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OCRA - Corrective and Preventive Action (CAPA)
Monday 22 October 2018, 04:30pm - 08:00pm
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Contact Rob Fleming at This email address is being protected from spambots. You need JavaScript enabled to view it.

Orange County Regulatory Affairs Discussion Group (OCRA)

Invites You To an Evening Workshop 


Corrective and Preventive Action (CAPA)




Regulatory compliance requires establishment and maintenance of nonconformance and corrective and preventive action (CAPA) procedures. Central to an effective CAPA system is the identification of root causes of problems. CAPA has long been a leading cause of FDA 483s and warning letters.
Join us to learn how to setup a compliant CAPA system. 


2.5 Hours Towards Your RAC Recertification
All OCRA Meetings Qualify For Recertification Hours



Host: Vinay Goyal, Product Stewardship Project Engineer, Johnson & Johnson Vision

Program Managers and Moderators:
Chenyin Ou, Senior Scientist, Velox Biosystems
Fatima Naseer, MPharm, Pharmacist
Kandarp Shah, PhD, RAC, OCRA Education and Professional Development Chairperson

Invited Presenter: RaShaune Johnson, Senior QM/QC Manager, Carl Zeiss Meditec Production, LLC



Schedule of Presentations: 

4:30 - 5:15 pm            Registration, Networking and Refreshments 

5:15 - 6:00 pm            Introduction and CAPA Overview
                                    Speakers - Chenyin Ou, Fatima Naseer and Kandarp Shah 

6:00 - 7:00 pm            CAPA – Avoiding the CAPA Blackhole: Where has my QMS gone?
                                    Speaker – RaShaune Johnson 

7:00 - 8:00 pm            Hands On Workshop, Q&A
                                    Coordinator – RaShaune Johnson


Note: Webinar will be from 5:15 - 7pm


What is Corrective and Preventive Action (CAPA)? Is CAPA applicable to drugs, biologics or devices? Learn the fundamentals of CAPA and understand why CAPA is the number one reason for warning letters. Beyond fundamentals, various CAPA causes will be reviewed along with how to determine and when to initiate a CAPA. The discussion will answer many common questions: Why are there so many CAPAs? How to get the other groups in the organization involved? Does it really cost less to be “proactive”? The discussion will explain how to define your CAPA program and know a robust QMS when you create it.

Download the OCRA 10-22-18 Meeting Flyer for more details, registration form and driving directions.


Cost to Attend:

OCRA Members: $75 

Non Members: $150 (includes OCRA Membership for one year) 

Government and Students: $35 

FREE for Johnson & Johnson Vision Employees (please email Rob Fleming (This email address is being protected from spambots. You need JavaScript enabled to view it.) to be added to the list)

Location Johnson & Johnson Vision (formerly AMO) 1700 E St Andrew Place, Santa Ana, CA 92705
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