Organized by:
Mordechai Izhar, Ludan Engineering


The Serialization will be enforced by FDA in November 2018 and by EMA in February 2019.

Agenda:

13:00-13:30

Registration

13:30-13:45 Opening Mordechai Izhar
QA and Validation Manager
Ludan Engineering Israel
13:45-14:30 Introduction to Serialization, Why We Need It, Regulation Outcome and Challenges

Michael Atzmon
Sr. Mgr, Quality Improvement
Teva Pharmaceuticals

14:30-15:15 Serialization Overall Concept, Serialization Requirements of National Regulators, Equipment and Packaging Lines Qualification Alex Primak
QA-IT manager and Serialization program lead, Omrix Biopharmaceuticals, J&J
15:15-15:45 Coffee Break
15:45-16:30 Practical Serialization, Outsourcing For Small and Big Clients Zeev Blajwajs
Pitkit CEO
16:30-17:00 Panel discussion for Q&A

Note: the program and speakers are tentative and subject to change without prior notice.

Target Audience:

QA, RA, IT, validation, engineering, production and employee dealing working with CMOs.

Participation Fees:
PDA members - 450 NIS
Non members - 550 NIS 

Organized & Produced by
Bioforum - Applied Knowledge Center
Golda Meir 3, 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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