102 - Human Error, Doing Quality Differently, Defining Accountability, Written Human Guidance, Blue Line vs. Black Line and Categorizing Deviations with Amy Wilson and Cliff Berry

Combinate Podcast - Combining Drugs and Devices

On this episode, I was joined by ⁠Amy Wilson and Cliff Berry, authors of "Do Quality Differently: The Playbook for Creating More Success in Biopharma (or Any) Manufacturing".

Amy and Cliff walkthrough:

• Human Performance and Challenges
• Defining Accountability from a Quality World-View
• Good Written Human Guidance
• Automating Procedure and QMS Feedback
• Categorizing Deviations Appropriately
• Blue Line vs. Black Line: Work as Imagined vs. Work as Completed

Amy Wilson: Amy has more than 20 years of biopharma manufacturing experience, focusing on human & organizational performance, operational excellence, risk management and technical training. She has led a global integration of Human & Organizational Performance within biopharma manufacturing. Amy has a Ph.D. in Industrial Engineering from North Carolina State University.

Cliff Berry: Cliff has worked in the domain of Human & Organizational Performance for over 20 years. He has experience in commercial nuclear electric generation, electric transmission & distribution, gas distribution, nuclear plant systems controls hardware & software integration, and most recently in biopharma manufacturing since 2015 where his primary focus is on creating more quality success. Cliff has a M.S. in Occupational Ergonomics & Safety from the University of Massachusetts Lowell.