Aaron possesses more than 20 years of API and biotech CQV execution, project leadership and project management experience in commissioning, qualification and validation related to state-of-the-art biopharmaceutical development, and manufacturing facilities. His experience includes the development and implementation of both short- and long-term commissioning, qualification and validation programs for projects valued up to $250MM. Aaron has provided technical and compliance consulting services, developed CQV master plans, conducted CGMP audits, CFR 21 Part 11 assessments and implemented CQV project planning and execution strategies for a number of US and multi-national companies around the world.

Education

B.A. - Interdisciplinary Studies (Chemistry / Biology), Touro College

Professional Associations

International Society for Pharmaceutical Engineering (ISPE)
Parenteral Drug Association (PDA)

Publications

Weinstein, Aaron. “CAR-T Supply Chain: Challenging, Achievable, Realistic & Transformational.” ISPE Annual Meeting & Expo, 7 November 2018, Philadelphia, PA.
Weinstein, Aaron. “Realizing Benefits and Efficiencies from Quality Systems.” INTERPHEX, 21 March 2017, New York, NY.
Weinstein, Aaron. “Initial Planning and Overall Execution of Commissioning and Qualification on Pharma Projects.” HUG (Honeywell Users Group), 15 June 2017, Phoenix, AZ.
Weinstein, Aaron. “Environmental Monitoring in the Pharmaceutical Industry - Systems, Requirements & Considerations / Planning and Executing an Efficient Validation Effort for Pharmaceutical Capital Projects.” HUG (Honeywell Users Group), 12 June 2017, Phoenix, AZ.
Weinstein, Aaron. “The Future of Quality in Pharmaceuticals and Medical Devices: A Look Forward.” INTERPHEX, 23 March 2017, New York, NY.
Weinstein, Aaron. “Track & Trace/Serialization #1 & #2.” ISPE Annual Meeting & Expo, September 2016, Atlanta, GA.
Weinstein, Aaron. “Computer System Validation for the Rest of Us.” INTERPHEX, April 2015, New York, NY.
Weinstein, Aaron, et al. “Bringing Life Sciences to the Cloud.” Cornerstone On Demand, June 2014.
Weinstein, Aaron. “Don't Gamble Your Project Away: Real World Lessons of Project Management Top Ten Lessons Learned: A Study in Project Management (A Strategy for Remediation Under Consent Decree: Management, Project Controls and Deliverables Related To These Challenging Projects).” ISPE Annual Meeting & Expo, October 2014, Las Vegas, NV.
Weinstein, Aaron. “Calculating Odds of Success: A Workshop on Project Management (Making a Remediation Project Work: Knowing How to Beat the Odds).” ISPE Annual Meeting & Expo, 13 October 2014, Las Vegas, NV.

Presentations

Weinstein, Aaron. “Improving Operations Through Efficiency.” Concurrent Session Leader. ISPE Annual Meeting, November 2021.
Weinstein, Aaron. “Computer and Systems Integrity Enablers for Cell & Gene Therapy.” INTERPHEXLive Session. INTERPHEX, October 2021.
Weinstein, Aaron. “Innovations in Supply Chain and CGT Operations.” Concurrent Session Leader. ISPE Annual Meeting, November 2021.
Weinstein, Aaron, et al. “Designing Practical and Flexible CDMO Manufacturing Suites and Integrated Facilities to Accommodate the Evolving Landscape of Cell Therapy processes.” CAR-TCR Summit Workshop, 30 August 2021, Virtual.
Weinstein, Aaron. "Qualifications and Validations Considerations for Cell and Gene Therapy Projects." SAPA-GP 17th Annual Conference, 31 May 2019, King of Prussia, PA.
Weinstein, Aaron. "CAR-T Facility Design, Startup, and CQV." IPXLive Session, 2 April 2019, New York City, NY.
Weinstein, Aaron. "Planning, Execution and Challenges." ISPE Annual Meeting & Expo, 19 November 2019, Las Vegas, NV.
Weinstein, Aaron. "Commissioning, Qualification & Validation Considerations for CAR-T Products." Sartorius Stedim Biotech - EJCLI/ASQ Technical Seminar, 6 November 2019, Bohemia, NY.
Weinstein, Aaron. “CAR-T Supply Chain: Challenging, Achievable, Realistic & Transformational.” ISPE Annual Meeting & Expo, 7 November 2018, Philadelphia, PA.
Weinstein, Aaron. “Realizing Benefits and Efficiencies from Quality Systems.” INTERPHEX, 21 March 2017, New York, NY.
Weinstein, Aaron. “Initial Planning and Overall Execution of Commissioning and Qualification on Pharma Projects.” HUG (Honeywell Users Group), 15 June 2017, Phoenix, AZ.
Weinstein, Aaron. “Environmental Monitoring in the Pharmaceutical Industry - Systems, Requirements & Considerations / Planning and Executing an Efficient Validation Effort for Pharmaceutical Capital Projects.” HUG (Honeywell Users Group), 12 June 2017, Phoenix, AZ.
Weinstein, Aaron. “The Future of Quality in Pharmaceuticals and Medical Devices: A Look Forward.” INTERPHEX, 23 March 2017, New York, NY.
Weinstein, Aaron. “Track & Trace/Serialization #1 & #2.” ISPE Annual Meeting & Expo, September 2016, Atlanta, GA.
Weinstein, Aaron. “Computer System Validation for the Rest of Us.” INTERPHEX, April 2015, New York, NY.
Weinstein, Aaron, et al. “Bringing Life Sciences to the Cloud.” June 2014.
Weinstein, Aaron. “Don't Gamble Your Project Away: Real World Lessons of Project Management Top Ten Lessons Learned: A Study in Project Management (A Strategy for Remediation Under Consent Decree: Management, Project Controls and Deliverables Related To These Challenging Projects).” ISPE Annual Meeting & Expo, October 2014, Las Vegas, NV.
Weinstein, Aaron. “Calculating Odds of Success: A Workshop on Project Management (Making a Remediation Project Work: Knowing How to Beat the Odds).” ISPE Annual Meeting & Expo, 13 October 2014, Las Vegas, NV.