Live webinar on Effective Root Cause Analysis and CAPA Program by compliance2go June 28, 2012

Live Webinar on : Effective Root Cause Analysis and CAPA Program
Tuesday, June 26, 2012 duration : 01:00 to 02:00 PM EDT





Get 15 % Discount as a early bird registrations. Use Promo Key : CGO15



Pricing

Live ( Single registration ) : $189.00
Group ( Max 10 Attendee): $249.00
On Demand (Recording available):$289
Get Training CD : $399

Who will benefit

Directors, Managers, professionals, technicians and general staff with responsibility for the following areas:

Quality Assurance

Quality Control

Manufacturing and Maintenance.

Regulatory Titles





Description
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
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

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).
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https://compliance2go.com/index.php?option=com_training&speakerkey=31&productKey=117

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