Features:

• Covers the latest developments on industry regulations

• Includes validation protocol templates

• Presents real life examples and case studies

• Provides a simplified explanation of how the process and regulation works

According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards.

Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file.

Contents

1. Introduction
   • What is Validation?

2. Package Design Validation
   • Elements of Package Design
   • Package Design Issues
   • Validation Flow Chart
   • Simulation Criteria
   • Qualified Suppliers
   • Tables 1-6

3. Package Process Validation
   • Introduction
   • Process Validation: What is It?
   • IQ, OQ, PQ
   • Process Capability Studies
   • Example: XYZ Medical Device Corporation: Validation Protocol-Process Capability Study

4. Putting it all Together: The Validation Protocol
   • The Validation File
   • File Maintenance
   • Employing the Process
   • Example: Package Validation File

5. Regulatory Activities
   • Selected Case Studies
   • Packaging Non-Compliances
   • Industry Generated Support Documents
   • HACCP-Furthering the Need for Package Validation

Appendix 1 Operations Manual (impulse Sealer)

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