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Ensuring Adequate Process Implementation and Adherence in CAPA Systems



 
Our Price: $250.00

Product Code: WB-7039
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About the Product
Includes 1 hour and 30 minute Windows Media Video File and PowerPoint presentations for immediate download.


The FDA is heavily focused on enforcing Corrective and Preventive Action (CAPA) System requirements having recently cited numerous manufacturers for failure to maintain these practices. In today’s highly regulated environment, sufficient CAPA data and documentation processes that demonstrate product quality and safety are a top priority for quality teams; however, many continue to struggle with determining which issues should or should not be elevated to CAPA status. A recent industry study conducted by BSI reviewed FDA CAPA audits and found that quality departments often put too much emphasis on issues that don’t qualify for CAPA and ultimately struggle to focus on the “preventive” measures. In order to ensure product safety and effectiveness, it is critical for manufacturers to operate a CAPA system that will continuously monitor and improve quality throughout the product life cycle.
  • Strategic CAPA management on local and global levels
  • CAPA warning letter and violation trend analysis
  • Differentiating between corrections, corrective actions and preventive actions
  • Key considerations when evaluating CAPA tools

Speaker:
Lonnie Lassmann
Sr. Director, Global Quality Systems
KCI


Target Audience
  • Quality Assurance/ Quality Systems
  • CAPA Managers
  • Quality & Compliance
  • Manufacturing & Operations
  • Regulatory

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