Notification Tactics for Improved Notification Tactics For Improved Field Action Communications
1. Notification Tactics for ImprovedNotification Tactics for Improved
Field Action Communications
L. Tussing
June 2013
2. 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.
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L. Tussing
June 2013
3. 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 communication
Strategies for obtaining and documenting information
Communication strategies
o Internally
o Externally
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L. Tussing
June 2013
4. 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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June 2013
5. 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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June 2013
6. 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
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Document delivery/receipt of the communication
L. Tussing
June 2013
7. Internal Notifications
• Public Affairs
• Customer Care• Customer Care
• Medical
• Investor Relations
• Insurance
• Marketing/Sales/Reps
• International
• Production
• Website
• Finance
Oth
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June 2013
• Others
8. 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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L. Tussing
June 2013