קטגוריה: PDA - העמותה לקידום המדע והטכנולוגיה הפרמצבטית בישראל
PDA Meeting: ICH Q9, Q10 - The Pharmaceutical Quality System and Risk Management
תאריך: 21 מרץ 2010
מיקום הקורס:  כפר המכביה, רמת גן
שפת הקורס: אנגלית
משך הפעילות: יום לימודים מלא
שעות: 14.30-18.00
התכנסות והרשמה: 14:00
נקודות זכות: 0
מק''ט: P10701
 


Invitation to
Half Day Seminar

With
Zena Kaufman

Division Vice President - Global Pharmaceutical Operations QA - Abbott US/PR

Sunday March 21, 2010
14:00-18:30
Kfar Hamaccabiah, Ramat Gan

SEMINAR PROGRAM

Duration

Topic

14:00 - 14:30

Registration and Coffee

14:30 - 16:00

An Insider & User's Guide to Understanding
ICH Q10: Pharmaceutical Quality Systems

16:00 – 16:30

Coffee Break

16:30 – 17:15

Risk Management with Practical Examples

17:15 – 18:30

Facilitated Risk Management Session
Bring your questions/issues and we will work as a group
to design Risk Assessment approaches

About the Speaker:
Zena Kaufman
Zena is Abbott’s Divisional Vice President, Global Pharmaceutical Operations, Quality Assurance for the US/ Puerto Rico region. Previous to joining Abbott in February 2006 in a corporate quality and regulatory role for external regulatory and compliance programs, Zena was Director of Quality at Searle and remained in the Quality organization through the mergers/acquisitions from Searle, Pharmacia and Pfizer. Within Pfizer, her role as Sr. Director of Regulatory & Compliance Initiatives included site compliance assessments and external advocacy.
She is past chair of the Parenteral Drug Association's RAQC committee, current chair of the PhRMA Technical Leadership Committee and a member of the PhRMA Quality Technical Group. Representing PhRMA, she had the privilege of serving as part of the Expert Working Group for ICH Q10, "Pharmaceutical Quality Systems". She has a bachelor's degree from Queens College in Queens, NY and a master's degree from the State University of NY at Stony Brook.

Participation fees:
PDA members - 450 NIS
Non members - 650 NIS

Registration is mandatory, please register here


 

Organized & Produced by
Bioforum Applied Knowledge Center


Bioforum - Applied Knowledge Center
Lev Hakongressim, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail: bioforum@bioforum.co.il

site: www.bioforum.co.il

 

 
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