| Description |
As recalls are becoming commonplace for many regulated and non-regulated products, and the public awareness of them is increasing, the bio/pharmaceutical and medical device industries, along with the FDA, must work even harder to develop clear, executable procedures and communication channels to minimize risks to public health and public image. CBI’s Annual Bio/Pharmaceutical and Medical Device Product Recalls summit is the only forum where industry and Agency come together to discuss recall procedures, their expectations and how to improve on current processes.
Each year there is great progress made at this summit helping companies to increase compliancy, efficiency and the collaboration of manufacturers, distributors and end users in a recall situation. 2008 is looking to further build on this success with an agenda focused on preparedness, communications and execution of product recalls, as well as greater FDA involvement. A must-attend for anyone with responsibilities in planning for and/or executing a recall.
Benefits of attending include:
• Problem solve with the FDA to increase compliance and process understanding
• Build communication procedures throughout the recall supply chain
• Understand the requirements of medical device risk, classification and liability
• Partner with suppliers, distributors and retailers to develop an anti-counterfeiting strategy
• Roundtable sessions discussing recalls biggest challenges
• Navigate industry trends and their effects on product recalls
Plus Two Pre-conference Workshops:
A. Risk Management – Tactics to Facilitate Compliance and Reduce Ambiguity in Recall Decision Making
B. Effective CAPA Management Systems to Maintain Compliance While Increasing Investigation Accuracy and Efficiency
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