Course details
This programme is designed to provide 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. The course aims to explore in some depth validation activities, the regulatory reasons of these activities and how best to meet these requirements.
Course Topics:
- Process Control – how we control processes – Line clearance, first piece, line checks and final order inspection – does this control every part we make?
- Why is validation necessary to guarantee reproducibility?
- Principles of validation.
- Drafting User Requirements Specifications (URS) and Functionality Specifications(FS).
- Review of regulatory requirements: ISO EN 13485:2012, FDA QSR’s, Guidance Documents
- The Validation Flowchart – process map
- The use of Tools for product and process validation: FMEA, DOE, etc.
- Master Validation Plan (MVP)
- Installation Qualification
- Operational Qualification, Worst Case Scenario, Operational Windows
- Equipment IQ/OQ- using URS and FS
- Performance Qualification- Design Space generation – rationale for selecting certain inputs
- Design Validation
- Clinical Testing and Validation
- Design of Experiments – how to execute one
- Process Qualification / Validation
- Grouping Rationales for Validation
- Responsibilities within the validation project team.
- Validation Documentation Stages and documents: SOP, MVP, IQ, OQ, PQ ; Protocols and Reports
- Some Compliance Issues relating to Validation
- Life Cycle approach to validation projects
- Computerized System Validation, Automation *
- Retrospective Validation
- Cleaning Validation*
- Risk Assessment & Validation
- Q & A Session
- PDCA ( Plan Do Check and Act) and Validation
- Life Cycle approach to Validation
- Preparing for regulatory compliance
* A separate course is available in Computer Software Validation. All of these topics will be expanded on and Case Studies / Examples will be included in order to best communicate the method for validation.
Updated on 08 November, 2015Course Location
About First Polymer Training Skillnet
First Polymer Training (FPT) Skillnet operates as a training network for the Plastics Industry in Ireland and is funded under the government’s Skillnets initiative. The aim of FPT Skillnet is to deliver training that is focused on the specific needs of the plastics industry and includes certification and development.
Initiated by Plastics Ireland, FPT Skillnet’s objective is to provide technical training to polymer processors, both at our centre in Athlone and in-company as required. Our administrative and course centre is now located at 7 Centre Court, Blyry Business and Commercial Park, Athlone.
A full range of plastics processing equipment is available including Fanuc (100 tonne Electric), Krauss Maffei (100 tonne Hydraulic) and Demag (25 tonne Hydraulic) moulding machines. They are delighted to announce Arburg UK have replaced the ARBURG ALLROUNDER 320C 500 170 50 tonne machine with a new ARBURG ALLROUNDER 420C 1000 290 100 tonne golden Edition machine. This machine is equipped with the latest SELOGICA Direct touch screen control.
Having a full range of plastics processing equipment on site allows FPT to deliver intensive hands on training.
How can They meet your company’s needs?
First Polymer Training Skillnet organises a calendar of courses which are delivered at our centre in Athlone. These courses are advertised regularly. HoTheyver, if your company has specific needs They can design a course to meet those needs or modify an existing course to deliver in-company.
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