The US Food and Drug Administration Safety and Innovation Act (FDASIA) have authorized the FDA to collect manufacturing quality data from pharmaceutical organizations and obtain certain records from a drug manufacturer in lieu of, or before an inspection. Also the previously applicable two-year drug inspection frequency requirement is being replaced with a risk-based inspection approach.

Metrics programs ought to be a center piece of an organization's pharmaceutical quality system. This webinar will discuss on collecting, submitting and, most importantly, analyzing the data, drawing conclusions, and taking relevant and necessary actions to implement continual improvement projects.

Course Objectives:

• Understanding the USFDA's quality metrics program and its requirements
• ICH Q10, the pharmaceutical quality system
• The three quality metrics guidance's
• Data that will be required from the industry
• The meaning of each of the quality metrics
• Discuss the challenges of defining, collecting, and reporting a standardized set of quality metrics
• How the firm can proactively apply the concepts of quality metrics and the specific quality metrics that will be calculated by the FDA to support the concept of continuous improvement
• Challenges in meeting the FDA requirements for quality metrics

Why Should You Attend:

Each company tends to collect data in its own way for its own internal use, using a range of definitions and sampling plans. How firms measure and define "batch," "lot," and even "rejection" can differ among companies in different sectors, in the same sector, and even within the same company. Standardization is required to guarantee that the metrics reported to the FDA are defined and considered the same way by all.

This online course teaches the role of quality metrics within a company's Key Performance Indicator (KPI) program. The speaker Joy McElroy will discuss regarding potential regulatory metrics - what they might be, how they could be collected and used in this informative webinar.

Course Outline:

• Quality Metrics - Understanding and Requirements
• The evolution of quality metrics and quality systems
• Each of the metrics identified in the guidances
• Industry responses
• Data FDA will expect
• Calculation of the metrics
• Challenges for defining, collecting & reporting a set of quality metrics
• Interpretation of the metrics
• Suggestions on how the firm can use the metrics proactively
• Impact of the metric on the pharmaceutical firm

What You Get:

• Training Materials
• Live
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Purchasing
• Supply-chain management
• QA/QC
• Regulatory/compliance
• GMP/production
• Data analysis
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Manufacturing engineers
• Quality engineers
• Quality auditors
• Quality control personnel
• Document control specialists