Pharmaceutical and Biotech Consultants

Training Programs
Carbone and Associates has generated effective Training Programs for manufacturing and facilities systems.
We will generate site-specific Training Programs, custom-tailored to your equipment and facility. We will deliver the training to different levels of staff. We can train your personnel to use the material, so you can continue the Training Program using in-house personnel.
Our standardized Training Material consists of Job Support Aids and Lesson Plans.
It will assist manufacturing and facilities operators in understanding the operation and troubleshooting of their equipment. Together with effective SOPs that we can generate, the operators have all the tools to operate efficiently.
Job Support Aids
We create the following Job Support Manuals (JSMs) for equipment.

Components are detailed as below:
  • Function
  • Mechanical and Electrical
  • Controls and Indications
  • Troubleshooting
Through the mechanical and electrical sections, the operator gains understanding of components that they use to set-up or disassemble/clean their equipment. Terminology is synchronized to the SOP.

Controls and indications sections provide the operator with information that they use to operate the equipment, including all screen shots for recipe selections, settings, etc.

Troubleshooting sections provide common vendor and operational occurrences, and solutions to the problems.

We translate ladder logic and complex sequence of operations into standardized, easy to read/use JSMs.
Delivery
We excel at delivering Area and Building Familiarization courses. We can provide general introductions to GMP Manufacturing environments, and have the experience to answer specific questions that employees always ask.

We can deliver Facilities training. We have an excellent understanding of facilities systems, and their interconnections. We understand building automation systems, and it's control/monitoring of GMP areas. We have the necessary background to teach facilities staff about impact to GMP environments.

We can deliver Equipment operation training. Packaging lines is our specialty. Since we generate the Job Support Manuals, we have an excellent understanding of the equipment. Together with equipment set-up, operate and clean SOPs that we can write, and our understanding of GMP working environments, it provides us with an excellent base to deliver the training.

However, we really want to develop your internal staff to provide the training. It makes sense for you to continue to provide the technical training.
Lesson Plans
We create lesson plans for trainers.
They are detailed scripts that allow a knowledgeable trainer to provide consistent OJT to operators.

The lesson plan outlines the following:
  • Purpose
  • Prerequisite Training
  • Tasks
  • Safety issues
  • GMP Compliance Issues
  • Associated Documents (JSM, SOPs)
  • Prime
  • Prompt
  • Perform
  • Practice
  • Summary
  • Evaluation

Complete Training Package
If we tie all the components together, you get the following Complete Training Package:
  • Building and Area Familiarization (introduction to whole buildings)
  • Specific Process Overviews (Manufacturing and Facilities)
  • Job Support Manuals (Equipment Specific)
  • SOPs
  • Lesson Plans (deliver consistent training)
  • Delivery (we can provide, or teach you the system)