Date : Wednesday, July 5, 2011
Time : 10:00 AM PDT | 01:00 PM EDT Live Webinar
Developing an Effective CAPA Strategy
Duration : 60 Minutes
through Root Cause Analysis of Failures &
Price : $245.00 Deviations
Inadequate failure investigations continue to be a major GMP
deficiency cited during routine and for-cause regulatory
inspections. This webinar highlights FDA and EU regulations Instructor Profile:
and how to successfully approach a failure investigation and
engage in subsequent root cause analysis.
Director, Quality and
Regulatory Affairs, Celestica
Learning Objectives: Nancy,is the Director of Quality &
This course provides clarification of regulatory expectations Regulatory Affairs, Healthcare
and guidance, and the essential skills necessary to ensure responsible for global coordination of
effective and efficient investigations. Topics will examine each Celestica's Healthcare Quality,
step of the investigation process from failure identification Regulatory and FDA compliance.
and notification through documentation.
Nancy is Quality and Regulatory
expert with fifteen years experience
Attendees will gain a perspective of effective interviewing and in regulatory affairs, quality systems,
writing skills, discuss common pitfalls, and develop tips and compliance, clinical quality,
techniques for thorough investigations and elimination of validation, auditing, quality control,
recurring failures and deviations. data management systems, post
market surveillance, supplier
Click here to register for this webinar management and regulatory
compliance in the areas of
Who Will Benefit: bio/pharmaceuticals, medical devices
This course is designed for personnel who are responsible for and combination products. ...more
the failure and deviation investigation process in a GMP
environment, specifically Root Cause Analysis for CAPA. These
include, but are not limited to, positions in Manufacturing and ISO 13485 Gap Analysis Toolkit
Packaging, Quality Assurance/Quality Control, and those
support groups who initiate, conduct and/or manage ISO 13485 Quality Manual
investigations in a pharmaceutical, clinical manufacturing, Intro to ISO 13485 Presentation
biologics and medical device environment. Materials
ISO 13485 Internal Auditor Checklist
Your Necessity is our Priority
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit
from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
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