AGXPE West Coast Chapter Spring 2021 Meeting

AGXPE West Coast Chapter Spring 2021 Meeting

Hello, as this event is free of charge all AGXPE West members have been automatically enrolled.  Feel free to attend if you would like to.  Future events will not employ the auto-enroll feature as there will be a cost associated.  -Chris O'Leary, President AGXPE West

Theme:  Quality & Automation

Cost:  FREE! (future meetings $29 per attendee)

NOTE:  AGXPE West has an open leadership opportunity!  We are recruiting for Treasurer.

Two topics for this event, please scroll down to see the details of both topics!

LOG IN DETAILS:

Thursday, May 6 - 1:00 – 2:30pm (PDT)

Thursday, May 6 - 4:00 - 5:30pm (EDT)

Google Meet joining info

Video call link: https://meet.google.com/nua-kbce-jth

Or dial: ‪(US) +1 929-276-0049‬ PIN: ‪645 924‬#

More phone numbers: https://tel.meet/nua-kbce-jth?pin=1117774185583

Topic 1:  Pharma 4.0” needs “Operator 4.0

• Speaker:  Patrick Boyle,  President, Skillpad Canada Inc.
• Bio:  

  Patrick Boyle served in the Canadian Air Force for 13 years, with two active duty tours flying jets in Training and Combat Support roles.  He then joined a major aircraft manufacturer in Montreal, and spent the next 15 years as an instructor pilot, check pilot (examiner/inspector) and test pilot, with the final 3 years as Manager of a Flight Test Center in an aircraft production facility.  During that time, Patrick designed and certified aircraft pilot training programs where complex technology, automation and human factors had to be combined for effective and safe operations. 

  In 2014, Patrick joined Skillpad, a leading Life Sciences Knowledge Management company, and began adapting many of the Aerospace Industry’s proven approaches for human performance in Automation Management and Situational Awareness to the challenge of training Pharmaceutical and Biotech plant employees for the realities of working in highly automated manufacturing environments, where integrated and interdependent systems are being deployed, requiring error-free performance from all those working with them.

• Automated, inter-connected and interdependent technology systems are rapidly becoming the new normal as the Biotech and Pharma Industries move into the “4.0” era.  While technology improvements tend to take center-stage, and command the budgets for large-scale projects launched from the corporate level, there is one all-important element that must not be forgotten:

·         Companies will need highly-qualified operators to run these new systems. 

• The role of the operator will change, and there may even be less humans in the Human-Machine Interface (HMI) control loop, but system designers will need to think of operators as contributors and participants rather than mere system monitors ‘where the Automation, Machine Learning, and AI does all the work’. 
• The human operator will need to become “Operator 4.0” in order to work effectively in “Pharma 4.0” – and the starting point for the ‘upgrade’ of our operators will be how we approach their training with a new mindset designed to interact with data, information and knowledge within complex technology systems.
• Drawn from parallels to flight crew training in the military and civil aviation and aerospace industries, where highly-automated Human-Machine Interfaces have been evolving for more than 25 years with “4.0”-style system designs, this presentation will give Biotech and Pharma professionals an original perspective on the connections between data, information, and knowledge that will form a core component of understanding, and optimizing, human performance in automated cyber-physical systems. 

Topic 2: 

Compliance Architects’ Quality Pulse® Quality Culture Diagnostic 

• Speaker:    Jamie Richter, Managing Partner - Compliance Architects LLC
• Bio: 

  Jamie Richter joined Compliance Architects as a Managing Partner, following 25+ years in health care, and leads various initiatives to drive continued growth of the firm while sustaining historical best-in-class customer outcomes. Mr. Richter began his career consulting to the life sciences sector at The Wilkerson Group and has since held executive roles, spanning high-growth start-ups to Fortune 500 companies. His positions have included Sr. VP of the FDA Middle-Market Division at EduNeering, a leading provider of online compliance training services; Commercial VP of a start-up operating company within the J&J Diabetes Care Franchise; Corporate VP of Operations at CardioNet, whose novel, real-time outpatient cardiac monitoring device revolutionized arrhythmia diagnosis; and VP of Business Development at ReMed, a leader in the field of Traumatic Brain Injury rehabilitation.

  Jamie earned an M.B.A. with a major in Health Care Management from The Wharton School of the University of Pennsylvania and a B.A. in Psychology with Honors from Brown University.

• Synopsis:  

  Establishing and maintaining a superior quality culture is critical for long-term success of life sciences companies in today’s competitive environment.  Furthermore, it mitigates key business risks, thereby protecting not only a company’s brand and reputation, but also its executives, investors, and the very consumers it serves.  The proprietary Quality Pulse® quality culture diagnostic, a breakthrough tool developed and refined for over a decade to incorporate state-of-the-art technology, extensive and flexible metadata analysis, and the latest scientific research, has been specifically designed for life sciences companies.  It redefines how such organizations assess and understand their own internal quality culture, elucidating highlights and notable challenges with the status quo.  Perhaps most importantly, Quality Pulse® reporting delivers specific, actionable intelligence to direct improvement programs and drive better quality outcomes and organizational excellence.  Please join us to learn why life sciences organizations of all sizes, including some of the world’s largest corporations, are accessing this unique and practical resource.

We welcome you to join is for two very interesting topics!

-Chris O'Leary

President, AGXPE West

650-438-7120