Notification Tactics for Improved Notification Tactics For Improved Field Action Communications
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Transcript of Notification Tactics for Improved Notification Tactics For Improved Field Action Communications
Notification Tactics for ImprovedNotification Tactics for Improved Field Action Communications
L. TussingJune 2013
Disclaimer
• The information in this presentation is representative of the Author’s experience and opinion and does not necessarilyAuthor s experience and opinion and does not necessarily that of Hospira, Inc.
2L. TussingJune 2013
Objectives
This presentation will cover the key elements of:Wh t d t b d i fi ld ti i tiWhat needs to be covered in your field action communicationStrategies for obtaining and documenting informationCommunication strategies
o Internallyo Externally
3L. TussingJune 2013
References and Guidance Documents
• 21 CFR part 7)
• 21 CFR 314.81(b)(1)
• 21CFR 806
I d t G id I f ti R ll f FDA• Industry Guidance - Information on Recalls of FDA Regulated Products
– FDA Guidance for Industry: Product Recalls Including– FDA Guidance for Industry: Product Recalls Including Removals and Corrections
– Model press releases and letters
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Contents of Communication• Heading / Type of communication• Identification of productp• Issue / Description of problem / Reason for action• Product description / Use
Hazard / Risk to user patient caregiver etc• Hazard / Risk to user, patient, caregiver etc.• Level of action if known• User actions• Distribution information• Alternate product
Company actions• Company actions• Timing• Communication / contact information
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Methods of Communication• Press Release• Traceable DeliveryTraceable Delivery
– mail / delivery service (FedEx, UPS) / telegram / email• Phone callo e ca• Rep visits• Website• Safety Organizations
Customer base will help determine how to best communication
Document delivery/receipt of the communication
6
Document delivery/receipt of the communicationL. TussingJune 2013
Internal Notifications
• Public Affairs• Customer Care• Customer Care• Medical• Investor Relations• Insurance• Marketing/Sales/Reps• International• Production• Website• Finance
Oth
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• Others
External Notifications
• Customers (direct and indirect)•HospitalHospital•Pharmacy•Wholesaler/Distributor/Buying Groups•Kitpacker•Compounder
• Service Providers• Service Providers• Safety Organizations• FDA/Regulatory AgenciesFDA/Regulatory Agencies• Others
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Thank YouThank You
L. TussingJune 2013