Notification Tactics for Improved Notification Tactics For Improved Field Action Communications
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Notification Tactics for Improved Notification Tactics For Improved Field Action Communications

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

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

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Notification Tactics for Improved Notification Tactics For Improved Field Action Communications Notification Tactics for Improved Notification Tactics For Improved Field Action Communications Presentation Transcript

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