August 18th, 2014

Is it a Recall? Now what do we do?

Thursday, August 28, 2014
Noon – 5:30 pm  

Orange County Regulatory Affairs Discussion Group (OCRA) 




Irvine Marriott

18000 Von Karman

Irvine, CA  92612



Program Managers:

Mugdha Dongre, Regulatory Affairs Specialist, Bausch + Lomb

James (Rusty) Lusk, Principal, Quality Systems International

Janet Rubin-Halpert, RAC, CQE, CBA, CQA



Phil Johnson, Sr. Director Regulatory & Quality EU, Quintiles Consulting

James (Rusty) Lusk, Principal, Quality Systems International

Denise McEachern, Consultant

Thanh Tran, District Recall Coordinator, FDA Los Angeles District



Many questions arise when complaints affecting the health of patients are received or design/manufacturing non-conformances are identified after product released to the market. Is the product required to be recalled or is it required to be corrected? Recalls have always been a vital part of the health industry. There are many ways to execute a recall. However, the most effective and efficient way needs to be employed.


This program will provide the nuts and bolts for implementing and managing an effective recall for all the major fields of the health industry such as drugs, biologics, medical devices, electronic and radiation devices, dietary supplements, and combination products. The session will also touch base on products involved in clinical trials along with methods to deal with unanticipated adverse effects. The session will walk you through the steps starting from identifying a recall and ending with effectiveness checks required to close the recall.


The session will close with case studies and a discussion panel, which will help the attendees to take away an effective plan/checklist to implement the recall process.






Noon – 12:45 pm

Registration, Networking and Light Buffet Lunch


12:45 – 1:30 pm

Identifying and Strategizing Recalls

James (Rusty) Lusk, Principal, Quality Systems International

This session will be focused on identifying whether it is a recall and follow through to its strategic planning for effective execution.


1:30 – 2:15 pm

FDA Requirements

Thanh Tran, District Recall Coordinator, FDA Los Angeles District

FDA requirements and what FDA wishes to see when a recall is initiated and during its compliance, inspection and close out. This session will also discuss the steps in the recall process and when industry should involve the FDA.


2:15 – 2:30 pm

Ice Cream Break


2:30 – 3:10 pm

Execution of a Recall

Denise McEachern, Consultant

We will discuss the initiation, internal inspection and compliance with FDA requirements and effectiveness checks for efficient close out of a recall. This session will also touch base upon the handling of a recall in the global market focusing on major markets like Australia, Canada, EU, Japan and US.


3:10 – 3:50 pm

Post Market Surveillance to prevent Recall

Phil Johnson, Sr. Director Regulatory & Quality EU, Quintiles Consulting

This session will walk through the steps one should take to reduce recalls in the industry and also talk on maintenance factors that should be considered throughout the product’s life cycle which could prevent recalls or Field Safety Notices.


3:50 – 4:05 pm



4:05 – 5:00 pm

Case Study and Q&A


5:00 – 5:20 pm





OCRA Members: $155

Non Members: $205

Government and Students: $75


Registration fee includes light lunch, beverages, ice cream break and parking. After the meeting, electronic access to the presentations will be made for all attendees. Dress code is business casual.


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