Lessons from 483s Wrap Up

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Conference Highlights

The ISPE Lessons from 483s Conference has concluded and was hailed as a big success by attendees. The combination of relevant Keynote Sessions, in-depth educational tracks, training, and networking events such as receptions, the New Member/First-Time Attendee Breakfast and Exhibitor Give-Away Drawings provided a platform for all Members to exchange ideas, hear from experts and industry leaders and meet old and new friends.

3 Keynote Sessions featuring the following Hot Topics
- Manufacturing Challenges during Pharmaceutical Development: Science-Based Lessons from Halaven
- A Biotech Perspective on Cost-Effective Operations
- 2020 Vision - The Next Generation of Manufacturing Facilities
Presentation from FDA’s Grace McNally during the Process Validation Track
International Pharmaceutical Quality Magazine covers Fred Rowley’s speech from the Oral Solid Dosage track
The launch of the New ISPE Good Practice Guide
Successful Networking Events including receptions, lunches and off-site events
Winners of the Exhibitor Give-Away Drawings

Other highlights:

See what delegates had to say about the conference or tell us yourself!
Final Delegate Handouts, Roster and Evaluation Form
Thank you to our Sponsors

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

Did you miss this event? ISPE will be hosting a similar conference, Lessons from Regulatory Non-Compliance in Brussels, Belgium on 17-18 September.

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

Conference Handouts

Download the final Delegate Handouts and Roster

Forget to turn your evaluation form in? Download and fill out the form. Then email it to Sara Dery-Hanlon or fax it to: 813-264-2816.

Biotech Evaluation Form ( 415 KB)
Oral Solid Dosage Evaluation Form ( 207 KB)
Process Validation Evaluation Form ( 294 KB)

Conference Tracks

Delegates were able to move between tracks allowing attendees to customize their education experience. The FDA’s Grace McNally discussion on the FDA View of Lifecycle Approach Implementation Status and Application to Legacy Products during the Process Validation Track was a clear conference highlight.

Read the article ( Adobe PDF 319 KB) from International Pharmaceutical Quality Magazine which covers Fred Rowley’s speech from the Oral Solid Dosage track.

See what delegates had to say about the Conference or tell us yourself!

“Great interactions & industry participation”

“Tons of valuable information available on pertinent topics”

“Lots of networking opportunities”

“Topics are current and relevant”

Follow the buzz

Bookstore

Comparator Management Cover

ISPE launched its new guidance document, ISPE Good Practice Guide: Comparator Management at the Lessons from 483s Conference. Order your copy today!

Keynote Sessions

Keynote Sessions are now available for download. Recordings are only available to attendees and speakers.

Download Keynote Recordings

	Michael Lewis, President, Eisai Product Creation Systems, USA Manufacturing Challenges During Pharmaceutical Development: Science-Based Lessons from Halaven
	Andy Skibo, Executive Vice President, MedImmune A Biotech Perspective on Cost-Effective Operations
	Chaz Calitri, Vice President, Global Engineering, Pfizer, USA 2020 Vision - The Next Generation of Manufacturing Facilities

Download Keynote Recordings

Networking

The New Member/First-Time Attendee Breakfast kicked off the morning giving first-time attendees and new ISPE Members a chance to build industry contacts. The evening receptions and CPIP™ information workshops were also a big hit!

“I thought the "Speed Networking" was a wonderful icebreaker and a great way to start off the conference!”

- Jessica Sasser, DSM Pharmaceuticals, Inc.

Coffee and Tea Table Set Up

Delegates also took advantage of the off-site networking opportunities after hours. Shuttles transported delegates to and from Bahama Breeze, Whiskey Joes and International Plaza where they enjoyed the Florida weather and beautiful sunset.

Thank you to our Sponsors

Pinnacle Sponsor
ISPE's 2012 Pinnacle Sponsor- Commissioning Agents

Host Sponsor

Silver Sponsor
Burkert Logo

Reception Sponsor
Interphex 2012

Exhibitors

Thanks to our Sponsors, winning delegates walked away with an exciting prizes, such as iPad 2, a digital camera, a portable DVD player and a Nintendo 3DS. Exhibitors didn’t walk away empty-handed; congratulations to the Exhibitors who won the following FREE advertising opportunities.

Buyers Guide Booth