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…

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…

Every industry in Ireland today that has a cleanroom, needs to be absolutely sure that the personnel who work there, are fully aware and strictly adhere to the tight controls necessary to ensure contamination within this environment is very tightly controlled. Cleanroom personnel, when working in cleanrooms for long periods of time, can often become…

Developing an effective cleaning program for our cleanroom is critical in achieving overall product quality no matter what the cleanroom industry from pharmaceutical to medical device, electronics to healthcare. This entails establishing a cleaning procedure, choosing the correct disinfectants and validating the chosen chemicals. It also entails deciding on cleaning frequencies, schedules and responsibility, establishing…

‘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…

ISO EN 13485:2012 & ISO EN 13485:2016 is the global harmonized Quality Management Systems Standard used by medical device manufacturers to meet certain requirements to support the safety and effectiveness of the products they sell into Europe. ISO EN 13485:2016 was published on 26th February 2016 and companies have a three year transition period in which…

This two-day course will provide delegates who have completed previous Auditor training courses in Quality Management Systems with the skills, knowledge and expertise needed to understand and audit against, the new standard framework Annex SL in ISO 9001:2015. Participants achieve the following learning outcomes from the programme; Describe in outline, the framework for a generic management…

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…

This two day course serves as an introduction to Lean Laboratory. The workshop presents the concepts, tools, and techniques involved in the practical application of Lean from a pathology laboratory perspective. This course has been specifically designed to give medical scientists the practical knowledge necessary to implement lean thinking into their laboratories. To achieve this,…

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…

At present many hospital laboratories have implemented a quality management system in compliance with ISO 15189. This one day course examines the requirements of ISO 15189, its relevance in the day to day operation of a lab, interpretation of the requirements and the process based approach to auditing for compliance. Participants achieve the following learning…

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…