2013 Annual Meeting

Young Professionals

Register Now!

The fee to attend the conference for ISPE YP Members is $1205. If you are not an ISPE Member and think you may qualify, please email Member Services at ask@ispe.org or call +1-813-960-2105.  
We look forward to seeing you there! 

YP Justification Letter ( 16 KB)

YP Testimonials ( 23 KB)

Daily Schedule 

Drug Survey Report Cover

Meet the Press Photo

Sunday, 3 November

12.30 – 13.30 Young Professionals Luncheon and Orientation

Enjoy lunch and fellowship with your young professional peers. You’ll meet other ISPE Members, learn about industry trends and make valuable connections to boost your career potential.

15.00 – 16.00 Student Poster Set-up

17.00 – 19.00 Welcome Reception in the Exhibit Hall

Network over hors d’oeuvres, catch up with old friends and meet new ones. More than 200 suppliers will be onsite to answer questions and share industry knowledge. Be sure to stop by the Facility of the Year Awards booth to learn about the 2013 Category Winners and their innovative projects.


Meet the Press Photo

Monday, 4 November

08.30 – 12.00 Plenary Presentations

13.30 – 17.00 International Student Poster Competition

19.30 – 22.00 Young Professionals Networking Event at

Southern Hospitality (offsite) ( http://www.sohodc.com/) link

Unwind from a busy day with an evening of food and fun hosted by ISPE’s Young Professionals. This year’s event will take place at Southern Hospitality restaurant, located in the trendy Adams Morgan neighborhood. Share a glass of wine and heavy hors d’oeuvres while getting to know your industry peers (cash bar).

Southern Hospitality Restaurant

1815 Adams Mill Rd NW (At Columbia Rd NW)
Washington, DC 20009  
202) 588-0411

Meet the Press Photo


Meet the Press Photo

Tuesday, 5 November

07.30 – 08.15 Young Professionals Meet and Greet

Join the Young Professionals Tuesday and Wednesday mornings for an opportunity to meet like-minded professionals and learn about the educational sessions offered in the NEW education track for young professionals: “Science-Engineering- Compliance: Essentials of GMP Manufacturing.” Brief introductions and overviews of the session topics will prepare you for each day’s education opportunities. Meet some new faces or find a mentor to join you during the educational sessions. All are welcome, to attend – Young Professionals and our “Seasoned Veterans” alike!


12.00 – 13.30 Membership Luncheon and Awards

Join ISPE leadership and colleagues for lunch as we review ISPE accomplishments from 2013 and look ahead to 2014 goals. Special recognition awards will be presented to Members, Affiliates, Chapters, Committees, Companies, Authors and Students who have made significant contributions this year.

International Student Poster Competition Winners Announced!

14.00 – 17.30 Affiliate/Chapter Young Professionals and

Students Best Practices Workshop

Meet the Press Photo

Wednesday, 6 November

07.00 – 07.45 Young Professionals Meet and Greet

08.00 – 13.00 Regulatory Sessions

14.00 – 15.30 Global Regulatory Summit

13.00 – 18.00 Manufacturing Facility Tour: AstraZeneca 

Look at top level facilities and learn the stories of their operations. Limited seating available — Please call ISPE at 1-813-960-2105 to reserve your spot today!

Sponsored by AstraZeneca

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Young Professionals Sessions:

Science-Engineering-Compliance: Essentials of GMP Manufacturing

Track Leaders: Jennifer Lauria-Clark, SE Manager Technical Services, Commissioning Agents, Inc., USA Brody Stara, Process Engineer, CRB Consulting Engineers Inc., USA

601-YP: Understanding Your Industry ( 150 KB)

This session will round out your view of the pharmaceutical world. Topics will give intermediate looks at traditional pharmaceutical vs. biotech practices and the regulatory hurdles unique to each. Learn the process companies must go through once a drug is discovered; learn the process of traditional pharmaceutical manufacturing; and discuss a sample biotech process and its unique challenges.

  • Leader: Brody Stara, Process Engineer, CRB Consulting Engineers, USA
  • Janet Bowen, VP Compliance Services, Commissioning Agents, Inc, USA
  • Timothy Fields, Vice President, Quality, Protein Sciences Corporation, USA
  • Alice Redmond, Ph.D., Vice President, Commissioning Agents Inc, Ireland
  • Jonathan Romero, Associate Director Global Eng, Biogen Idec, USA
  • Andre Walker, CPIP, Director, Mfg Sciences, Biogen Idec, USA

602-YP: Integrating Quality into Your Project ( 151 KB)

Whether big or small, projects must be executed with a high level of quality. This session will educate attendees on project risk, and how it is mitigated and managed. The session will show the importance of integrating quality into your processes, and the impact of validation in regards to Quality Risk Management. This session will also take a look at the importance of Information Management Systems. You will learn what a QMS is and its importance to your company; how to assess, mitigate and manage risks to your processes; and the 3 stages of Process Validation and their importance to a successful qualification.

  • Leader: Brody Stara, Process Engineer, CRB Consulting Engineers, USA
  • Nikolas Burlew, VP Quality Systems, Clinipace, Inc., USA
  • John Hannon, Vice President, SE Region, Commissioning Agents Inc, USA
  • Michael Kimball, Executive Dir, Transdermal Dev, Actavis plc, USA
  • James Lambert, Baxter,
  • Dawn Tavalsky, Director, Genzyme Corp., USA


603-YP: Critical Components to Successful Manufacturing ( 151 KB)

This session will explore many of the critical aspects required for successful manufacturing facilities along with their relationship to the products being produced. Discussions will range from the impact of automation on productivity and quality to facilities and systems to methods of sterilization.


604-YP: Effective Project Leadership ( 152 KB)

Every project needs a good leader. This session lays out what project management is, ways to make you a better PM, and case studies of good project management. The focus will be on identifying the role of a good project manager and the qualities/traits to excel as a leader, not just a manager, utilizing case studies to show good and bad ways to lead your team.

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Thank you to our Top Tier Sponsors

  • Pinnacle Sponsor
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  • Host Sponsor
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  • Bronze Sponsor
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