Wayne Back

With over 30 years of experience in the field, I specialize in taking projects from concept to delivery for unrestricted operation, based on customer-generated critical quality attributes. I can design or provide quality reviews of facilities, including HVAC, BAS, BMS, and room construction. Additionally, I offer expertise in utilities, equipment, data acquisition control systems, and the requisite databases and reporting systems. My extensive experience includes over 20 years in CSV and DI program development. I am dedicated to ensuring the highest standards of quality and compliance for your business.

2020 to Current: Site Data Integrity Manager.

2000 to 2020: Site Computerized System Validation Expert Transitioning to Data Integrity in 2015 upon release of 2015 MHRA guidance. 

Since 1995: Writing and executing Facility and Equipment Commissioning and Qualification documentation. Equipment includes, but is not limited to:

  • Facilities
  • HVAC
  • Building Management Systems (BMS)
  • Environmental Monitoring Systems (EMS)
  • USP Purified Water Systems
  • Compressed air and nitrogen
  • Glatt Air Techniques (GAT) Fluid Beds
  • Vertical Granulators
  • Lyophilizer
  • Tablet Press
  • Capsule Filler
  • Capsule Check Weigher
  • Stick Pack
  • Bottling, Packaging
  • Mills: Granu, Bead, Hammer, etc

Reach Out

Get in touch with me for expert remote document support services for pharmaceutical and non-regulated companies. Let's work together.