Hoping to secure a position in the Pharmaceutical, Biotech or Medical Device industry? Your chances of success will be enhanced by having some certification in Good Manufacturing Practise (GMP). Our course is designed for one-to-one sessions or small groups and includes a review of your CV
Good Manufacturing Practice (GMP) for Managers & Supervisors
During this 1 day course we ask Leaders to examine the emphasis that they place on GMP compliance, the standards that are set and/or demanded and the clarity with which GMP is communicated to the other employees. The Course is particularly slanted to the regulatory environment in Ireland and can be focused on API, Drugs, Biologics or Medical Devices.
This course revises the GMP basics with operations personnel, while continually asking ‘can you make a difference?’ - thereby exploring the impact of non-compliance and establishing relevance to individuals job function. Particular emphasis is placed on following procedures; keeping good records; and being observant. The content can be focused on API, Drugs, Biologics or Medical Devices
Since the publication of ICH Q9, root cause analysis tools should be used as part of complaint, deviation and failure investigations. This half-day course is designed to overview aome of the techniques that can be used, e.g. fish bone diagrams, the 5 whys, process mapping and more....
This course is aimed at analysts in the QC laboaratory. Compliance in the laboratory is a critical, but varied area. THe topics that can be covered are so numerous, that you are free to choose! 'Hot topics' such as Root Cause Analysis Tools for OOS investigations are included.
Counterfeit materials is currently one of the 'HOT TOPICS' in the business. This course is aimed at revising the GMP basics with materials management, warehouse or logistics personnel - exploring all areas from purchasing to shipping. The course can be delivered as a unit or divided out into relevant modules for each department.