This presentation discusses the basics of product recalls and the proper method of communication between the different departments.

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

9. Thank YouThank You
L. Tussing
June 2013