Sterilization by irradiation course
Validation of Sterilisation by Irradiation Course
Based on EN ISO 11137-1 & -2
This professional training is conducted over a one-day period, during which participants are provided with a clear and practical understanding of EN ISO 11137-1 & -2, the essential standards for the sterilisation of medical devices using irradiation. The training enables teams within companies to ensure compliance with the MDR and MDD, providing an understanding of the important aspects of validation, then controls through to the documentation of sterilisation from cradle to grave.
Through case-based learning and real-life examples, this training ensures strong technical competence in the application of EN ISO 11137-1 to -3, with an understanding of the principles of sterilisation validation, controls in routine as well as the requirements from competent authorities and notified bodies.
- Make the connection between the MDR/UK MDR 2002 and EN ISO 11137-1, -2 and -3
- Understand the requirements for validation of irradiation sterilisation
- Recognise the types of dosimeters and their compliance with ISO ASTM 52628
- Establish the routine sterilisation and batch release
- Identify and prepare the key sections of a sterilisation validation report
Learning Objectives / Course Outcomes
At the end of the training participants will be able to:
Intended Audience
This training is designed for staff who are responsible for the quality, compliance and documentation of sterilisation, which may include:
Regulatory and Quality Assurance Managers
Design and Development Staff
Quality Control Staff
Course Content
- I. Introduction
- II. Characterization of Device Materials and Analysis of Dose Response to Irradiation
- III. selection of dosimeters to use
- IV. Validation - Installation Qualification (IQ)
- V. Validation - Operational Qualification (OQ)
- VI. Validation - Performance Qualification (PQ)
- VII. Re-qualification and Maintenance Procedures
- VIII. Routine Process Control
- IX. Device Modification/Requalification and Range of Use indicators
- X. Bioburden and Sterility Validation
Prerequisites
The student should have a general understanding of:
- Principles of Microbiology
- Medical Device Packaging and Sterilization requirements
Learning Approach
Our training is engaging and involves interactive discussion, practical examples, and case based exercises to encourage participants and build their confidence as they advance through the course.
Trained by professionals with industry experience, each lesson provides participants with theoretical knowledge and a practical ability to implement successfully. Training opportunities are available online or on-site for organizations to choose the training delivery option that best fits their operational requirements.
Pricing
Online Training: £450 per participant
(Student discounts available - please reach out for more information.)
- (Student discounts available - please reach out for more information.)
- Please contact admin@mdsspro.com for pricing and availability.
Why Choose MDSSPRO
Expert-Led Training on MDR Compliant Training, Made for You
MDSSPRO combines decades of experience working in the industry with a desire to be the best at medical device compliance. MDSSPRO was founded in 2016 by Patricia Vest, and consists of experienced auditors, consultants, and technical assessors that have worked with world-leading notified bodies like TÜV SÜD, SGS, UL, and Intertek.
Our training is more than a course – it is a strategic educational partnership. We ensure that our training focuses on practical and current regulatory knowledge so that your team is confident and efficient in meeting compliance. Regardless of whether the training is delivered online or in person, every training course is developed specifically to take account of your operating and regulatory environment.
Together, let's build compliance confidence.
Utilize MDSSPRO to help with your medical device compliance and assurance that meets the highest standards of regulatory and quality. Our team will be there to assist you throughout your compliance journey, with training programmes developed around your organizational needs to expert auditing and consultancy.
