Live webinar on Effective Root Cause Analysis and CAPA Program BY Compliance2go

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Live webinar on Effective Root Cause Analysis and CAPA Program BY Compliance2go

Website https://compliance2go.com/index.php?option=com_training&speakerkey=31&productKey=117 | Edit Freely

Category Training, web seminar,FDA,Japan,EU, pharmaceutical and biologic products, Life Science Industry, CE Marking, Medical Device R&D, Clinical research and medical operations

Deadline: June 28, 2012 | Date: June 28, 2012

Venue/Country: houston, U.S.A

Updated: 2012-05-26 02:43:52 (GMT+9)

Call For Papers - CFP

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, Founder and President of GMP TDC LLC, a training, development and consulting company that caters to pharmaceutical and biotechnology 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)

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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