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