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.

Highlights

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!

Exhibitor

Sponsors
Exhibitor Give-Away Drawings
Exhibitor Directory – See who’s been added!

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.

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

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Bookstore

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

	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!

ISPE Good Practice Guide: Ozone
ISPE Good Practice Guide: Quality Laboratory Facilities
ISPE Good Practice Guide: Packaging, Labeling and Warehouse Facilities

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Networking

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 ( Adobe PDF 299 KB) to find out the details on this event!