What you'll learn
HOW IS PRODUCT VALIDATION PERFORMED ON MEDICAL DEVICES?
REQUIREMENTS FOR PRODUCTION VALIDATION ON MEDICAL DEVICES
PRODUCTION VALIDATION(IQ),(OQ),(PQ)STUDY ON MEDICAL DEVICES
PRODUCTION VALIDATION STUDY PROTOCOL AND REPORTING ON MEDICAL DEVICES
Requirements
No experience or prerequisites required
Description
1 What is Validation2 Terms and definitions3 Related Standards, Regulations and Legislations4 Scope5 Responsibility6 Validation Planning/Validation Protocol7 Determination of IQ (Setup)Validation Process(s)8 (OQ) Operation VALIDATION9 (PQ) Performance VERIFICATION10 Detection of Inappropriate Situations/Inappropriate Data11 EVALUATION OF VALIDATION12 Process Traceability13 Re-validation14 Confirming Validation15 Validation Protocol Examples-What are the production process and verification stages, which constitute the basic requirements of 93/42 EC Medical Device Directives and 745/2017 Medical Device Regulatory Directives and EN ISO 13485:2016 Quality Management System Standards, how they are processed, how they are approved in our Production validation training course with content such as It is an academic education training in which all processes from and to the acceptability of the final product are discussed. The basic requirements in education are given with concrete examples and in an understandable way. At the same time, the quality management system,7 Product Realization ,7.1 Planning the Realization of the Product7.2.1 Identification of Product-Related Terms7.2.2 Review of Product Terms7.3 Design and Development7.5 Production and Service Provision7.5.1 Control of Production and Service Provision7.5.2 Cleaning of the Product7.5.6 Validity of Production and Service Provision Process7.5.8 Identification7.5.9 Traceability7.5.11 Product Storage-Standard items are also mentioned and explained simultaneously.
Overview
Section 1: Giriş
Lecture 1 Production Validation Start
Lecture 2 Production Validation Section 1.1
Lecture 3 Production Validation Section 1.2
Lecture 4 Production Validation Section 2
Lecture 5 Production Validation Section 3
Lecture 6 Production Validation Protokol Report Sample
For all employment Candidates and employees, Biomedical, Chemist, Medical Engineer, Biologist, Bioengineer, Production Chief, Quality Management Representatives, Quality Control Officers,


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