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PDA Seminar
On
Systematic approach for
Corrective & Preventive Action
13 June 2011
9:00-16:30
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.
Program:
Duration
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Topic
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Speaker
|
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
BTG
|
10:45 – 11:15 |
Coffee Break |
| Chair |
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
PCI |
12:45 – 14:00 |
Lunch |
| Chair |
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 |
Chair |
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
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