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Course description

Key Topics Covered:

Who Should Attend?

Learning Outcomes

With the current ongoing USFDA findings in INDIAN Drugs manufacturing facilities across INDIA
it is now very much suitable to have focus on GMP and regulatory system on the shopfloor. This course shall provide better understanding on the different FDA findings vis-a-vis its remedies required on the shop floor. we shall take USFDA findings of last 2-years and categories related to manufacturing observations  shall be discussed with probable solution to overcome such issues on the manufacturing segment.
Separate API and Formulation manufacturing examples shall be set ( Other than FDA findings) and probable remedies shall be discussed.
Overall this course shall provide a strong understanding on the remedies based on examples available from different regulatory audits in the manufacturing area.
1. Manufacturing system requirements based on the recent GMP guidelines.
2. Loopholes in manufacturing area which need to be plugged in.
3. Human psychology on the shop floor and associated risks to GMP in the manufacturing area.
4. Predictive approach in plugging GMP issues on the shop floor.
5. Threats from microbes and its controls in aseptic manufacturing system.
6. Endotoxin ( BET ) control systems in aseptic manufacturing system.
7. Right Sourcing of materials for making manufacturing GMP undisturbed.

This course should be attended by shop floor Manufacturing Executives, Manufacturing Managers and Departmental heads who take the decisions on the shop floor. SCM managers who are responsible for providing raw and packaging materials to aseptic manufacturing and API manufacturing should also attend to have clarity on GMP compatible sourcing requirements.

Learning would in the following areas;
1. Better understanding on the FDA requirements vis-a-vis current status of the organization.
2. What to do what to not to do on the shop floor.
3. Foresightedness on the GMP failure areas and acting on proactive steps.
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Section 1
Final Quiz