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Aaron Weinstein

Compliance Manager

Validation Expert

Areas of Expertise

  • CQV Planning and Management of Large Scale Projects
  • CQV Activities Related to Biotechnology Facilities, Utilities and Equipment
  • Computer System Validation for ERP Systems

 

With the rapid change of technology, our clients must face the dual challenge of maintaining operations while keeping an eye on the future. I am happy when we are invited to join a project team and to help them implement new approaches to familiar issues.

- Aaron Weinstein
Compliance Manager

Aaron Weinstein possesses almost two decades of leadership and management experience in commissioning, qualification and validation of pharmaceutical, biopharmaceutical, laboratory and vivarium facilities, utilities and equipment.

Throughout his career, Aaron has directed CQV activities including development and implementation of both short-term and long-term commissioning, qualification and validation programs for projects ranging upwards of $250MM TIC. Aaron has provided CQV project planning and execution strategies (development of master plans, manpower estimates, schedules), technical and compliance consulting, development and implementation of computer system validation programs, cGMP audits and Part 11 assessments for a number of U.S. and multi-national companies around the world.

Aaron has recently provided the following presentations to share his expertise at the events noted:

  • "Computer System Validation for the Rest of Us", INTERPHEX 2015, New York, NY, April 2015
  • "Computer System Validation for the Rest of Us", INTERPHEX 2015, New York, NY, April 2015
  • “Calculating Odds of Success: A Workshop on Project Management (Making a Remediation Project Work: Knowing How to Beat the Odds)”, ISPE Annual Meeting, Las Vegas, NV, October 2014
  • p. 888.366.7660

Recent Projects

  • Laboratory Equipment Validation
  • CSV Framework and ERP Validation
  • CQV Planning and Implementation for a Single Use Biotechnology Facility
  • Medical Device Manufacturing Facility Commissioning