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.
|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|
|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|
|Forum 1: Industry-Led Hot Topic Discussion Forum|
|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|
|Forum 2: Meet the Press|
|Choose One||4A: Flexible Manufacturing||4B: CAPA Case Studies|
|Type||Early Bird (on or before 7 May 2012)||Regular/Onsite (after 7 May 2012)|
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.
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.
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
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: email@example.com. Please mark vegetarian, gluten free, or kosher, if needed, in the Special Meal Requirement box on the registration form.
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 firstname.lastname@example.org