Life Sciences courses in Ireland

Corrective and Preventive Action (CAPA) continues to be one of the top two causes of 483s from the FDA. One of the main causes of companies receiving a CAPA 483 from the FDA is failure by the company to fully understand the FDA’s expectations of a well run CAPA system. This course provides delegates with…

Corrective and Preventive Action (CAPA) continues to be one of the top two causes of 483s from the FDA. One of the main causes of companies receiving a CAPA 483 from the FDA is failure by the company to fully understand the FDA’s expectations of a well run CAPA system. This course provides delegates with…

… motivated to study a postgraduate programme in Ireland but do not have the English language competency or familiarity with the Irish education system.

Many companies do not have their own dedicated microbiologist on site and in this case, various departments acquire responsibility for looking after the establishment and maintenance of the environmental monitoring and product testing. Personnel often are unsure of the exact regulatory requirements with regard to the testing required, how best to perform the testing so…

‘Good Laboratory Practices is a quality system concerned with the organisational process and the conditions under which non clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.’ -OECD Principles of GLP (1997) Participants achieve the following learning outcomes from the programme; Understand the requirements of a laboratory management system and…

While the Safety, Health and Welfare at Work Act 2005 and the Safety, Health and Welfare (General Applications) Regulations 2007 (as amended) impose a duty of care on employers to ensure the safety of all their employees, laboratories are often overlooked when formal hazard identification and risk assessments are carried out. Laboratories are seen to…

Validation of equipment and methods is a vital element in assuring the integrity of results from laboratories in the pharmaceutical, healthcare and medical device industries. This course covers the life cycle for laboratory equipment validation, from requirements specification to installation, operation and performance testing. It addresses the requirements for the control of electronic records and…

The Medical Device Single Audit Programme (MDSAP) is the single biggest step towards global harmonisation of medical device regulation seen to date.  This course details the main requirements of the regulations from Brazil, Australia, Canada and Japan and shows how these relate to ISO 13485: 2016 and the US QSR and how to audit against…

The Medical Device Single Audit Programme (MDSAP) is the single biggest step towards global harmonisation of medical device regulation seen to date.  This course details the main requirements of the regulations from Brazil, Australia, Canada and Japan and shows how these relate to ISO 13485: 2016 and the US QSR and how to audit against…

Manufacturers of medical devices who intend to market their products in the USA are required to comply with the regulations set out in US FDA 21 CFR Part 820: Quality System Regulation. Failure to comply with any applicable provision of the QSR renders a device adulterated under section 501(h) of the Food, Drug and Cosmetic…

Process Validation is a key requirement of Medical Device, Pharmaceutical and API regulations. A comprehensive, well thought-out approach to validation is a critical element of any company’s approach to meeting European, US and Worldwide regulatory requirements. This course gives attendees a good grounding in the practices and principles of process validation and expectations of regulatory…

Process Validation is a key requirement of Medical Device, Pharmaceutical and API regulations. A comprehensive, well thought-out approach to validation is a critical element of any company’s approach to meeting European, US and Worldwide regulatory requirements. This course gives attendees a good grounding in the practices and principles of process validation and expectations of regulatory…

ISO 14971 was updated in 2007, updated in 2009 and now updated again in 2012. Why all these changes and what are the implications for you the manufacturer? How far does applying ISO 14971 go in ensuring compliance with the medical devices directives? What does ISO 14971 contain and where, how and when should I…

ISO 14971 was updated in 2007, updated in 2009 and now updated again in 2012. Why all these changes and what are the implications for you the manufacturer? How far does applying ISO 14971 go in ensuring compliance with the medical devices directives? What does ISO 14971 contain and where, how and when should I…

The main objectives of this course are to give attendees a grounding in the principles of Software Validation, Computer Systems Validation and the latest requirements for Electronic Records and Electronic Signatures. The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the…

The main objectives of this course are to give attendees a grounding in the principles of Software Validation, Computer Systems Validation and the latest requirements for Electronic Records and Electronic Signatures. The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the…

The Medical Device Industry is currently transitioning from the Medical Device Directive (MDD) 93/42/EEC to the Medical Device Regulation (MDR) 2017/745. As an industry we need to progress through this transition period in order to keep our products on the European Market and retain our CE mark. It is important therefore that we understand the…