Live Webinar
Effective & Essential CAPA process to avoid FDA 483
Overview:
How do you prevent becoming another FDA statistic? Poor
corrective and preventive action (CA/PA) and investigations
continue to be among top FDA Form 483 deficiencies issued to drug,
biologic, and medical device manufacturers. It's in everyone's self
interest to improve the quality of investigations and CA/PA. This
webinar will provide regulated companies the core principles and
practices needed to implement an effective and efficient CA/PA
process.
This presentation will begin by defining risk in compliance and the
methods, which can be used to mitigate risk. One of the methods
defined by the regulators and the industry is "Corrective Action /
Preventive Action" otherwise referred to CA/PA. We will first define
what we mean by risk. We will then explore the factors associated
with risk in compliance. We will also explore risk causing events and
how to address them. A review of risk severity/level will then
ensue. Upon completion of risk part of the presentation we will
define what a CA/PA system would look like.
Areas Covered in the Session:
l FDA Inspection trends related to CA/PA
l CAPA data sources
l Elements of a successful CA/PA system
l Integrating risk management
l How to document
l How to Investigate and determine severity
l How and what to track - lifecycle management
Click here to register for this webinar
Who Will Benefit:
l Technical Services
l Manufacturing and packaging
l Engineering
l Facilities Services and Maintenance
l Validation
l QA/QC
Date:
Wednesday, September 08, 2010
Time:
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Price:
$245.00
Register Now
Instructor Profile:
Nancy is the Director of Quality &
Regulatory Affairs, Healthcare
responsible for global coordination of
Celestica’s Healthcare Quality,
Regulatory and FDA compliance.
Nancy is Quality and Regulatory
expert with fifteen years experience
in regulatory affairs, quality
systems, compliance, clinical qualit