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ISPE CGMP Conference 2012 Wrap Up

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Find out what you missed at one of the most important events of the year! 

The CGMP Conference was a complete success and well attended with support from over 300 attendees. FDA regulators and industry leaders offered informative points of view regarding the industry and its future.

"The information that was presented at the conference from some of the industry leaders and FDA was unbelievably informative, eye opening, and relatable to our day to day operations and challenges. It was a great experience and opportunity to have an open discussion with the FDA and industry leaders. I would highly recommend this to anyone."

- Michael J. Callahan, Manufacturing Supervisor, Buffer Prep/Alewife, Shire

In-depth educational sessions, training courses and networking events provided Members the opportunity to exchange ideas with industry experts and colleagues. Find out what you missed below.


  • Plenary Session – Get access to the in-depth presentations from FDA and industry speakers.
  • New Guide Launch – Find out which Guides where launched!
  • Networking Events – Meet the Press provided a provocative dialogue between industry and FDA leadership. Find out the details!

Leave your notes behind?


THANK YOU to all of our delegates, speakers and exhibitors!

Check out our Global Events calendar for a comprehensive list of all upcoming conferences

Plenary Sessions 

The Plenary Session kicked off the Conference with a mix of industry and regulatory speakers.

“Andy’s talk was about priorities and about motivation for being in this industry. It was a very clear message about what we should prioritize.”

-Anders Brummerstedt, CPIP, Senior Project Manager and Computer Systems Quality Specialist, PEC, Denmark

Plenary Session handouts are now available for download.

Janet Woodcock Photo Vision for Quality in the 21st Century
Janet Woodcock, Director CDER, FDA, USA
Andy Skibo Photo High Quality in a Lean Manufacturing World
Andy Skibo, Executive Vice President, Operations, MedImmune, USA
Deborah Autor Photo Global Quality
Deborah Autor, Deputy Commissioner for Global Regulatory Operations and Policy, FDA, USA
Ilisa Bernstein Photo Future Vision for the Office of Compliance
Ilisa Bernstein, Acting Director, Office of Compliance, CDER, FDA, USA
Mary Oates Photo Culture of Quality
Mary Oates, Vice President of Global Quality Operations, Pfizer, USA
Gerald Heddell Photo International Regulatory Perspective: What's New in Europe?
Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA, UK

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Conference Delegates received 20% off of the following new guides! Don’t forget to purchase yours today and stay current with industry trends!

New Releases

PQLI 3 Cover Image ISPE Guide Series: Product Quality Lifecycle Implementation (PQLI®) from Concept to Continual Improvement Part 3 – Change Management System as a Key Element of a Pharmaceutical Quality System
ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment (Second Edition)

Look for the following Guides Coming Soon!

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New Member Breakfast Photo
The CGMP Conference welcomed many New Members – helping make 
the New Member /First-Time Orientation Breakfast a complete success.

Meet the Press

There was a clear enthusiasm and commitment from both regulators and industry to share ideas and solve problems through this interactive dialog. View this PE Exclusive ( 299 KB) to find out the details on this event!

Conference Handouts 

Forget to turn in your conference evaluation?  

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Thank you to our Sponsors 

Pinnacle: Commissioning Agents - ISPE Pinnacle Sponsor

Host: Pharmatech - CGMP Conference Host Sponsor

Platinum: ProPharma Group - ISPE Platinum Sponsor

Silver: Qumas - ISPE Silver Sponsor

Reception: Interphex - ISPE CGMP Reception Sponsor

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Congratulations to the Exhibitors who won the following FREE advertising opportunities

ISPE Buyers Guide Booth

  • US Data Management - Free Standard Table Top
  • Commissioning Agents, Inc. - Full Page Ad in Exhibitor Directory
  • Hyde Engineering + Consulting, Inc. -1/2 Page Ad in Exhibitor Directory
  • Harness Solutions, Inc. - Enhanced Listing in Exhibitor Directory
  • Nivasoft, Inc. - Premium Listing in Buyers Guide
  • Vaisala, Inc. - Premium Listing in Buyers Guide
  • cGMP Validation LLC - 2 month Web button in Buyers Guide
  • US Data Management - 2 month Web button in Buyers Guide

The new ISPE Buyers Guide also made its debut! Enter your listing here.

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Host Sponsor

Platinum Sponsor

Silver Sponsor

Reception Sponsor