Pharmaceutical and Biotech Consultants

About Us
Carbone and Associates provides Documentation and Training Solutions to the Pharmaceutical and Biotechnology Industries.

We specialize in creating detailed SOPs, and effective Training Programs. We have over 24 years experience in R&D, production, and consulting on numerous new facility startups. Through this experience, we have gained extensive knowledge of Solid and Liquid Dose manufacturing processes, equipment operations, maintenance programs, and training programs.

Below are some of the deliverables that we have provided to clients. More details can be found by using the menu bar.
Technical Writing:
Carbone and Associates has provided clients with the following:
  • Manufacturing equipment set-up, operate and clean SOPs
  • Manufacturing equipment PMs
  • Facilities equipment operating SOPs and PMs
  • Materials Management operating SOPs and PMs
  • General SOPs, including Sanitation, Room Cleaning, Pest Control, Environmental Monitoring, Gowning/Degowning
  • Quality SOPs, including Raw Material Specs, Receipt and Control of Raw Materials, Sampling and Release of Materials, Document Change Control
Training Programs:
Carbone and Associates has provided clients with the following:
  • Performance based training programs
  • OJT programs
  • Manufacturing equipment JSMs
  • Packaging lines JSMs
  • Materials Management JSMs
  • Facilities training material
  • Building and area familiarization training program
  • Lesson plans
  • New employee training material
  • Corporate C&Q training program
  • Delivered training to Manufacturing and Facilities personnel
  • Designed, developed and delivered BAS Simulation training
  • Designed, developed and programmed HMI Process Simulations
Documentation:
Carbone and Associates has provided clients with the following:
  • Process Flows
  • Personnel Flows
  • Material and Waste Flows
  • Animal Flows
  • Building and Area Familiarization material
  • Overview of HVAC and areas served
  • BAS Overviews
  • Operational Troubleshooting questions
  • Room Detail
  • Utilities Detail