The document presents strategies for effective field action communications, focusing on key elements such as internal and external communication methods and the structure of notifications. It outlines the necessary content for communication, including product identification, issue descriptions, risk assessments, and user actions. Additionally, it emphasizes the importance of various communication delivery methods to ensure proper notification to relevant stakeholders.

1. Notification Tactics for ImprovedNotification Tactics for Improved
Field Action Communications
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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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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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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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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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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
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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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• 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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9. Thank YouThank You
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June 2013