PDA Seminar

Systematic approach for
Corrective & Preventive Action

13 June 2011
Lev Hakongressim, Weizmann Science Park, Ness Ziona

Organized by Eitan Gross

The basic CAPA procedure should clearly define the fundamental elements for developing CAPA files which address significant quality system non-conformances (e.g., safety and product quality issues), including: immediate actions, root cause analysis methods, implementation of corrective and preventive actions, verification of corrective and preventive actions, effectiveness monitoring and closure. The elements of the CAPA system must meet current regulatory requirements. CAPA files should be maintained by the CAPA owner while in progress, and then stored for future reference in a permanent filing system. This seminar intend to supply its audience clear and update picture on broad aspect of this important cost/effective impact issue which is under tight enforcement by regulatory bodies.





09:00 – 09:15
Opening Remarks
Moti Izhar
PDA Israel Chapter President
09:15 -  10:00
Global Harmonization Task Force FDA approach on CAPA
Eitan Gross
Medimop Medical Projects
10:00 – 10:45
OOS/deviation Handling general
Eli Schmell
10:45 – 11:15
Coffee Break
11:15 – 12:00
Review of recent FDA warning letters in regards to CAPA
Judah Lando
Lando Quality Management
12:00 – 12:45
Trending of Microbiological OOS data
Karen Ginsbury
12:45 – 14:00
14:00 – 14:30
Statistical Methods for trend analysis
Raphy Bar
BR Consulting
14:30 - 15:00
Root Cause Investigation Methods – Theory & case studies
Ayala Cost
Chemagis - Perigo
15:00 – 15:30
Coffee Break
15:30 – 16:00
CAPA management using computerized system
Gilad Kigel
Sparta systems
16:00 – 16:30
Panel discussion
Seminar Speakers

Who should attend?

  • Production /Laboratories /Quality control personnel who involved with process evaluation and data analysis in pharmaceutical, biopharmaceutical and medical devices companies.
  • QA personnel involved in customer complaints handling, auditing, compliance issues.
  • Regulatory personnel who want to have deeper understanding of requirements/expectations of the regulatory bodies towards CAPA quality sub system.
  • Anyone who wants to be updated on the recent regulatory guides and the current practice related to the issue corrective and preventive action management.
Participation fees:
PDA members - 690 NIS
Non members - 885 NIS

Registration is mandatory, please register here
Organized & Produced by
Bioforum - Applied Knowledge Center
Lev Hakongressim, Weizmann Science Park
P.O.B. 4034 Ness Ziona, Israel, 70400
Tel: 08-9313070
Fax: 08-9313071
E-mail: bioforum@bioforum.co.il
site: www.bioforum.co.il