Featured Conference
CBI’s Annual Recalls Summit
Comprehensive Policies and Procedures for Ensuring Effective Recalls from Manufacturing to Wholesalers, End Users and Hospitals
September 17 – 18, 2007 * Arlington, VA
For more information or to register, please visit the conference website.
CLASS I DRUG RECALLS ON THE RISE
CDER performed 45 Class I recalls of human drugs deemed to have “very serious potential to cause harm, injury or death” in the last fiscal year [and]…the period from Oct. 1, 2005, to Sept. 30, 2006, also saw 193 Class II recalls of drugs deemed “to have the potential to cause harm,” but where the damage is reversible, and 128 Class III recalls, which are generally for labeling violations and do not pose a direct health hazard
– FDA News Daily Bulletin
Planning for, and navigating through, a product recall is an enormous concern for drug, device and biotech companies. Daily reports of potential recalls or market withdrawals for common prescription and OTC drugs flood the public domain, proving that even industry giants are subject to a recall. A product recall is potentially detrimental to a company’s image causing lost opportunity costs as well as the direct costs from performing the actual recall. Ensuring that everyone, from management to marketing to customer service to quality and regulatory, is aware of the recall strategy is vital to a company’s preparedness. This is the only conference that provides a platform for the industry to discuss critical topics. Industry leaders reconvene in 2007 to discuss:
- What happens when your recall is audited by a regulatory agency?
- Third party contract manufacturer relations during a recall
- Field actions
- Benchmarking mock recalls
- NPA field alerts & BPDR’s as related to recall decisions
- Repackers & recalls
- Recalls of API’s
- Timelines of recall return processing
- Chain drug policies & practices
- Effective & ineffective recalls
Hear what some of our previous attendees had to say:
“This conference provided in-depth coverage of many different aspects of the recall process.”
– Jennifer Rugger, Senior Quality Assurance Representative, Eli Lilly
“ Very informative seminar. If you are responsible for recalls you need to attend this seminar!”
– Beth Crews, Associate Director Recalls Compliance, Wyeth
“I come from a wholesaler background and it was very helpful to get a more rounded complete picture of the process from the manufacturing perspective.”
– Donna Dormer, Recall Coordinator, AmerisourceBergeon
“ Great to have everyone in the process together in one forum!”
– Brandy Fourmet, Product Integrity leader, PSS World Med
“The presentations covered all aspects of the recall process from many different perspectives. Anyone/everyone involved in this process would benefit.”
– Terri Magee, Director QC, Medicis
“This recall conference allowed me to gain insight into how other players in the recall process are affected.”
– Alicia Capuga, Product Compliance Analyst, AstraZeneca
“The largest value to me was to benchmark how the recall coordinator operates at other manufacturers and distributors, and the others relationships with FDA hierarchy.”
– Hal Baden, Recall Coordinator, Cordis
For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com or visit the conference website.
