PDA SEMINAR
Tuesday, September 4, 09:00 – 16:00h
Machon Ayalon, Rehovot
Organized by Raphy Bar and Sasha Nezlin
SCHEDULE:
| Duration |
Topic |
Speaker |
09:00 - 09:30 |
Registration |
| 09.30 – 09:45 |
Opening Remarks |
Rina Yamin
PDA Chapter President |
| 09.45 – 10.15 |
Handling of OOS – The Inspector's point of view |
Sarah Covrigaro
Institute for Standardization
and Control of Pharmaceuticals
Ministry of Health
|
| 10.15 – 10.45 |
Handling an OOS in a QC Lab |
Sasha Nezlin
Senior QA Manager
Omrix Biopharmaceuticals |
| 10.45 – 11.15 |
Coffee Break |
| 11.15 – 12.00 |
Uncertainty of Results and the impact of OOS |
Etty Feller
Head of Israel Laboratory
Accreditation Authority |
| 12.00 – 12.30 |
Non-conforming test results in R&D |
Alex Mirimsky
Head of Analytical R&D, CTS
Anat Puter
R&D QA Manager, CTS |
| 12.30 – 13.00 |
A statistical procedure for determining number of retests in case of OOS |
Drorit Lew
VP Quality, Production Plant, Kamada
|
| 13.00 – 14.00 |
Lunch |
| 14.00 – 14.45 |
Statistical treatment of unexpected results: Case studies |
Oren Bar-Ilan
Head of Non-clinical Statistics GBP, Teva-Abik |
| 14.45 – 15.15 |
Handling Deviations in the Microbiological Laboratory |
Orly Hammer, Ph.D.
Microbiological Laboratories Manager
Omrix Biopharmaceuticals
|
| 15.15– 16.00 |
Panel discussion |
Seminar Speakers;
Raphy Bar, Ph.D. |
Note: Please Note the speakers and topics were confirmed at the time of publication. However, circumstances may necessitate substitution, alteration or cancellation of speaker and / or topic, without prior notice
WHO SHOULD ATTEND?
- Analytical chemists and laboratory technicians in QC and R&D laboratories in pharmaceutical companies
- QA and RA personnel involved in auditing and reviewing analytical data
- Pharmacists and formulators who want to understand how to handle deviations in the pharmaceutical process
- Anyone who wants to be updated on the recent regulatory status and the current practice related to the issue of handling unexpected test results
- Management personnel who wants to understand why a batch of drug product might be rejected
Participation fees:
PDA members - 750 NIS
Non members - 950 NIS
 Registration is mandatory, please register here
For map please click here
Free parking is available inside Machon Ayalon
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