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 |
