GMP for Food, Biotech and Pharmaceutical Products

Objectives:

Understand Good Manufacturing Practice and be able to explain it to others within your organization. See how current GMP becomes a part of your compliance strategy. Institute changes in your organization that will move it towards GMP compliance. Audit your own manufacturing organization. Suggest corrective action in the event of non-compliance. Be able to help manufacturing management prepare for a formal inspection. Know how to validate a manufacturing process or unit operation. Challenge the proper installation and commissioning of new equipment within your facility. See Good Manufacturing Practice as part of a total quality control system. Bring more manufacturing discipline to your organization. Understand the difference between GMP and Good Laboratory Practice. Appreciate the challenges faced by regulatory agencies themselves. Have sufficient knowledge to write a Master Production Record. Cite examples of compliance in a manufacturing environment.