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Pharmaceutical Working Group Members

Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach

 

Contracts Management

Chair, Theresa Mullin, OC, OPPL
Project Manager, Kate McEvoy, OC, OPPL
Helen Winkle, CDER
Ajaz Hussain, CDER
Jim Cohen, CBER
David Horowitz, CDER
Paul Raynes, ORA
Steve Toigo, ORA
Geoffrey Wong, CVM

 

International Activities

Chair, Michelle Limoli, OIP
Project Manager, Sema Hashemi, OC, OIP
Ajaz Hussain, CDER
Doug Ellsworth, ORA
Justina Molzon, CDER
Joan Blair, CBER
Jon Clark, CDER
Edwin Rivera, CDER
Steve Solomon, ORA
Diana Kolaitis, ORA
Merton Smith, CVM
Anita Richardson, CBER
Monica Caphardt, CDER

 

Part 11

Chair, Joe Famulare, CDER
Project Manager, Anne Henig, CDER
Patricia Beers-Block, OC
Dave Doleski, CBER
Jennifer Goldstein, OCC
Dave Elder, ORA
Nicole Mueller, CDER
John Murray, CDRH
George Smith, CDER
Vernon Toelle, CVM
JoAnn Ziyad, CDER
Erik Henrikson, CDER
John Lienesch, OC
Audrey Thomas, CDER
Sion Wyn, Contractor

 

Dispute Resolution

Co-chair, David Horowitz, CDER
Co-chair, Helen Winkle, CDER
Project Manager, Ted Sherwood, CDER
Mary Malarkey, CBER
Jorge Christian, CVM
Mary Leadbetter, CVM
Michael Rogers, ORA
Walt Brown, ORA
Abi D’Sa, CDER
Doug Ellsworth, ORA
Susan Allen, CDER
Anita Richardson, CBER
John Dietrick, CDER

 

Warning Letter Review

Chair, Fred Blumenschein, CDER
Project Manager, Erik Henrikson, CDER
Mary Malarkey, CBER
Bob Sausville, CBER
Gloria Dunnavan, CVM
Diane Kelley, ORA
Tom Chin, ORA

483 Communications (Project Complete)

Co-Chair, Peter Beckerman, OC, OCC
Co-Chair, Debbie Ralston, ORA
Project Manager, Rose Cunningham, CDER
John Taylor, ORA
John Dietrick, CDER
Jim Cohen, CBER
Mary Meyer, CBER
Joanne Binkley, CBER
Gloria Dunnavan, CVM
Michael Rogers, ORA
Anita Richardson, CBER
Reynaldo Rodriguez, ORA

 

Changes without Prior Review

Co-Chair, Ajaz Hussain, CDER
Co-Chair, Jon Clark, CDER
Project Manager, David Cummings, CDER
Chris Joneckis, CBER
John Finkbohner, CBER
Dennis Bensley, CVM
Nancy Rolli, ORA
Patricia Lefler, ORA
Nick Buhay, CDER
Lynn Whipkey, OC, OCC
Andrew Chang, CBER
Charles I. Ahn, ORA

 

Product Specialist on Inspection Teams

Chair, Ajaz Hussain, CDER
Project Manager, Robert King, CDER
Joyce Frey Vasconcells, CBER
Mai Huynh, CVM
Jorge Christian, CVM
Patricia Lefler, ORA
Kip Priesmeyer, ORA
Nick Buhay, CDER
Frank Holcombe, CDER
Jon Clark, CDER
Keith Webber, CDER

 

Risk-Based Site Selection (formed from the Workplanning and Risk Management Group)

Chair, David Horowitz, CDER
Project Manager, Lindsay Cobbs, CDER
Nga Tran, Contractor
Kara Morgan, OC, OPPL
Randy Woods, CDER
Jon Clark, CDER
Gregg Claycamp, CVM
Charles Gray, CVM
Brian Hasselbalch, CDER
Carol Rehkopf, CBER
Vince Zenger, CDER
Villayat Sayeed, CDER
Anna Flynn, CBER
Gerald Feldman, CDER
Diana Kolaitis, ORA
Norman Schmuff, CDER
Rajendra Uppoor, CDER
Tom Arista, ORA
Susan Bernard, OC, OPPL
Elaine Cole, CBER
Chris Watts, CDER

 

Pharmaceutical Inspectorate

Co-Chair, Janet Woodcock, CDER
Co-Chair, Susan Setterberg, ORA
Debbie Ralston, ORA
Mary Leadbetter, CVM
Jorge Christian, CVM
Helen Winkle, CDER
Karen Hirschfield, CDER
Mary Malarkey, CBER
Kara Lynch, ORA
Gary German, ORA
Janice Newcomb, CDER

 

Manufacturing Science

Chair, Ajaz Hussain, CDER
Project Manager, Chris Watts, CDER
Andrew Chang, CBER
Chris Joneckis, CBER
Raafat Fahmy, CVM
Mai Huynh, CVM
William Bargo, CVM
Bob Coleman, ORA
Diana Kolaitis, ORA
Elise Murphy, ORA
Anthony Charity, CDER
Frank Holcombe, CDER
Jon Clark, CDER
John Dietrick, CDER
See Lam, CDER
Vilayat Sayeed, CDER
Norman Schmuff, CDER

 

Process Analytical Technology

Chair, Ajaz Hussain, CDER
Joe Famulare, CDER
Moheb Nasr, CDER
Keith Webber, CDER
Frank Holcombe, CDER
Doug Ellsworth, ORA
Patricia Lefler, ORA
Dennis Bensley, CVM
Chris Watts, CDER
Ali Afanan, CDER
Huiquan Wu, CDER
Raj Uppoor, CDER
John Simmons, CDER
Karen Bernard, CDER
See Lam, CDER
Robert Coleman, ORA
Rebecca Rodrigues, ORA
Erin McCaffery, ORA
George Pyramides, ORA
Dennis Guilfoyle, ORA
Albinus D’Sa, CDER
Mike Gavini, CDER
William Bargo, CDER
Brenda Uratani, CDER
Norman Schmuff, CDER
Lorenzo Rocca, CDER
Vibhakar Shah, CDER
Rosario D’Costa, CDER
Raafat Fahmy, CVM
Brian Riely, CDER

 

Quality Systems Framework

Co-Chair and Project Manager, Lana Pauls, CDER
Co-Chair and Project Manager, Patricia Maroney-Benassi, ORA
Jerome Cordts, OC
Stan Woollen, OC
Janet Woodcock, CDER
Cheryll Wells, CDRH
Katherine Weld, CVM
Michael Smedley, CVM
Sherry Purvis-Wynn, ORA
Leo McNamara, CBER
Deborah Jansen, CBER
Sherry Lard, CBER
Elizabeth Harden, CFSAN
Judith Gushee, CFSAN

 

Good Guidance Practice

Chair, Jane Axelrad, CDER
Project Manager, Susan Cohen, CDER
Nancy Derr, CDER
Brian Hasselbalch, CDER
Jon Clark, CDER
Paula McKeever, CBER
Diane Maloney, CBER
James Cohen, CBER
Anita Richardson, CBER
Charlotte Christin, CFSAN
Lou Brock, CFSAN
Joe Baca, CFSAN
Don Zink, CFSAN
Michael Smedley, CVM
Gloria Dunnavan, CVM
Lana Ogram, ORA
George Smith, CDER
Sally Winthrop, CDER

 

Quality Systems Guidance Development

Co-Chair, Joe Famulare, CDER
Co-Chair, Bob Sausville, CBER
Project Manager, Patrick Guinn, CDER
Monica Caphart, CDER
Chris Joneckis, CBER
Diane Alexander, CBER
June Liang, CVM
Mike Smedley, CDER
Patricia Maroney-Benassi, ORA
Sherry Purvis-Wynn, ORA

 

GMP Harmonization Analysis

Co-Chair, Kim Trautman, CDRH
Co-Chair, Mary Malarkey, CBER
Project Manager, Vikki Kinsey, CDER
Brian Hasselbalch, CDER
Fred Blumenschein, CDER
Diane Alexander, CBER
Dennis Bensley, CVM
Jo Gulley, CVM
Peter Vardon, CFSAN
Karen Strauss, CFSAN
Walt Brown, ORA
Phil Lindeman, ORA
Ann DeMarco, ORA
Patricia Love, OC, Office of Combination Products

 

Evaluation of the Initiative

Co-Chair, Janet Woodcock, CDER
Co-Chair, Theresa Mullin, OC, OPPL
Project Manager, Carolyn Staples, OC, OPPL
Michele Bonhomme, OC, OPPL
Pam List, OC, OPPL,
Andy Sigman, OC, OPPL
John Goldsmith, OC, OPPL