MDPharmaCourses | Regulatory, Quality and Compliance Training

Live Webinar: Drafting of the Biocompatibility report in accordance with ISO 10993-1 – 15 SEP 17 Duration: 50 min. + 10 min. Questions Time. Register Now! Download the Course Brochure   Description: ISO 10993-1:2009 describes: the general principles governing the biological evaluation of medical devices within a risk management process; the general categorization of devices based on the nature and duration of their contact with the body; the evaluation of existing relevant…

MDPharmaCourses | Regulatory, Quality and Compliance Training

Live Webinar – Regulation 745/2017 on Medical Devices – 5 Lessons – 8 Hours Register Now! Description: Prerequisite: basic knowledge of medical devices Recipients: Quality Assurance, Regulatory, Top Management of companies that manufacture, Import, Distribute medical devices in Europe and their suppliers   Complete learning program: 09 Jun – Regulation 745/2017 on Medical Devices: main changes and timeline to implementation  16 Jun – Regulation 745/2017 on Medical Devices: obligations of the…

MDPharmaCourses | Regulatory, Quality and Compliance Training

How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation   Register Now!     Description: Areas Covered in the seminar Documents Used by FDA Inspectors Operations Manual (IOM) CAPA Implications, by Section Requirements Recommended Methods of Compliance for Each Requirement CPG Manual 7382.845 CAPA Implications, by Section Requirements Recommended Methods of Compliance for Each Requirement QSIT Manual Description/explanation of each CAPA Inspectional Objective Recommended Methods of Compliance LEVEL:…

MDPharmaCourses | Regulatory, Quality and Compliance Training

Complaint Handling in Compliance with FDA and ISO Regulations – 1,5 hours webinar Register Now! Description: Areas Covered in the seminar ·         FDA and ISO requirements for complaint handling ·         Establishment of complaint handling program ·         What constitutes a complaint ·         How to Handle “non-complaints” ·         The roles of investigation and corrective action in complaint handling ·         Complaint trending and reporting ·         Application of risk management to complaint handling program ·         Benefits/Detriments of a Reply…

Live Webinar Clinical Evaluation and literature data according to MEDDEV 2.7.1 rev June 2016 – May 29 Register Now! Description: The course is aimed at Quality Assurance personnel, Regulatory and Research and Development of biomedical companies, medical device manufacturers of any class, agents and distributors. The course describes the main methods for writing an Evaluation Report of the clinical data to be included in the dossier of the product Technical according…

MDPharmaCourses | Regulatory, Quality and Compliance Training

Live Webinar – Technical File Structure according to New Medical Device Regulation Register Now! Duration: 50 min. + 10 min. Questions Time. Description: The course is aimed at Quality Assurance personnel, Regulatory and Research and Development of biomedical companies, medical device manufacturers of any class, agents and distributors. The course describes the methods of Unique Device Identification (UDI) and traceability of products for the CE marking and its main aspects as in…

MDPharmaCourses | Regulatory, Quality and Compliance Training

Live Webinar – Technical File Structure according to New Medical Device Regulation Register Now! Duration: 50 min. + 10 min. Questions Time. Description: The course is aimed at Quality Assurance personnel, Regulatory and Research and Development of biomedical companies, medical device manufacturers of any class, agents and distributors. The course describes the structure and content of a technical file and its main attachments for the CE marking of a medical device. LEVEL: INTERMEDIATE…

MDPharmaCourses | Regulatory, Quality and Compliance Training

GD&T Geometric Dimensioning & Tolerancing Presentation Webinar Register Now! Description: GD&T is a system of symbols and features used in machining, manufacturing, quality and design that specify the shape, orientation, size, and critical features of the object of the drawing. GD&T is used to ensure that everyone is on the same page regarding how a feature or part is defined. This training will introduce to the basic concept and provide the necessary…

MDPharmaCourses | Regulatory, Quality and Compliance Training

NEW EU Medical Device Regulations 2016-Live Webinar  Register Now! Download the course Brochure  Duration: 50 min. + 10 min. Questions Time. ON DEMAND: Fill the form below to schedule the live webinar on demand session: Description: This live webinar course will provide guidance on the new requirement introduced with NEW EU Medical Device Regulation. In Particular will discuss the following points: Main New Requirements (UDI) Unique Identification number Post market activities New Technical…

MDPharmaCourses | Regulatory, Quality and Compliance Training

Medical Device Sterilization Process  LIVE WEBINAR 22 February 2017 Register Now! Download the Course Brochure Duration: 50 min. + 10 min. Questions Time. Description: The course is aimed at staff of Quality Assurance, Regulatory and Research and Development of biomedical companies manufacturing of sterile medical devices, their suppliers and subcontractors. The course includes a theoretical introduction to the concept of sterilization and a description of the main sterilization methods used currently; also…

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