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A Science and Risk-based Approach for Quality Systems Operations

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You Can’t Distance From Quality

 

Pharmaceutical manufacturing companies are essential businesses in the current global environment of pandemic response; the products supplied are critical to the care and wellbeing of patients around the world. Continuing to operate in a controlled manner, following their Quality Systems, and producing safe and effective products are a significant challenge with an unexpected illness, quarantine response, distancing, and travel restrictions. We will discuss the areas which may expect challenges, sound engineering and science-based responses, and communication approaches to navigate this challenging regulatory and quality environment.

 

Top Reasons to Attend

 

  • Discuss possible impacts to plant operations
  • Discuss approaches to coping with impact to testing, maintenance, and calibration schedules
  • Gain a deeper understanding of Quality Risk Management and application case study
  • Discuss best practice guidance from ASTM, ISPE, and PDA
  • Review the science and engineering basis behind quality requirements
  • Successfully work with suppliers during limited visitation
  • Engage employees remotely
  • Receive tips on maintaining production
  • Return to normal operations
  • Improve quality operations for the long term

 

 

Speakers

David Shenberger

CAI, Vice President - Western United States and Puerto Rico

David Shenberger is the Vice President, Western United States and Puerto Rico responsible for business development and project execution in the Western US and Puerto Rico at CAI. He has an Executive Certificate in the Business of Life Sciences from Indiana University and a BS in Technical Management. David has over 25 years’ experience in project management including a PMP certification and has extensive experience leading large automation qualification and computer system validation projects. He has spoken on validation project management and execution and is a member of ISPE and SMPS.