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* Today, more than ever, the need to investigate and track quality issues is critical for the biopharmaceutical industry. The pressures that organizations are facing come from variety of sources: the increasingly regulations, both domestic and international, the stagnant economy, ever increasing competition, a greater public awareness, and greater demand for high quality medicines. In view of these challenges, the need to effectively investigate and track non-conformances becomes crucial for the survival of any company. With a Today, more than ever, the need to investigate and track quality issues is critical for the biopharmaceutical industry. The pressures that organizations are facing come from variety of sources: the increasingly regulations, both domestic and international, the stagnant economy, ever increasing competition, a greater public awareness, and greater demand for high quality medicines. In view of these challenges, the need to effectively investigate and track non-conformances becomes crucial for the survival of any company. With an effective investigative process and a healthy CAPA system, successful organization are able to minimize their regulatory profiles and avoid costly recalls.
Why should you attend :
This webinar will highlight strategies to create a robust system of reporting and investigating deviations and other non-conforming events as part of an effective quality management system, as well as understand the regulatory requirements of corrective and preventive action system (CAPA)
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Areas Covered in the Session:
• Regulatory Requirements for CAPA
• FDA Expectations
• Benefits of an Effective CAPA program
• Goals & Objectives of an Investigation
• Investigation Strategies
• Common Problems with Investigation Reports
• Not every problem deserves a CAPA
Who will benefit: (Titles)
Directors, Managers, professionals, technicians and general staff with responsibility for the following areas:
Quality Assurance
Quality Control
Manufacturing and Maintenance.
Regulatory Titles
About Speaker
Henry Urbach is a Management Consultant with Oriel STAT-A-MATRIX, a leading training and consulting firm that caters to pharmaceutical, biotechnology and medical devices industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in Training, QA, and QC Microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of remediation , and developing an environmental monitoring training program. He is a dynamic speaker specializing in FDA and ICH compliance, quality systems, and aseptic and environmental monitoring techniques. Henry is a founder and President of GMP Training, Development and Consulting LLC (GMP TDC), a New York-based consulting organization serving Life Sciences industries. He is a Certified Quality Auditor (CQA). His technical education is further complemented by his BA degree in Biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP Training and Education Association (GMP TEA)
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