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CAPA for FDA Regulated Industry |
| Identifying and Resolving Common Bottlenecks and Productivity Issues in CAPA Management |
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A robust Corrective and Preventive Action (CAPA) program is of utmost importance to the FDA regulated industries. Implementation of a systematic and consistent CAPA process helps to investigate, identify and eliminate nonconformances, which in turn ensures regulatory compliance and cost savings.
MetricStream provides a comprehensive non-conformance and CAPA software solution that enables companies to streamline their Nonconformance and CAPA processes across the enterprise. The solution supports identification, evaluation, segregation and disposition of nonconforming material as well as case investigation and tracking, and in this way, helps to form a sound CAPA program.
Areas Covered in the webinar:
- CAPA elements
- Accelerated CAPA investigation, approval, and closure with automated workflows
- Independent processes for containment, corrective, and preventive actions
- Improved communication and teamwork with parallel and sequential activities
- Real-time reports and dashboards for the CAPA process metrics and analytics
| Panelists |
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Jeff Kasoff - Director of Regulatory Affairs, Life-Tech, Inc
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies.
Ramesh Srinivasan
Manager- FDA Risk Management Solutions, MetricStream |
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