Managing Product Recalls in Accordance with Part 806 2014

Topics

• Understanding the different types of field actions:
• 21 CFR, Part 806 compliance requirements
• Stock recovery
• Market withdraw
• Classification of Recalls
• Correction
• The recall notification process
• Creating an effective Recall Packet
• Recovery and quarantine of product
• Reporting recall-related activities to the FDA (required reports)
• Formal closeout of a recall, including the FDA notification process
• Disposition of recalled product (certified destruction or rework)

Who should Attend

• Regulatory Professionals
• Quality Professionals
• Customer Service Professionals