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Fees and Registration

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To register you will need to choose from one morning session and one afternoon session each day. You may attend all Plenary Sessions and Forums.

Day 1 - Monday, 4 June 2012 (Choose one morning session and one afternoon session)
Morning Plenary
All Attend
Plenary Session 1 – Vision for Quality in the 21st Century
Janet Woodcock, Director CDER, FDA, USA
Plenary Session 2 – Lean Manufacturing Without Compromising Quality
Andy Skibo, Executive Vice President, Operations, MedImmune, USA
Choose One 1A: Benefits of PAI Readiness and Data Integrity for Speedy Approvals 1B: Why It Pays to Continually Reinvest in Your Facilities & Systems
Afternoon Plenary
All Attend
Plenary Session 3 – Global Quality
Deborah Autor, Deputy Commissioner for Global Affairs, FDA, USA
Choose One 2A: Regulatory Success in a Cloud Environment 2B: Sustaining Compliance Consistency throughout Your Supplier Networks
Afternoon Forum
All Attend
Forum 1: Industry-Led Hot Topic Discussion Forum
Day 2 - Tuesday, 5 June 2012 (Choose one morning session and one afternoon session)
Morning Plenary
All Attend
Plenary Session 4 – Future Vision for the Office of Compliance
Ilisa Bernstein, Acting Director, Office of Compliance, CDER, FDA, USA
Plenary Session 5 – Culture of Quality
Mary Oates, Head of Quality, Pfizer, USA
Plenary Session 6 – International Regulatory Perspective
Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA, UK
Choose One 3A: Watching Your Process – Assuring Quality in Process Performance 3B: Quality Risk Management: Using Risk Assessments in Manufacturing
Afternoon Forum
All Attend
Forum 2: Meet the Press
Choose One 4A: Flexible Manufacturing 4B: CAPA Case Studies
Fees
Type Early Bird (on or before 7 May 2012) Regular/Onsite (after 7 May 2012)
Member $1,495 $1,695
New Member $1,734 $1,934
Non-Member $1,825 $2,035
Committee $750 $750
Government $500 $500
Student $200 $200
Academia/EE $750 $850

How to Register 

Or send registration form with payment to:
ISPE Headquarters, 600 N. Westshore Blvd., Ste. 900,Tampa, Florida 33609 USA
Tel: +1-813-960-2105 • Fax: +1-813-264-2816 • FEIN #59-2009272

Registration is confirmed only when payment is received.

Conference Cancellations 

Cancellations must be made in writing. If cancellations are received by 14 May, a full refund, minus a 10% handling fee (maximum of $100), will be issued. After that time, no refunds will be granted. If you are unable to attend, substitutions will be accepted. However, nonmembers substituting for a Member must pay difference in fees prior to the start of the event. ISPE is not responsible for lost airfare due to cancellations.

Hotel

For room reservations at the Conference venue, Renaissance Baltimore Harborplace Hotel, Baltimore, Maryland USA., call tel: 1-800-HOTELS1 or +1-410-547-1200. When making your reservation by phone, mention ISPE for a discounted rate of $195 single/double. This rate is good until 25 May 2012, or until the room block is full, whichever comes first. Or you may make your reservation online. Please contact the hotel as early as possible to make your reservations to ensure you are in the headquarters hotel. We thank you for staying at the Renaissance as this enables ISPE to meet contract requirements

Special Requirements 

If you require special accommodations to participate, such as a wheelchair-accessible room or a sign language interpreter, please attach a written description of your needs to your registration form. If you have questions, please contact ISPE at tel: +1-813-960-2105 or email: ask@ispe.org. Please mark vegetarian, gluten free, or kosher, if needed, in the Special Meal Requirement box on the registration form.

Contact Information 

In case we need to contact you regarding event changes, please provide a phone number where you may be reached during non-business hours (either home or cell). Please e-mail this information to ISPE Member Services at ask@ispe.org

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