This edition includes 80 pages of vital information on planning, implementation, meeting and exceeding required actions under Quality System Regulations.

The Special Edition: Corrective & Preventive Actions covers the following topics:

• The Old vs. the New: A Breakdown of the Corrective and Preventive Action Requirements in the New Quality System Regulation
• A Deeper Look at Corrective Action
• A Team Approach to Medical Device Failure Investigation and Resolution: A Case Study
• Failure Analysis & Corrective Action for an IV Catheter Component Problem: Case Study
• Beyond Compliance: Exceeding Requirements with Systematic Corrective Action
• Implementing Corrective Action: An Escalation Approach to Compliance and Business Value
• Corrective and Preventive Actions (CAPA): A Medical Device Case Study
• Implementing Corrective Actions for FDA Observations
• Non-Conformance, the Corrective and Preventive Action (CPA) Initiator
• Corrective and Preventive Action: Planning to Achieve Sustainable GMP Compliance
• Be SMART With Your Corrective and preventive Actions (CAPA) These articles have been provided by leading professionals, and compiled to assist you with a wide variety of corrective and preventive action issues.