Understanding good Closed Loop CAPA system

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.

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Understanding good Closed Loop CAPA system

Understanding good Closed Loop CAPA system

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Instructor : Bernice Russell Bond

Product Id : 600151

Overview: Increased regulatory pressures, the latest customer mandates and internal quality initiatives are requiring companies to take a proactive and automated approach to their corrective action process.

In addition, regulatory compliance requires organizations to capture all corrective action issues and track their corrective action process to completion.

This webinar will present how organizations can pursue continual improvements and address the concerns of non-conformances and develop corrective/preventive actions to prevent the repetition of these occurrences in the future.

Areas Covered in the Session:

Importance of CAPA Process
Roles within the CAPA Process
Elements of a Closed Loop CAPA process
Importance of Risk Analysis Process
What needs to be in place for Compliance
Software Solution Requirements

Who Will Benefit:

Quality Assurance Personnel
Business Process Owners
Compliance Personnel
Regulatory Personnel
Internal Auditors

As President of BRUSSELL Consulting, Inc (BCI), Bernice brings over fifteen years of business operations, risk management, audit and compliance experience. She has worked for business, legal, audit, and IT management groups within various industries including manufacturing, financial and pharmaceutical. She has acquired practical insights, exposure to leading compliance practices, and seasoned judgment based on her work supporting the Compliance and IT Groups of Global Companies. In addition to her experience, Bernice also has the following academic credentials: B.S. in Accounting from Hampton University and an M.B.A with an emphasis in Technology Management from the University of Phoenix.

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