FDA/Xavier University Global Outsourcing Conference 2010

 

 Pharmaceutical Global Outsourcing Conference POST-CONFERENCE CENTRAL

 Solutions for a Changing World

Thank You to everyone who made GOC 2010 such a success!


What Was Shared

~ Lean Six Sigma process outlined for Quality Agreement development by Eli Lilly's Gwyn Murdoch

~ How to Audit the Supply Chain was detailed by Colorcon adn IPEC America's Dave Schoneker

Link to Presentations

What Was News

~ New regulation proposals announced by FDA's Brian Hasselbach

~ New regulation announced by MHRA's Rachel Carmichael

Photo Gallery

 

Percentage of Participant Titles from MedCon 2010, an FDA and Xavier University co-sponsored Medical Device Conference

Who Was Here

~ 112 Participants, including representatives from Israel, the United Kingdom, Canada and the United States

Demographics

 

What's Coming Next!

~ GOC Forums: Join the Conversation. Sign Me Up!

~ Save the Date for GOC 2011. Keep Me Posted!

 

Speaker Biographies

Conference Recap:

The Inaugural Global Outsourcing Resources conference was a resounding success, with more than 115 participants from the U.K, Canada, Israel and the United States coming together to join the conversation about Outsourcing Challenges and Opportunities.

Over 2 and 1/2 days, conference attendees developed action plans to implement key learnings and presented possible solutions in small groups on subjects that spanned seventeen presentations, including:

  • FDA Forensic Laboratory Case Studies
  • Global Outsourcing, Current Challenges and Future Direction - a UK Inspector's View
  • FDA Issues for Inspections of Contract Sites
  • Public Health Challenges for the Quality of Human Drugs
  • The Challenge of Compliance in Asia
  • Compliance Strategy of a Global Contract Organization
  • Contract Organization Selection Process
  • The Client Selection Process
  • Drug Master File Fitness--Regulatory Challenges
  • Streamlining the Contract Manufacturing Quality Agreement Process
  • ICH Triple Q's
  • Risk-based Performance Management
  • Rebuilding the Trust
  • Supply Chain Transparency and Pedigree
  • Rx-360 Initiatives
  • How to Audit the Supply Chain
  • IPEC Initiatives

It was a jam-packed conference experience, and we'd like to especially thank our GOC 2010 Committee for their timeless dedication in making it come together.

To those who attended and those who wish they had--we look forward to welcoming you to GOC 2011, Oct. 2-5 2011. Click Here to keep informed of latest conference developments!

SAVE THE DATE!
GOC 2011
October 2-5 , 2011GOC 2010 in the News

The fast-paced GOC 2010 conference drew attention from around the nation--and the world!

FDA plans to revise cGMP Guide Focusing on Outsourcing and Raw Materials - ECA

FDA Fast-Tracking Supply Chain cGMP Upgrades; Other GMP Changes, Quality Agreement Guidance Taking Shape - IPQ

EU Moving to Tighten GMP Requirements on Outsourcing and Supply Chain Control - IPQ

FDA Wants to See More Transparency Between Drug Companies and Contractors on Sponsor’s Application and Contractor’s GMP Status - IPQ

A Special Thank You
to Our Sponsors

Xavier University would like to thank the following Participating Organizations for the financial support* of this conference event.

*The participating organizations listed below are not party to the agreement between Xavier University and the FDA, but rather have agreed to financially support Xavier University for hosting the conference.

FDA/Xavier University Global Outsourcing Conference Platinum Participating Organization: Elanco                           Patheon. An FDA / Xavier University Co-Sponsored Medical Device Conference Participating Organization.          Catalent. An FDA / Xavier University Co-Sponsored Medical Device Conference Participating Organization.

 RX 360 An International Pharmaceutical Supply Chain Consortium is proud to be a participating organization for the Xavier University and FDA Co-sponsored Global Outsourcing Conference: GOC 2010

     Acceleration is a proud participating organization of FDA and Xavier University Co-Sponsored Global Outsourcing Conference: GOC 2010                           American Thermal Instruments, ATI is a participating organization for the Xavier University and FDA co-sponsored Global Outsourcing Conference: GOC 2010

 

Bio Ohio is a participating organization for MedCon, a Xavier University and FDA co-sponsored event for the medical device industry.                 E-Beam is proud to be a participating organization for the Xavier University and FDA sponsored Medical Device Conference: MedCon 2010                            

 

Dasan Medichem is proud to be a participating organization for the FDA and Xavier University co-sponsored Pharmaceutical Global Outsourcing Conference GOC 2010                       Shire is proud to be a participating organization for the FDA and Xavier University Co-Sponsored Pharmaceutical Global Outsourcing Conference: GOC 2010    

              KHDI is proud to be a participating organization for the FDA and Xavier University Co-Sponsored Pharmaceutical Global Outsourcing Conference: GOC 2010

Xavier Med-XU resources and LinksRelated Links

 

 

OverheardFeedback from Conference Participants

"This is by far the best and most relevant conference I have ever attended in my career. The presentations were crisp and informative."

"Great conference – good information and workable solutions!"

"The conference theme really echoed ways for us to work better together – unique!"

"Honestly, one of the best I’ve ever been to!"

"This was the best conference I have attended in years. Completely applicable to what I do. This conference allowed me the opportunity to network, benchmark, and gain additional knowledge."

"Well executed/professional conference!"

"Very pertinent information."

"The frankness and openness of the FDA was great."

"Excellent job. Good variety of topics."

"Well organized with excellent content."

"This was the best conference I have ever been to."

"I love the solution-focus of the conference."

"The level of speaker competence and enthusiasm was above expectations."

"I’ve never been to a conference where so many speakers were competent, shared real information, and were great presenters."

"This was the most unique conference I have ever been to where every presentation was focused on the overall theme and the speakers were so engaging."

"I loved the live polling – would hope to see this again next year!!"

"Excellent cross section of players in the CMO space. Great to hear perspective and detailed comments from presenters."

"Outstanding speakers and content!"

"Can’t wait to see the 2011 information!"


 

Attending Organizations

  • Acceleration
  • Alkermes, Inc.
  • American Thermal Instruments
  • Amgen, Inc
  • Anderson Packaging Inc.
  • ARCA Biopharma Inc.
  • Banner Pharmacaps
  • BioConvergence LLC
  • Biotech PharmaFlow Ltd.
  • Cardinal Health
  • Catalent Pharma Solutions
  • Celsus Laboratories
  • Colorcon
  • Covidien
  • CWS
  • Debra L. Pagano, FDA Consultants LLC
  • DLA Piper LLP (US)
  • E-BEAM Services, Inc.
  • Elanco Animal Health
  • Eli Lilly and Company
  • Endo Pharmaceuticals
  • Eurand
  • FDA
  • FDA Forensic Chemistry Center
  • FDA, CDER
  • Forest Pharmaceuticals
  • GlaxoSmithKline Consumer Healthcare
  • IntegRx, Inc
  • International Pharmaceutical Quality
  • King Pharmaceuticals
  • LevoPharm LLC
  • Meda Pharmaceuticals
  • Medicis Pharmaceuticals
  • Merck & Co., Inc.
  • OSO BioPharmaceuticals Manufacturing LLS
  • Patheon, Inc.
  • Patheon, Inc.
  • Perrigo Co.
  • Pfizer, Inc.
  • Procter & Gamble
  • Raland Technologies LLC
  • Safis Solutions, LLC
  • Sandoz
  • Shire Pharmaceuticals
  • TEVA Pharmaceutical Industries
  • Transcept Pharmaceuticals
  • UK Medicines Healthcare Products Regulatory Agency (MHRA)
  • Upsher-Smith Pharmaceuticals
  • VIVUS
  • VVF Kansas, LLC
  • Warner Chilcott PLC
  • Watson Pharmaceuticals, Inc.
  • Xanodyne Pharmaceuticals, Inc.
  • Xavier Leadership Center
  • Xavier University
  • Xcelience LLC