Knowledge, Skill and Passion Graphic Goes Here - 385px by 95px

IPS

image

Michael Westerman

Compliance Project Manager

Compliance Expert

Areas of Expertise

  • CQV Project Management
  • Strategic CQV Program Development (ASTM, EU, FDA)
  • Packaging Process Validation / Equipment CQV
  • New Technology CQV Planning (Serialization / Single Use Systems)
  • Compliant Facility Design (Global Requirements)
  • Maintenance and Calibration Program Development
  • CQV Risk Assessment and Mitigation from the “Factory to the Floor

 

Start with the end in mind and perform with intent and integrity.

- Michael Westerman
Compliance Project Manager

Michael has over 15 years of experience providing project management, equipment, software, process validation, and quality/operational management in regulated industries.  His industry experience, backed up with a strong educational background in biology, technical quality engineering and business, uniquely positions him to be successful in a wide variety of leadership roles in the biotech/pharma industry.

Michael’s experience in the area of CQV project delivery includes project management, master planning, and project cost/schedule development/tracking, risk assessment, FAT/SAT assistance, commissioning, qualification, validation, training, system turnover/documentation and interfacing with project team members.  He has a passion for working with the IPS team to deliver the best possible solutions for our clients while providing meaningful career opportunities and challenges for our most important resource – our talented team of compliance professionals.

Michael volunteers his time to various industry and non-industry organizations.  He has a strong belief that giving back not only enhances others, it enhances yourself as well. Most recently, Michael has been working with the ISPE PV Committee to draft guidance for PV Lifecycle Implementation at Contract Manufacturer’s and PV Guidance for OSD Packaging.
 

  • p. 888.366.7660

Recent Projects

  • CQV Master Planning for Bulk Clinical Biological Manufacturing Facility using Single Use Materials
  • CQV Execution of Large Scale OSD Manufacturing Facility
  • CQV Execution Planning for a Novel GMP Spray Drying Facility
  • EPCMV CQV Program Management for Global Pharmaceutical Manufacturer
  • Global Serialization Implementation Assessment