Please check the entry requirements here before booking

This 5 day programme is designed to provide a detailed understanding of the process of validation for regulated industries, with particular focus on validation for the manufacture of medical devices and the requirements of ISO EN 13485 and FDA QSR. The course aims to explore in some depth:

• All validation activities;
• The reasons for these activities and how best to meet these requirements and methodologies.

All of these topics will be expanded on and case studies/examples will be included in order to best communicate the method for validation.

Introduction

A two-day course which covers the specification and selection of the equipment necessary for the entire moulding process. Starting from the machine and working outwards to cover all the key aspects of the process.

On successful completion, trainees will know the key points to be able to specify a range of capital equipment and to identify and troubleshoot a range of issues caused by incorrect specification of equipment. They should be able to consider aspects critical not only to part quality but also to productivity, capital cost and environmental impact.

Please check the entry requirements here before booking 

Operation Clean Sweep® (OCS) is an EU approved international programme aimed at improving awareness, promoting best practices and providing guidance and tools to support companies from the plastic and polymers value chain in the implementation of the necessary pellet loss prevention measures.

The initiative’s aim is to ensure that the plastic pellets, flakes and powders that pass through manufacturing facilities in Ireland are handled with the care they deserve and do not end up in our rivers or seas.

By signing up to OCS, companies make a commitment to adhere to best practice and implement systems to prevent plastic pellet loss — and that they will play their part in protecting the aquatic environment.

Led by Polymer Technology Ireland, this webinar will give participants an overview of the requirements of OCS and a practical guide to implementing the necessary steps to become a signatory of the initiative.

For more on OCS, visit https://www.opcleansweep.eu/. 

Please check the entry requirements here before booking

Programme Overview:

The ISO 13485 standard “Quality Management Systems. Requirements for regulatory purposes” is used globally by medical device manufacturers as a regulatory pathway to bring their medical devices onto some of largest worlds markets – Europe, Australia, Japan, Canada, South Korea and Brazil, etc.
This standard provides the quality system architecture to demonstrate their compliance to strict regulatory requirements in these regions

Some of the key changes to ISO 13485:2016 include:

- Inclusion of risk management across all process activities

- Additional requirements for design activities

- Additional requirements for process validation and verification activities

- Improvement in supplier control processes using a risk-based approach

- Increased emphasis on feedback methodologies

- Explicit requirements for quality system software

- For outsourced processes control based on risk and ability to meet specifications and requirements

- Detailed requirements in Technical file

- Management Review frequency determination

This course Please check the entry requirements here before booking 

This course is designed for Senior Management, Product Design Managers, Process Engineers, Manufacturing Cell Business Owners, Production Team Leaders QA and Regulatory personnel working on projects in industry.

Learners will have a complete understanding of:

• The Project Lifecycle

• Project Documentation

• Project Management Standards

Learners will be introduced to:

• Project Management Tools

• Microsoft Project

Please check the entry requirements here before booking

Programme overview

This 2 day programme is designed to provide detailed understanding of cleaning validation for regulated industries, with particular focus on medical device and pharmaceutical cleaning activities.

Please check the entry requirements here before booking

Programme Overview: 

Computer system validation is a critical tool to assure quality of computer system performance. CSV enhances the reliability of system, resulting in fewer errors and less risk to process the date integrity. A primary goal of software validation is to demonstrate that all completed software products comply with all documented software and system requirements. Confirmation is an important part of the overall design validation to ensure that all aspects of the medical device confirm to user needs and intended uses. 

Please check the entry requirements here before booking

Programme Overview: 

This course will run over 4 webinars (4 mornings) from 09:30 - 1.00pm

This course is designed to provide a detailed understanding of equipment validation for regulated industries. If you purchase or develop a new piece of equipment that is used to manufacture medical devices, in-vitro medical devices, or pharmaceutical products EU and FDA regulations require that firms have a quality system programme in place for the following.

• Calibration and maintenance of equipment
• When equipment is installed it must be done correctly against best industry practice to ensure it operates as intended against URS ( User Requirement Specification), FDS ( Functional Design Specification), and to ensure proper SAT (Site Acceptance Testing) and FAT (Factory Acceptance Testing) is completed.
• This equipment must pass through the ab ove toll gates to be considered ready for PQ (Performance Qualification) testing and generation of a design space for that process. This design space must consider the key inputs to the process which can be developed by carrying out the design of experiments using Orthogonal arrays.
• You then must guarantee reproducibility of the process by carrying out validation studies with this equipment.

We can deliver a shorter tailored programme at our centre in Athlone for you/ or on-site if you have injection moulding capability there.