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Friday, April 13 • 8:00am - 5:00pm
Workshop 20 - General 201: Systems Thinking in Quality Management (1 day)*

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*Please note that this is the course that was formerly called "New Perspectives in QA."

RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

The course provides an opportunity for the QA auditor to learn about systems thinking, system dynamics and related areas and how that knowledge may enrich quality management and lead to a deeper understanding of the nature of QA. The intention of the course is to enhance the effectiveness of the QA auditor's own activities and interactions in QA with peers, colleagues and auditees and to develop and refine QA competence beyond the training of GXP regulatory requirements. The course will consist of short presentations/briefings and discussions, case studies, workshops and exercises where participants are invited to contribute. Participants must be able to communicate fluently in English.

At the end of the course, the participants shall be able to: 
  • Understand key features of systems thinking and how they are related to quality assurance
  • Have a selection of new tools and techniques for achieving quality outcomes and building an effective QA function in partnership with their organization
  • Identify activities that will provide the key to future professional and personal development

Target Audience
GXP professionals with some experience in QA (ideally 3 or more years), who wish to learn about new topics related to QA, in particular systems thinking tools and techniques, enhance professional and personal growth and their contribution towards a quality organization.

  • The Status Quo
  • Where are we in QA? What's our role?
  • What are the expectations?
  • What keeps us busy?
  • Broadening the Perspective: Systems Thinking and more
  • Key Features of Systems Thinking
  • Systems Thinking and Quality Management – how to combine?
  • More Ideas from Cybernetics, Psychology and Management
  • Putting the new Tools and Ideas to Use
  • Clarifying the Personal Vision
  • Understanding Mental Models
  • Building a Shared Vision
  • Learning as a Team
  • Engaging to add Value
  • The Learning Organization
  • New Roles for QA: Designer, Facilitator, Teacher, Coach
  • Creating a Quality Culture


Rita Hattemer-Apostel

CEO/ Consultant, Verdandi AG
Rita Hattemer-Apostel is an expert in Quality Management and Good Clinical Practice Quality Assurance. Since 1994, she has performed more than 700 audits worldwide in all clinical trial areas at sponsors, CROs, laboratories, technical service providers, clinical investigators and... Read More →
avatar for Anthony Jones

Anthony Jones

Executive Director Corporate Quality, Syneos Health
Tony Jones is Executive Director, Quality Assurance for Syneos Health where he has responsibility for QA within the company’s Early Phase operations. Tony has over 30 years of experience in the healthcare and pharmaceutical industries, encompassing clinical chemistry, pharmacokinetics... Read More →

Friday April 13, 2018 8:00am - 5:00pm PDT
Platinum 7