Training for RA/QA Professionals of the Medical Device Industry:
Medical device sterilization for single-use medical devices plays an integral role within a manufacturer’s technical file review under the European Medical Device Directives. Sterilization is a critical process often performed by Sterilization Service Providers (contract sterilizers) but requires that the Legal Manufacturer fully comprehends its effects on the medical device’s conformity. Many Medical Device Manufacturers struggle with putting together their Technical Documentation due to a lack in understanding of the Sterilization methods, Sterilization Application, Sterilization Process Validation, and Sterilization Procedures implied.
GMED North America has created a comprehensive 3-day training course to address Ethylene Oxide (EO) and Irradiation (Gamma/E-beam) Methods of Sterilization for Single-Use Medical Devices and help manufacturers:
- Understand industrial sterilization applications of 100% Ethylene Oxide (EO) and, common Irradiation methods, including Gamma and E-beams;
- Address the requirements of EN 556-1, ISO 11737, ISO 11135, and ISO 11137
Over the course of the 3 days, the attendee will acquire a robust foundation and knowledge in:
- Defining the SAL (Sterility Assurance Level) for a medical device;
- Understanding the microbiological aspects of Bioburden, Biological Indicator (BI) and Sterility Assurance;
- The fundamentals to be laid down in order to support technical file review of Sterilization Process Validation documentation;
- The development, validation and routine control of a Sterilization process for medical devices;
Trainings provided on Ethylene Oxide (EO) and Irradiation (Gamma/E-beam) methods of terminal sterilization for single- use medical devices are scarce. Make sure you sign up today and take advantage of this limited opportunity. Acquire now the indispensable knowledge in sterilization requirements for medical devices technical file implementation and review.
Keywords: Sterilization, Irradiation, Ethylene Oxide, D- Value, Product Sterility, BI Sterility,Terminal Sterilization, Microbiology, Sterility Assurance, EO sterilization cycles, Radiation Sterilization, Harmonized Standards, Industrial Sterilization, Gamma, E-beam, Sterility, Microorganism, Bioburden, EO Sterilization, Biological Indicators, SAL or Sterility Assurance Level, Medical device.
WHO SHOULD ATTEND
- Medical device manufacturers;
- Regulatory Affairs Managers, Quality Managers, Technical and Plant Managers;
- Engineers, Laboratory staff and R & D specialists;
- Production staff wishing to deepen their theoretical and practical knowledge of sterilization;
- Basic knowledge of the sterilization standards for EO and Irradiation, i.e. ISO 11135 and ISO 11137, respectively.
- Good knowledge and effective practice of the European Medical Device Directives (93/42/ EEC or /and 90/385 / EEC)
The maximum number of participants per training session is set to 18 to guarantee a stimulating and practical working environment.
- Presentations in PDF;
- Practical working sessions;
- Course evaluation;
- Lunch meeting with the Trainer
Note: GMED North America retains the right to cancel the training 7 days before the date if the number of attendees is insufficient.
|Training content and objectives|
|DAY 1, 2, and 3: Terminal Sterilization|
|8:30 am to 9:00 am||Breakfast|
|9:00 am – 12:15 pm||
|12:15 pm - 1:00 pm||Lunch|
|1:00 pm- 5:00 pm||
Program + Exercises + Discussions
|About the trainer|