Performing Effective Management Review of the Quality System

This webinar will teach you how to conduct an effective management review of the quality system which helps you understand how to plan and focus on right metrics and governed by an efficient process. Participants will also understand FDA policy regarding disclosure of management review information during inspections.

Why Should You Attend:

Under FDA regulations, Medical device companies are required to perform at least an annual review of the quality system. Pharmaceutical companies are not required but are 'expected' to do so in the U.S., and are required under certain non-US countries’ regulations. In addition, guidance documents from the FDA and industry groups encourage management review.

Management review can be burdensome and difficult if not planned to focus on the right metrics, and governed by an efficient process. This webinar explores a successful approach to the performance of management review that yields a value added result and helps gain the buy-in of the executive level whose support is needed.

Learning Objectives:

• Understand the purpose of management review
• Understand the regulatory requirement for management review
• Understand an effective process for conducting the review
• Understand documentation requirements
• Understand FDA policy regarding disclosure of management review information during inspections

Areas Covered in the Webinar:

• Regulatory requirements for management review
• Status of management review under US, European and Canadian GMP, US medical device QSR, and via ICH Guideline Q10
• Purpose of management review
• Process for an effective management review
• Documenting management review meetings
• FDA policy on access to management review documentation during inspections

Who Will Benefit:

• Quality Assurance managers
• Manufacturing managers
• Laboratory managers
• Regulatory Affairs managers
• Senior level executives