Drawing upon the comprehensive medical devices expertise within the company, RSQA both contributes to and runs training courses and seminars aimed specifically at medical devices Quality Assurance and Regulatory Affairs personnel from International Companies and Notified Bodies.
As a part of this function, RSQA seeks to maintain expertise in all emerging medical devices regulatory matters: most recently this has included construction and presentation of training courses and seminars on the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD).
Note that RSQA does not run public courses: we find that we can best address our clients' needs by running "in-house" courses at clients' premises.
RSQA’s IVDD course in common with other RSQA products, is modular and may be tailored to meet individual client’s requirements. The course aims, through lectures, seminars and group exercises to provide delegates with detail knowledge of the Directive’s provisions, and may where requested be combined with a written examination: questions are derived from the Directive itself, and from RSQA’s medical devices auditing experience. Successful examination candidates are provided with appropriate Certification.
As required, the IVDD course may be combined with other complementary modules, such as ISO 13485, GMP, Process Validation and others from RSQA’s range.
This course is intended for medical devices Quality Assurance professionals who are already familiar with ISO 9001, and ISO 13485, but require to enhance their knowledge of this important legislative document and the documents which transposed it into UK law, viz. S.I. (1994) No 3017 and its amendments - The Medical Devices Regulations.
As required, this course can be tailored to the requirements of Certification Bodies contemplating application for designation as a Notified Body under the above Regulations, and in this form includes an examination with appropriate Certification for successful candidates.
This course is intended for Quality Assurance and Production professionals who already have detail knowledge of the application of ISO 9001, and are making the transition to a medical devices environment. The course is modular, and aims to provide delegates with detail knowledge of the Standard and applicable Guidance Documents. It may be combined with other elements as required.
This course is subject to frequent revision according to the latest publications from the Global Harmonization Task Force Study Group 3.
Delegates are assured of the most up-to-date information obtainable on this most critical aspect of medical devices production. The modular format includes Definition of Key Terms, Rationale for Validation, the Construction of Effective Validation Teams, detail of IQ, OQ and PQ requirements and their planning, suggested models for Protocols for IQ, OQ and PQ, and the construction of User Requirements Specifications.
This course is intended for assessors, microbiologists and QA professionals whose work requires knowledge of the European Harmonized Sterilization Standards, and the processes to which they relate.
Each aspect: steam, ethylene oxide, and Gamma radiation is explored in depth, and exercises are provided to assist delegates in assessing their understanding of the course material.
This training course is aimed particularly at medical devices QA and Production professionals who are not microbiologists by training, but require to fully aware of the microbiological constraints and requirements placed upon their production and control systems by current and future Standards and legislation.
No previous knowledge of microbiology is assumed, and modules include History of Microbiology, Microscopy, Cultural Methods, Sterilization and Disinfection, Cleaning Processes, Cleanrooms and Controlled Areas, and Microbiological Audits.
Where possible, practical exercises in handling non-pathogenic microorganisms are included.
Please see the Example Course
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