Hydroxypropylcellulose
Methyl Cellulose
Polyethylene Glycol
Propylene Glycol
Residual Solvents
Silicone Dioxide
Starches
Titanium Dioxide

Good Manufacturing Practices

Chair: M. Ann Van Meter (2011)
Senior Quality Systems Specialist
Dow Wolff Cellulosics

Vice Chair:

Working Groups

Excipient Stability - Equipment Qualification
Good Distribution Practices
Supplier Auditing
Validation of Manufacturing Process, Analytical Methods and Cleaning

Membership

Chair: Harry Jeffreys
VP QMS and Compliance
Catalent Pharma Solutions

Safety

Chair: Christopher DeMerlis
Regulatory Affairs Manager
Colorcon

Vice Chair: Brian Xu
Principal Toxicologist
ISP

Regulatory Affairs

Chair: Teresa Chan
Senior Regulatory Specialist
CP Kelco

Vice Chair: Katherine Ulman
Associate Scientist & Global Regulatory Compliance Manager
Dow Corning Corporation

Working Groups

New Excipient Evaluation Procedure
Dietary Ingredients

Excipient Qualification

Chair: Juanita Garofalo
Director, Regulatory Affairs
Avantor Performance Materials, Inc

Vice Chair:

Working Groups

Excipient Information Package Template
Excipient Pedigree
Excipient Qualification
Significant Change
Quality Agreements

Quality by Design (QbD) Product Development

Chair: Brian Carlin, Ph.D.
Director, Open Innovation
FMC BioPolymer

Vice Chair: Frank Murphy
Senior Product Regulatory Specialist
Dow Chemical Company

Working Group

Excipient Composition

USP Liaison

Designated Representative:David R. Schoneker
Director, Global Regulatory Affairs
Colorcon

FDA Relations

R. Christian Moreton, Ph.D.
Principal, FinnBrit Consulting

Product Quality Research Institute Liaison

David R. Schoneker
Director, Global Regulatory Affairs
Colorcon