Quality Metrics and Quality Culture for Pharmaceutical Manufacturing - Australia

Melbourne, Australia
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Participants will examine their quality management system, select the appropriate quality metrics that drive intended behaviors, and determine how best to collect and use the data to improve the quality system using the ICH Q10 guidance as framework for a practical and suitable methodology. Topics will also include how to conduct effective quality management reviews.

Participants will then compare and contrast application of quality metrics to drive and enhance the quality culture, including measuring their company’s current quality culture and formulating an action plan to transform the quality culture.

Who Should Attend

This course is for quality and manufacturing management responsible for the continuous improvement of the quality system (QS).

More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Identify appropriate quality metrics that drive intended behaviors and promote continuous improvement
  • Collect and analyze quality metrics data to communicate quality culture and drive actions and decisions to improve the quality system
  • Describe the desired quality culture for your company
  • Utilize tools to measure the current quality culture
  • Develop an action plan for transforming your company’s quality culture

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David B. Talmage, Senior Director, Education, PDA

With over 15 years in the pharmaceutical, biopharmaceutical and consumer industries, David has expertise in the quality systems leading to extensive experience in all aspects of manufacturing, validation and inspection readiness, with a focus on process optimization and efficiency in resource utilization. His proficiencies include consent decree remediation efforts and management of quality systems, product tech transfer and rapid site growth training, pre-approval inspection readiness, commissioning and validation, and facility start-up.

David’s specializations include technical training and he currently serves as the Director of Education for the Parenteral Drug Association (PDA) where he is responsible for the development and delivery of PDA’s courses and the operation of the Training and Research Institute’s cleanroom and laboratories.

He has worked at Johnson & Johnson, MedImmune/AstraZeneca, Genzyme, Dendreon and Bayer HealthCare. David holds an MBA with a concentration on operations management and a BS in chemistry from Washington State University.