Enhancing Critical GMP Processes Using Performance Metrics

MessageThis Webinar is over
Date Nov 14, 2017
Time 01:00 PM EDT
Cost $250.00
This training program will discuss how to effectively create performance metrics and goals for your department or project. It will also discuss the key components of a metric and when to use different types of performance metrics. The outputs of process performance and product quality monitoring are the key for continual improvement. The necessary changes can be identified, introduced, monitored and controlled to continually improve processes and systems.

Objectives of the Presentation
  • How to define a metric
  • How to establish a SMART (Specific Measurable Accepted Realistic Time Bound) metric
  • Review different types of metrics
  • Discuss benefits and challenges of metrics
  • Adequate indicators to show compliance with regulations
Why Should you Attend
Many clients, internal and external, seek objective evidence of how systems/processes are functioning. Using a well-developed performance metrics system can answer those looming questions and remove the guessing games. In this session, the webinar instructor will focus on how to effectively create a performance metrics system that will focus on the critical work systems. The discussion will include a review of different types of performance metrics and when to consider using them.

The course will cover some of the potential pitfalls that people encounter with metrics and discuss how to avoid them from the start. Keep in mind there is no one size fits all metric to track every process.

Areas Covered
  • Quantitative vs. qualitative data
  • Discuss how to effectively create performance metrics and goals for your department or project
  • Discuss the key components of a metric
  • Discuss when to use different types of performance metrics
  • How to measure product specific/operational quality performance, the performance of the overall quality system and quality culture
  • Discuss setting up a successful metrics program including some helpful tips to consider
  • Adequate indicators to show compliance with regulations
Who will Benefit
  • Project Managers
  • Quality Assurance/Quality Control Managers/Directors
  • Process Improvement Professionals
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Engineering and design controls teams
  • Executive management
  • General/corporate counsel
  • Managers
  • Manufacturing directors and supervisors
  • Medical/technical writers
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • R&D staff
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Training personnel
  • Validation specialists, scientists, engineers
Topic Background
Quality Metrics have already been used in pharmaceutical industry for years - mainly internally to measure operational performance. But quality can be measured on different levels and for many processes. Done in the right way, Quality Metrics can enable companies to reach a high quality performance. They will benefit from a continuous improvement in both operational performance and GMP compliance. And both are important for the continuity of business and product supply.

Instructor Profile:
Dr. Susan Leister serves as the director of quality assurance at Technical Resources International Inc. with over 20 years of experience in the pharmaceutical and medical device industry. She has validated over 40 software systems in the past few years and is very fluent in software validation requirements and compliance. She is also faculty for both graduate and undergraduate studies at the University of Phoenix. In addition to a bachelor's degree in biochemistry and molecular biology, she has an MBA, a doctorate in organizational management with a focus on leadership, and holds certifications from the American Society of Quality (ASQ) as a Certified Quality Auditor and a Six Sigma Black Belt.Dr. Leister has broad experience in GCP, GLP, and cGMP. She serves the ASQ Section 509 Executive Committee as the chair-elect and has been serving for the past four years as a Maryland Performance Excellence Award Examiner. 


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