Course Overview:

The FDA & GMPs training course, to be delivered in Limerick as an one day programme provides a grounding on the FDA and the laws it enforces. Every organisation’s management team should be at least knowledgeable of the requirements that pertain to their area of responsibility and authority.

The FDA Training Module is a must for any organisation which is supplying regulated healthcare products to the US market or to clients who in turn ship to the US.

Our FDA & GMPs training programme is also available for delivery as a Customized In-Company Course at clients facilities nationawide in Ireland, including Dublin, Cork, Limerick & Galway

Pre-requirements

This Course is designed for quality managers, REgulatory Affairs Managers, Internal Auditors of pharmaceutical manufacturing firms, cross functional team members of an implementation project.

Course Aim & Objectives:

• To provide an understanding of FDA GMP requirements of organizations supplying regulated healthcare products to the US market or to clients who in turn ship to the US
• To give you an overview of the FDA structure
• To give you an overview of the cGMP for pharmaceutical manufacturing facilities
• To give you understanding of FDA Facility Inspection
• The FDA Audit Approach & Expectations

Course Contents:

• Introduction & Class Objective
• An overview of the FDA (Food & Drug Administration)
• The FDA’s Quality System Regulation (QSR) – A History
• GMPs for pharmaceutical manufacture 
• Inspection Techniques
• Planning for an Inspection
• Conducting the Inspection
• Responding to “483s”Facility Inspection Results