2009 PDA/FDA Joint Regulatory Conference

Rabia Ballica, PhD

Tue, 01 Sep 2009 16:17:43 GMT

Rabia Ballica, PhD, CMC/Product Reviewer, CBER, FDA

Dennis M. Bensley, Jr., PhD

Tue, 01 Sep 2009 16:22:37 GMT

Dennis M. Bensley, Jr., PhD, Director, Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, CVM, FDA

Eric Berg

Tue, 01 Sep 2009 16:27:54 GMT

Eric Berg, Director of Supplier Quality, Amgen, Inc.

Michael W. Bonney

Fri, 22 May 2009 10:13:30 GMT

Michael W. Bonney, President and CEO, Cubist Pharmaceuticals, Inc.

Jon Clark

Tue, 01 Sep 2009 16:20:39 GMT
Jon Clark, Associate Director For Policy, CDER, FDA

Howard Drake

Tue, 01 Sep 2009 16:00:04 GMT
Howard Drake, Vice President, Ompi of America

Katherine Eban

Fri, 10 Jul 2009 10:04:41 GMT
Katherine Eban Investigative Journalist and Author

John Eltermann

Tue, 01 Sep 2009 16:19:10 GMT
John Eltermann, Director, Division of manufacturing and Product Quality, CBER, FDA

Joseph C. Famulare

Fri, 22 May 2009 13:11:53 GMT
Joseph C. Famulare, Deputy Director, Office of Compliance, Center for Drug Evaluation and Research, FDA

Thomas Friedli, PhD

Fri, 22 May 2009 13:06:33 GMT
Thomas Friedli, Managing Director Tectem, University of St. Gallen, Switzerland

Rick Friedman

Fri, 22 May 2009 13:00:32 GMT
Rick Friedman, Director, Division of Manufacturing and Product Quality, CDER, FDA

Betsy Fritschel

Tue, 01 Sep 2009 16:15:51 GMT
Betsy Fritschel, Director, Corporate Quality and Compliance Worldwide, Johnson & Johnson

Nigel Hamilton

Wed, 27 May 2009 10:00:45 GMT
Nigel Hamilton, Quality Director, Sanofi Aventis

Lothar Hartmann, PhD

Fri, 10 Jul 2009 10:07:02 GMT
Lothar Hartmann, PhD Head of External Relations - Global Quality, Hoffmann-La Roche

Brian Hasselbalch

Fri, 22 May 2009 12:52:17 GMT
Brian Hasselbalch,Team Leader, Guidance and Policy Team, FDA/CDER/Office of Compliance

Christian Helbig

Tue, 01 Sep 2009 16:14:08 GMT
Christian Helbig, Manager Business Development, SCHOTT North America Inc.

Malcolm Holmes

Fri, 10 Jul 2009 10:09:10 GMT
Malcolm Holmes Retired [previously director Quality Assurance GSK (Glaxosmithkline)]

Kirk Huber

Fri, 10 Jul 2009 10:11:11 GMT
Kirk Huber Executive Director and Global Head of Laboratory and Preclinical Quality Assurance, Novartis Pharmaceutical Corporation

Brian Johnson

Fri, 10 Jul 2009 10:19:15 GMT
Brian Johnson, Director/Team Leader of Contract Operations Quality Assurance, Pfizer Global Manufacturing

Christopher Joneckis, PhD

Tue, 01 Sep 2009 16:12:31 GMT
Christopher Joneckis, PhD, Senior Advisor for CMC Issues, Office of the Center Director CBER, FDA

Shane D. Killian, M.S.

Tue, 01 Sep 2009 16:10:54 GMT
Shane D. Killian, M.S., Manager, Johnson & Johnson Pharmaceutical Supply

Duncan Low, PhD

Tue, 01 Sep 2009 16:09:04 GMT
Duncan Low, PhD, Scientific Executive Director, Amgen, Inc.

Anthony Luttrell

Tue, 01 Sep 2009 16:06:12 GMT
Anthony Luttrell, President, Raland Technologies, LLC

Mary Anne Malarkey

Tue, 01 Sep 2009 16:04:47 GMT
Mary Anne Malarkey, Director, Office of Compliance and Biologics Quality, CBER, FDA

Sei-ichi Manabe

Fri, 10 Jul 2009 10:22:34 GMT
Sei-ichi Manabe President, Sepa-Sigma, Inc.

Daniel G. McChesney, M.S., PhD

Wed, 03 Jun 2009 16:54:58 GMT
Daniel G. McChesney, M.S., PhD Director, Office of Surveillance & Compliance Center for Veterinary Medicine, FDA

Edwin Melendez

Tue, 01 Sep 2009 16:03:40 GMT
Edwin Melendez, Consumer Safety Officer, CDER, FDA

Karen Migliaccio

Tue, 01 Sep 2009 16:01:11 GMT
Karen Migliaccio, President, migliaccio Consulting, LLC

Charles Mignosa

Wed, 02 Sep 2009 15:10:28 GMT
Charles Mignosa, President, Business systems Architects, LLC

Paolomi Mukherji

Thu, 13 Aug 2009 17:00:50 GMT
Paolomi Mukherji, Manager, Clarkston Consulting

Richard Norgard

Fri, 10 Jul 2009 10:24:21 GMT
Richard Norgard Executive Director, Global Manufacturing Compliance, Pfizer

Stephen Notarnicola, PhD

Tue, 01 Sep 2009 15:57:48 GMT
Stephen Notarnicola, PhD, Principal Investigator,Biogen Idec

Ulku Oktem, PhD

Fri, 22 May 2009 12:38:49 GMT
Ulku Oktem, PhD, Adjunct Professor, Operations and Information Management Department, Wharton School of the University of Pennsylvania

Gerard Pearce

Fri, 10 Jul 2009 10:26:45 GMT
Gerard Pearce, Executive Vice President, SQA Services Inc.

Michael J. Popek, M.S.

Tue, 01 Sep 2009 15:56:24 GMT
Michael J. Popek, M.S., Supervisory Microbiologist, Center for Veterinary Medicine, FDA

Anurag S. Rathore, PhD

Fri, 22 May 2009 12:34:00 GMT
Anurag S. Rathore, PhD, Process Development, Amgen, Inc.

Edwin Rivera-Martinez

Tue, 01 Sep 2009 15:54:33 GMT
Edwin Rivera-Martinez, Chief, Manufacturing Assessment and Preapproval Complaince Branch Division of Manufacturing and Product Quality, Office of Compliance,CDER, FDA

Stephan Roenninger, PhD

Fri, 22 May 2009 13:48:41 GMT
Stephan Roenninger, PhD Global Quality Manager, F. Hoffmann-La Roche, Ltd.

Barbara A. Ryan

Fri, 22 May 2009 12:05:41 GMT
Barbara A. Ryan, Analyst, Deutsche Bank

Swroop Sahota, PhD

Tue, 26 May 2009 12:34:42 GMT
Swroop Sahota, PhD Vice-president of Global Quality Services, Schering-Plough

Robert Sausville

Tue, 01 Sep 2009 15:53:27 GMT
Robert Sausville, Supervisor, Consumer Safety,CBER, FDA

David R. Schoneker

Tue, 01 Sep 2009 15:50:18 GMT
David R. Schoneker, Director of Global Regulatory Affairs, Colorcon

Jacqueline Scott, J.D., M.L.

Fri, 22 May 2009 12:03:06 GMT
Jacqueline Scott, J.D., M.L., Professor, Harrison Institute for Public Law, Georgetown University

Joshua M. Sharfstein, MD

Wed, 27 May 2009 13:24:01 GMT
Joshua M. Sharfstein, MD, Principal Deputy Commissioner, FDA

James Shirey

Tue, 01 Sep 2009 15:49:13 GMT
James Shirey, Director/Team Leader, Pfizer, Inc.

Jeffrey Shuren, MD, J.D.

Fri, 10 Jul 2009 10:29:48 GMT
Jeffrey Shuren, MD, J.D. ,Associate Commissioner for Policy and Planning, FDA

Steven Silverman

Fri, 10 Jul 2009 10:33:38 GMT
Steven SilvermanAssistant Director, Office of Compliance, FDA

James Skrine

Fri, 22 May 2009 13:52:30 GMT
James Skrine, Executive Director / Site Head, Quality, Amgen, Inc.

Janeen Skutnik

Fri, 10 Jul 2009 10:35:48 GMT
Janeen Skutnik, Director/Team Leader of Quality & Regulatory Policy, Pfizer

Douglas Stearn

Tue, 01 Sep 2009 15:47:56 GMT
Douglas Stearn, Director, Division of Compliance Policy, Office of Regulatory Affairs, FDA

Wayne Taylor, PhD

Fri, 22 May 2009 13:59:01 GMT
Wayne Taylor, PhD, Chairman, Taylor Enterprises

Lynn Torbeck

Tue, 01 Sep 2009 15:46:27 GMT
Lynn Torbeck, Principal Statistician, Torbeck and Assoc., Inc.

Wallace Torres

Fri, 22 May 2009 14:02:42 GMT
Wallace Torres, QuaSaR Program Leader, Hoffman-La Roche Inc.

Kimberly Trautman

Fri, 10 Jul 2009 10:43:39 GMT
Kimberly Trautman Medical Device GMP/Quality Systems Expert, FDA

Timothy Ulatowski

Fri, 10 Jul 2009 10:50:56 GMT
Timothy Ulatowski, Director, Office of Compliance, CDRH, FDA

David Ulrich

Tue, 01 Sep 2009 15:45:00 GMT
David Ulrich, Distribution and Logistics QA Manager, Abbott Laboratories

Martin VanTrieste

Fri, 10 Jul 2009 10:53:14 GMT
Martin VanTrieste Vice President Commercial Quality, Amgen, Inc.

Greg Walker

Tue, 01 Sep 2009 15:43:37 GMT
Greg Walker, Director, Wyeth Pharmaceuticals

Steven Wolfgang, PhD

Fri, 10 Jul 2009 10:55:36 GMT
Steven Wolfgang, PhD, Consumer Safety Officer, CDER, FDA

Janet Woodcock, M.D.

Tue, 01 Sep 2009 16:54:25 GMT
Janet Woodcock, M.D., Director, CDER, FDA

Klaus Wuttke

Tue, 01 Sep 2009 15:36:25 GMT
Klaus Wuttke, DirectorGerresheimer Bunde GmbH

Victor Yamauchi

Tue, 01 Sep 2009 15:33:02 GMT
Victor Yamauchi, Director of Supplier Quality, Amgen, Inc.

Barbara Zinck

Fri, 10 Jul 2009 10:59:14 GMT
Barbara Zinck Senior Director, Corporate Compliance, Cambrex Corporation

Recommended Reading

Thu, 23 Jul 2009 07:50:56 GMT
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Assessing Risks of Changing Sterile Drug Manufacturing Sites

Mon, 06 Jul 2009 14:17:37 GMT
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Brochure

Wed, 06 May 2009 14:33:07 GMT
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Agenda

Thu, 02 Apr 2009 15:50:13 GMT
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Sept 13

Thu, 02 Apr 2009 15:54:07 GMT
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Sept 14

Thu, 02 Apr 2009 15:55:19 GMT
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Sept 15

Thu, 02 Apr 2009 16:03:06 GMT
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Sept 16

Thu, 02 Apr 2009 16:07:29 GMT
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Sept 17

Thu, 02 Apr 2009 16:08:26 GMT
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Sept 18

Fri, 24 Apr 2009 09:47:53 GMT
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Registration Fees

Fri, 31 Oct 2008 08:58:23 GMT
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Exhibition and Sponsorships

Thu, 30 Oct 2008 12:37:57 GMT
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Himedia Laboratories PVT. LTD.

Tue, 08 Sep 2009 14:32:16 GMT
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Remel, Inc.

Wed, 02 Sep 2009 14:08:27 GMT
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Food & Drug Administration- DCRMS Division, Drug Registration and Listing Team (DRLS, eDRLS)

Thu, 27 Aug 2009 15:28:07 GMT
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Working Words Inc.

Tue, 18 Aug 2009 13:40:17 GMT
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SQA Services, Inc.

Tue, 18 Aug 2009 13:15:59 GMT
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Precision Medical Products, Inc.

Tue, 18 Aug 2009 11:20:47 GMT
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Novatek International

Tue, 18 Aug 2009 10:19:02 GMT
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Food & Drug Administration - Center for Drug Evaluation & Research

Tue, 18 Aug 2009 09:26:58 GMT
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Sponsorship Agreement Form

Thu, 13 Aug 2009 15:21:21 GMT
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Sponsorship Package Descriptions

Thu, 13 Aug 2009 15:14:24 GMT
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Accugenix, Inc.

Wed, 25 Mar 2009 08:43:48 GMT
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American Stelmi Corporation

Wed, 06 May 2009 14:55:03 GMT
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Associates of Cape Cod, Inc.

Wed, 25 Mar 2009 08:45:30 GMT
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Biocorp, Inc.

Fri, 05 Dec 2008 09:28:54 GMT
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bioMerieux Industry, Inc.

Thu, 23 Jul 2009 09:10:09 GMT
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BioProcess International

Thu, 18 Jun 2009 13:44:32 GMT
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BioReliance

Wed, 24 Dec 2008 10:40:17 GMT
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Bioscience International, Inc.

Mon, 08 Jun 2009 09:03:35 GMT
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Commissioning Agents, Inc.

Fri, 05 Dec 2008 09:31:35 GMT
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DBA Pharma

Wed, 21 Jan 2009 08:42:35 GMT
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EmpiriStat, Inc.

Wed, 25 Mar 2009 08:03:20 GMT
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Food & Drug Administration - Center for Biologics Evaluation & Research

Wed, 01 Apr 2009 12:20:42 GMT
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General Physics Corporation

Fri, 05 Dec 2008 09:34:06 GMT
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Genesis Packaging Technologies, Inc.

Fri, 15 May 2009 08:13:00 GMT
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Hyde Engineering and Consulting

Mon, 04 May 2009 14:51:20 GMT
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Lyophilization Technology, Inc.

Mon, 15 Jun 2009 08:38:01 GMT
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Maas & Peither AG GMP-Publishing

Wed, 24 Dec 2008 11:02:12 GMT
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NNE Pharmaplan A/S

Thu, 09 Jul 2009 09:13:39 GMT
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PAREXEL Consulting

Wed, 25 Mar 2009 08:00:17 GMT
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Pharma-Bio Serv, Inc.

Mon, 27 Jul 2009 09:39:30 GMT
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Pharmaceutical Technology

Thu, 16 Jul 2009 07:52:55 GMT
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Regulatory Compliance Associates, Inc.

Wed, 24 Dec 2008 08:16:50 GMT
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SkillsPlus International, Inc.

Wed, 25 Mar 2009 08:12:54 GMT
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SOLABS

Mon, 04 May 2009 14:01:10 GMT
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Sparta Systems, Inc.

Fri, 05 Dec 2008 09:36:03 GMT
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VelQuest Corporation

Wed, 25 Mar 2009 08:15:40 GMT
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Veltek Associates, Inc.

Fri, 05 Dec 2008 09:38:02 GMT
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Exhibitor Contract

Mon, 24 Nov 2008 10:05:46 GMT
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Company Product Form

Mon, 24 Nov 2008 10:07:10 GMT
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Additional Exhibitor Registration Form

Mon, 24 Nov 2008 10:10:41 GMT
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Sponsorship Agreement Form

Fri, 17 Apr 2009 11:08:18 GMT
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Floor Plan

Mon, 24 Nov 2008 10:11:54 GMT
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Exhibit Schedule and Hours

Tue, 02 Jun 2009 14:36:45 GMT
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Exhibitor Service Manual

Mon, 13 Jul 2009 13:08:30 GMT
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Electrical Rental Order Form

Thu, 30 Jul 2009 15:12:34 GMT
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Exhibitor Audio Visual Order Form

Thu, 30 Jul 2009 15:13:34 GMT
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Sponsor Logos

Wed, 03 Jun 2009 10:51:15 GMT
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Continuing Education Units

Wed, 15 Apr 2009 16:07:18 GMT
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Program Planning Committee

Wed, 19 Nov 2008 11:44:07 GMT
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PDA Combination Products Workshop

Thu, 30 Oct 2008 13:17:30 GMT
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Registration Form

Thu, 30 Oct 2008 12:54:57 GMT
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2009 PDA Regulatory Conference Courses

Thu, 30 Oct 2008 12:49:53 GMT
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Web banner

Thu, 30 Oct 2008 12:41:35 GMT
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Venue

Wed, 08 Apr 2009 15:06:29 GMT
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About Washington, D.C.

Wed, 08 Apr 2009 15:28:16 GMT
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Tours

Wed, 08 Apr 2009 15:45:27 GMT
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Dining

Wed, 08 Apr 2009 15:46:07 GMT
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About Washington, D.C.

Wed, 08 Apr 2009 15:09:35 GMT
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Tours

Wed, 08 Apr 2009 15:29:24 GMT
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Dining

Wed, 08 Apr 2009 15:37:40 GMT
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2009 PDA/FDA Joint Regulatory Conference

Wed, 08 Apr 2009 15:26:54 GMT
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