System Effective 2015 - Is your System Effective? Does your CAPA System Work for your Organization?

This training program will focus on why CAPA (corrective and preventive actions) remains one of the most frequently cited quality subsystems cited by FDA for violations during routine inspection. Attendees will learn how to make an organization’s CAPA system work for them instead of it landing them in hot water.
Why Should You Attend:
Each manufacturer is required to establish and maintain procedures for implementing corrective and preventive actions. CAPA is inherently linked with other quality system elements such as complaints, internal audits, documentation practices, employee training, and nonconforming materials. The objective of 21CFR §820.100 is to correct and prevent poor practices rather than simply bad product. Correction and prevention of noncompliant or unacceptable quality system practices should result in fewer product nonconformities.
This webinar will offer background, definitions and FDA CAPA inspection citation statistics. The course will further review 21 CFR 820.100 and other related regulations as well.
Areas Covered in the Webinar:
Background
Definitions
FDA CAPA inspection citation statistics
Review of 21 CFR 820.100
Related regulations
Elements of an effective CAPA process
How to remediate if your system is not effective
References
Questions/Answers
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Regulatory or quality assurance management
Project managers or staff involved in the CAPA process
Manufacturing and development management involved with CAPA process
Instructor Profile:
Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. She is currently the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in quality, regulatory, clinical and compliance in the medical device and pharmaceutical industries.
Ms. Wagoner is a member of Regulatory Affairs Professionals (RAPS) and Medical Device Manufacturers (MDMA) FDA Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management.
For Registration - http://www.complianceonline.com/is-your-capa-syste...
Note: Use coupon code 232082 and get 10% off on registration.