ISPE and
ISPE
andFDA
FDApresent
present
Redefining the C in CGMP
“
”
Creating, Implementing and Sustaining a Culture of Compliance
4 – 5 June 2012 • Baltimore, Maryland USA
if you were previously an ISPE Member.
ONLINE: www.ISPE.org/2012CGMPCompliance FAX: +1-813-264-2816
MAIL: ISPE, 600 N. Westshore Blvd., Suite 900, Tampa, FL, 33609, USA
FULL EDUCATION FEES
No refunds after 14 May
Please type or print clearly.
Check here
EARLY BIRD ENDS 7 MAY
ISPE ID # ______________________________________________
First Name _______________________________________MI___________Last Name_________________________________
Informal Badge Name ______________________________Chapter/Affiliate__________________________________________
Job Title______________________________________________ Email Address_______________________________________
Company______________________________________________ Business Address_____________________________________
State/Province________________________ Zip+4/Postcode_________________________ Country_______________________
On/Before 7 May
After 7 May
Current Member
$1,495
$1,695
N
ew Member
(Fee includes one-year ISPE
Membership, a $239 value)
$1,734
$1,934
Nonmember
$1,825
$2,035
Committee
$750
$750
Government
$500
$500
Business Tel____________________________________________ Business Fax______________________________________
See Special Pricing for Student Members, Academia and Emerging
Economies at www.ISPE.org/2012CGMPCompliance
Emergency Phone For Last Minute Meeting Updates: Cell Phone ________________________________________________________________
Special Meal Requirement
Kosher
Vegetarian
Gluten Free
or Home Phone _______________________________________________________________________________________________________
I wish to keep my data confidential and it is given only for use by ISPE and its local Chapters and Affiliates.
(This will exclude you from the Conference Attendee Listing, Member Directory and Exhibitor List.)
First Time Attendee
New Member
DAY 1– MONDAY, 4 JUNE (Choose one morning session and one afternoon session.)
09.00 – 09.45
Plenary Session 1 – V
ision for Quality in the 21st Century
09.45 – 10.30
Plenary Session 2 – Lean Manufacturing Without Compromising Quality
Janet Woodcock, Director CDER, FDA, USA
Andy Skibo, Executive Vice President, Operations, MedImmune, USA
11.00 – 12.15
1A
13.15 – 14.00
Plenary Session 3 – Global Quality
14.00 – 15.30
2A
16.00 – 17.00
Forum 1: Industry Lead Hot Topic Discussion Forum
B
enefits of PAI Readiness and Data
Integrity for Speedy Approvals
1B
W
hy It Pays to Continually Reinvest
in Your Facilities & Systems
2B
S
ustaining Compliance Consistency
throughout Your Supplier Networks
08.00 – 08.45
Plenary Session 4 – Future Vision for the Office of Compliance
08.45 – 09.30
Plenary Session 5 – Culture of Quality
Ilisa Bernstein, Acting Director, Office of Compliance, CDER, FDA, USA
Mary Oates, Head of Quality, Pfizer, USA
09.30 – 10.15
Plenary Session 6 – International Regulatory Perspective
11.00 – 12.30
3A
13.30 – 14.30
Forum 2: Meet the Press
15.15 – 17.00
4A
Gerald Heddell, Director of Inspection, Enforcement and Standards, MHRA, UK
Flexible Manufacturing
REGISTRATIONS REQUIRE PAYMENT ATTACHED
Substituting for __________________________________________________________________
(NONMEMBERS SUBSTITUTING FOR A MEMBER MUST PAY THE DIFFERENCE IN FEES)
Check enclosed payable to ISPE # __________________ in the amount of $ _________________
Bill credit card (circle type): VISA
MC
AMEX
Card number ____________________________________________________________________
Exp. date ______________ Name of cardholder_________________________________________
(AS IT APPEARS ON CARD)
DAY 2– TUESDAY, 5 JUNE (Choose one morning session and one afternoon session.)
W
atching Your Process – Assuring
Quality and Process Performance
PAYMENT METHOD —
(MUST BE DRAWN ON A US BANK)
Deborah Autor, Deputy Commissioner for Global Affairs, FDA, USA
R
egulatory Success in a Cloud
Environment
HOTEL: Hotel accommodations and hotel fees are separate from Conference registration fees. For
room reservations at the Conference venue, Renaissance Baltimore Harborplace Hotel, 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 7 May 2012, or until the room
block is full, whichever comes first. Please contact the hotel as early as possible to make your
reservations to ensure you are in the headquarters hotel.
3B
Q
uality Risk Management: Using Risk
Assessments in Manufacturing
4B
CAPA: Case Studies
Cardholder signature _______________________________________________________________
Registration is confirmed only when payment is received. Please send registration form with
payment to:
ISPE Headquarters,
600 N. Westshore Blvd., Suite 900, Tampa, Florida 33609 USA
Tel: +1-813-960-2105 • Fax: +1-813-264-2816
FEIN #59-2009272 • www.ISPE.org
Conference Cancellations - Cancellations must be made in writing. If cancellations are received by 14
May 2012, 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.