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MDPharmaCourses | Regulatory, Quality and Compliance Training
23
Apr

How FDA Trains Its Investigators to Review CAPA, and Best Practices for Preparation

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:…

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MDPharmaCourses | Regulatory, Quality and Compliance Training
29
Mar

Complaint Handling in Compliance with FDA and ISO Regulations – 1,5 hours webinar

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…

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MDPharmaCourses | Regulatory, Quality and Compliance Training
2
Aug

TRADITIONAL 510 K – FDA REGISTRATION – REGULATORY- WEBINAR TRAINING + 510 Template

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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4
May

NEW WEBINAR – FDA REGISTRATION MEDICAL DEVICES, IVD, COMBINATION PRODUCTS

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…

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20
Mar

New Webinar Course – DESIGN CONTROL 21 CFR 820.30 – INTERACTIVE PRESENTATION TRAINING

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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