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

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

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

WEBINAR TRAINING – TRADITIONAL 510 K – FDA REGISTRATION – REGULATORY (Buy Ticket Now) Download the course Brochure Availability: Right Now (Recorded Presentation) Duration: 30 min. (the average time to complete the training program). Description: This webinar course will describe how to manage a new Traditional 510k, providing description of the details to include in each Section of the application. The specific points that will be treated in the webinar are: When a…

FDA REGISTRATION: MEDICAL DEVICES, IVD, COMBINATION PRODUCTS (Buy Ticket Now)  Download the Course Brochure Availability: Right Now (Interactive Presentation) Duration: 50 min. (the average time to complete the training program). Description: This Webinar course will introduce you to the FDA Regulation for Medical Device, IVD and Combinations products: Device Classification Class I Medical Device Class I device exemptions Class II Medical Device Investigational Device Exemption (IDE) Class III Medical Device PMA…

CLINICAL EVALUATION OF MEDICAL DEVICES (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 course provide a guideline on how to prepare a clinical evaluation for a Medical Device, considering the applicable laws and standard, providing example and also a guideline in setting up a SOP for the conduction of clinical evaluation. An overview of discussed topic is…

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…

Free Webinar Presentation – Injection Molding Process (Go to free content) Duration: 35 min. (the average time to complete the training program). Description: This course will introduce to the injection molding process, giving you an overview of the following: Thermoplastic and Thermosetting materials Injection molding Why and Why not Part Design Tooling Design Machine and parameters Certification Requirements:Certificate will be sent in PDF after completing the course. Online Training Programs Include: 90 days of 24/7 access to…

Webinar Presentation – Bioabsorbable Polymer material for Medical Device Applications (Buy Ticket Now) Duration: 70 min. (the average time to complete the training program). Description: This course will cover all the following topics related to the use of Bioabsorbable Polymer (PLLA, PLA, PLDLA, PGA..) for Medical Devices Applications: Benefit and Disadvantages Main types of bioabsorbable polymers Most common Applications How they are build Material Properties for a Medical Device Applications Degradation Process Processing…

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