Standard Operating Procedures ,Title 21,Title 493, 2012 - Last Chance to Register on Effective Root Cause Analysis and CAPA Program By compliance2go

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)