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…

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