The Serialization will be enforced by FDA in November 2018 and by EMA in February 2019.
QA and Validation Manager
Ludan Engineering Israel
|| Introduction to Serialization, Why We Need It, Regulation Outcome and Challenges
Sr. Mgr, Quality Improvement
||Serialization Overall Concept, Serialization Requirements of National Regulators, Equipment and Packaging Lines Qualification
QA-IT manager and Serialization program lead, Omrix Biopharmaceuticals, J&J
||Practical Serialization, Outsourcing For Small and Big Clients
||Panel discussion for Q&A
Note: the program and speakers are tentative and subject to change without prior notice.
QA, RA, IT, validation, engineering, production and employee dealing working with CMOs.
PDA members - 450 NIS
Non members - 550 NIS