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