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CAPA Case Studies (4B)

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Tuesday, 5 June 2012, 15.15 – 17.00

Moderator: Rick Friedman, Associate Director for Risk-Science Intelligence and Prioritization, OMPQ, OC, CDER, FDA, USA

The corrective action and preventive action (CAPA) program is an important part of a quality system. CAPA requires commitment throughout an organization to surface significant issues, and prevent conditions or practices that can ultimately lead to serious quality problems. Strong investigation procedures and qualified staff are needed to identify root causes and define actions to address emerging or existing problems. In some cases, inspections have found recurring drug quality issues were not adequately remedied by a firm's CAPA system. The value of an effective CAPA system will be explored in this session and illustrative case studies from both industry and regulators will be presented.

At the conclusion of this session participants will be able to:

  • Understand the role of the CAPA program in supporting maintenance of a state of control throughout the lifecycle
  • Understand the use of CAPA by the production and quality units

Session Agenda 

15.15 – 17.00
CAPA: Case Studies
Session Moderator:
Rick Friedman, Associate Director for Risk Science Intelligence and Prioritization, OMPQ, OC, CDER, FDA

15.15 -15.45
Recent Regulatory Findings Related to CAPA
Carmelo Rosa, FDA

15.45 -16.30
Industry Sharing Experiences and How it Can Benefit You - Improvement Studies
Bob Kiss, PhD, Director Process R&D, Genentech

16.30 - 17.00

Question and Answer

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