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…

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NEW Clean Room Live Webinar: ISO 14644:2015,design and construction, compliance, personnel behaviour –  Register Now! Download the course Brochure Duration: 50 min. + 10 min. Questions Time. On Demand Fill the form below to define a suitable timeframe.    Description: Controlling contamination is essential in many manufacturing and research activities. The use of clean rooms, along with strict and stringent processes, makes this possible. ISO has a series of standards dedicated to clean…

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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…

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…

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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