GMP 1 AND QUALITY ASSURANCE

Topics covered in this module include an orientation to GMP, documentation, conducting investigations, QC (quality control) laboratory operations and management responsibilities. Upon completion, students will be able to apply these GMP practices in regulated industries.

Accordion / FAQ component

Applicants will be expected to hold a Level 5 National / Higher Certificate in Business, Science, Engineering or equivalent. Applicants with other qualifications and/or with relevant experience may also be considered through ATU Sligo’s Recognition of Prior Learning (RPL) process

Upon compeletion of this module learner will be able to:

1.Demonstrate a basic grounding in the fundamentals of GMP, its regulatory basis and the critical role these GMP practices play in ensuring that pharmaceutical products and medical devices are consistently safe and effective, and are produced to high quality standard.
 
2.Describe the roles of QA and QC within a Quality Management system and their location within the process flow. Communicate examples of QA/QC responsibilities relevant to various processes.
 
3.Describe the roles of all personnel, training, engineering, maintenance, production and contractors within a GMP organisation.
 
4.Explain and illustrate the concepts of proper documentation utilized in a GMP environment and its function in traceability investigations and formal contracts.
 
5.Participate in the use of the tools and methodologies that provide an approach for developing corrective and preventive actions that address and limit manufacturing failures.
 
6.Describe key principles that ensure the validity of all data generated within a GMP environment

Learn from world renowned academic staff in Ireland’s leading, future focused and globally recognised colleges.

Gain an accredited NFQ qualification/micro credential that you may count towards a full award if you so wish in the future.

Previous modules may be used as recognition of prior learning towards Advance Centre degree programmes.

Equip yourself with the latest in demand skillset, tools, know-how and knowledge to succeed in your career.

Gain a competitive edge, influence growth and steer strategic goals in your organisation upon completion of your studies with the Advance Centre.

Detailed Course Information

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