Is it a Recall? Now what do we do?
Thursday, August 28, 2014
Noon – 5:30 pm
Orange County Regulatory Affairs Discussion Group (OCRA)
Location:
Irvine Marriott
18000 Von Karman
Irvine, CA 92612
949-553-0100
Program Managers:
Mugdha Dongre, Regulatory Affairs Specialist, Bausch + Lomb
James (Rusty) Lusk, Principal, Quality Systems International
Janet Rubin-Halpert, RAC, CQE, CBA, CQA
Speakers:
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
Synopsis:
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.
Agenda:
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
Break
4:05 – 5:00 pm
Case Study and Q&A
5:00 – 5:20 pm
Networking
Cost:
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.
