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

 

 

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