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Effective Root Cause Analysis and CAPA Program

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




                                             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,
Get 15 % Discount as a early bird             the stagnant economy, ever increasing
registrations. Use Promo Key :                competition, a greater public awareness, and
 CGO15                                        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
Pricing                                       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
Live ( Single registration ) : $189.00        investigative process and a healthy CAPA
Group ( Max 10 Attendee): $249.00             system, successful organization are able to
On Demand (Recording available):$289          minimize their regulatory profiles and avoid
Get Training CD : $399                        costly recalls

                                            Areas Covered in the Session:
Who will benefit                           • Regulatory Requirements for CAPA
                                           • FDA Expectations
                                           • Benefits of an Effective CAPA program
Directors, Managers, professionals,        • Goals & Objectives of an Investigation
technicians and general staff with         • Investigation Strategies
responsibility for the following areas:    • Common Problems with Investigation Reports
                                           • Not every problem deserves a CAPA
Quality Assurance

Quality Control

Manufacturing and Maintenance.
                                               About Speaker
Regulatory Titles
                                           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).

                                           .

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

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posted:10/2/2012
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