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…

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

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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ISO 13485:2016 – Transition Training – Recorded Live Webinar Register Now! Download the Brochure This recorded live webinar course will provide guidance on how to perform the transition to the Medical Device Quality Management System (QMS) Standard ISO 13485:2016. In Particular will discuss the following points: 1. Comparison with previous version of ISO 13485 2. Impact on existing QMS 3. Consistency with new ISO 9001:2015 4. Regulatory impact The new ISO 13485:2016 standard…

MEDICAL DEVICES AND APPLICABLE REGULATIONS (Buy Ticket Now) Download the Course Brochure Availability: Right Now (Recorded Presentation) Duration: 70 min. (the average time to complete the training program). Description: This webinar course will take you into the Medical Device Regulation field providing guideline, giving example and references to the applicable laws and standard. An overview of discussed topic is here reported: What is a Medical Devices Definition and classification Main worldwide Regulations Notified…

DESIGN CONTROL 21 CFR 820.30 – INTERACTIVE PRESENTATION TRAINING (Buy Ticket Now) Download the Course Brochure Availability: Right Now (Interactive Presentation) Duration: 70 min. (the average time to complete the training program). Description: This webinar course will introduce you to the activities that are required by FDA Design Control according to 21 CFR 820.30. Design Controls – Why? Design Controls – Regulatory History Design Controls – What are they? Design Controls – Scope The Elements of…

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