Invitation to a
One-Day Seminar
on
QC Laboratory
in the
Pharmaceutical Industry:
Current Topics

Organized by Ms. Yael Brenner - Teva

Thursday, November 4, 2010, Kfar Hamaccabiah Ramat Gan

SEMINAR PROGRAM

Duration	Topic	Speaker
09:00 � 09:15	Registration
09:15 � 09:30	Opening Remarks by the PDA President	Dr. Moti Izhar President of PDA Chapter
09:30 � 10:00	GMP hot topics in the QC laboratory	Karen Ginsbury PCI
10:00 � 10:30	Qualification of contract laboratories	Dr. Rachel Karpel PCI
10:30 - 11:00	Contract laboratories – from the point of view of the contractor	Dr. Haim Schlesinger Analyst Research Laboratories
11:00 � 11:30	*Coffee Break*
11:30 � 12:00	Handling out-of-specification results	Alexander Nezlin Nextar
12:00 � 12:30	Stability samples testing: Difference between release and stability tests and OOS during stability	Micki Kadosh Taro
12:30 � 13:30	*Lunch*
13:30 � 14:00	Analytical standards	Anna Klempner Chemagis
14:00 – 14:45	Technology transfer of Analytical methods	Bat Sheva Arama Teva-KS
14:45 – 15:15	*Coffee Break*
15:15 – 15:45	Equivalence testing of two methods: The FDA recommended way!	Dr. Raphy Bar BR Consulting
15:45 � 16:15	Going towards a paperless QC laboratory	Chaim Vazana Teva API
16:15 – 16:45	Panel Discussion	Speakers and Mrs. Sarah Covrigaro (QA Manager and Lab Inspector, MOH)

Target Audience:

Analytical chemists and laboratory technicians in QC and R&D laboratories in pharmaceutical and biopharmaceutical companies, who test drug substances (APIs) and products
QA and RA personnel involved in auditing and reviewing analytical data.
Companies who wish to outsource analytical work to a contract laboratory
Pharmacists and formulators who want to understand how results are generated in a QC lab.
Anyone who wants to be updated on the recent regulatory guides and the current practice related to QC testing of drug substances and products.

Participation fees:
PDA members - 690 NIS
Non members - 885 NIS

Registration is mandatory, please register here