Medical Devices Regulation

Introduction

Features

Duration

Eligibility

This training course imparts knowledge and practical understanding about the Medical Devices types, regulatory overview and approval process.

Course Code: KPE-C-018

Course Title: KPE’s Certificate Course in Medical Device Regulations.

This online course utilizes interactive learning tools to guide each participant through the steps of medical devices regulations and approval process in details. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

The course can be completed at any pace, allowing the user to stop and start at their leisure.

Who should attend?

Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
Those moving into regulatory affairs from other areas within a medical devices company (Pharmacists, Clinical Trials, Marketing and others)
Anyone wishing to update their knowledge on Medical devices industry
Anyone who want to know / update about the Medical Devices Business Management / Strategic Planning

1. Orientation to practical understanding Medical Devices classifications and understanding of the regulatory approval process.

2. Simulation to real life Strategic planning in medical devices management – premarket and post market.

3. Access to industry case studies.

4. Attend Live Lectures of all different chapters / study content.

1 Month

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to know or upgrade their knowledge about medical devices regulation, can pursue the course.

Section 1US Medical Devices

Lecture 1Overall Understanding of US Medical Devices

Lecture 2Definition of Medical Devices

Lecture 3Classification of Medical Devices

Lecture 4Medical Devices Work File

Lecture 5Review Test

Section 2510k Pre-market Notification

Lecture 6Overall Understanding 510k - Pre-market Notification

Lecture 7Predicate Devices | Substantially Equivalent (SE) |Types of 510(k)s

Lecture 8Understanding on 510k | Types of the 510k | Timeline | Difference with PMAFDA 510(k) Step By Step - Decision Making process

Lecture 9FDA decision making process for different classes of 510k applications

Lecture 10Review Test

Section 3Premarket approval (PMA) application

Lecture 11What is Premarket approval (PMA) application?

Lecture 12Differences between 510k VS. PMA

Lecture 13Data Requirements for A Premarket Approval (PMA) application | Dossier Template | FDA action plan post submission of the PMA application

Lecture 14PMA - Quality System

Lecture 15Labeling Requirements

Lecture 16Investigational Device Exemption | Device Clinical Research | Early/Expanded Access of Medical Devices | Q-Sub | IDE Submission Requirements

Lecture 17PMA Postapproval Requirements

Lecture 18Medical Devices Development to Commercialization Stages | Devices Clinical Trial | Stages | Critical differences with pharmaceutical clinical trial

Lecture 19Medical Devices Post Approval Variations | PMA supplement | PMA amendments | Variation Management Strategic Planning

Lecture 20Expedited Review of PMA application

Lecture 21Expiration Dates

Lecture 22Device Master Files

Lecture 23Unapproved use of Medical Devices

Lecture 24Marketing, Advertising and Promotion of Medical Devices

Lecture 25Significance of Submitting a FDA 513(g)

Lecture 26DeNovo Petition - Types of DeNovo Pathways | Details of Review Process | Strategic Planning

Lecture 27Humanitarian Device Exemption (HDE)

Section 4Combination Products

Lecture 28Definition of combination products

Lecture 29Examples of Combination Products

Lecture 30Premarket Review and Postmarket Regulation of Combination Products

Section 5Medical Devices Regulation in Canada

Section 6EU Regulation for medical devices

Lecture 32Medical Devices: EU Directives, Classification and Guidance, CE Marking.

Lecture 33EU Medical Devices Regulation - New Updates

Section 7QMS for Medical Devices

Section 8c-GMP Requirement for Medical Devices

Lecture 35c-GMP Requirement for Medical Devices

Lecture 36Product Recall | Product Withdrawal | Handling and Management of Product Recall

Lecture 37Establishment Inspection Report | 483 Observations | USFDA Warning Letter | Handling of FDA inspection | Closing of Warning Letter

Lecture 38Documentation | Good Documentation Practices

Lecture 39Training on Handling and Management of Data Integrity issues in Pharmaceutical, Biopharmaceutical and Medical Devices Industry

Section 9Medical Devices Regulation in India

Section 10CE Marking

Lecture 41Introduction to CE Marking

Lecture 42CE- Self Certification

Lecture 43General principles of the CE marking

Lecture 44Manufacturer Responsibilities

Lecture 45Third Party Medical Device Manufacturing & CE Marking

Lecture 46Classifying Medical Devices Based on the Type of Manufacturing Operation

Lecture 47Understanding Terminologies - OBL/PBL/PLM/OEM/OES

Lecture 48Step By Step CE Marking Process

Lecture 49Case Study

Section 11Technical Dossier

Lecture 50Introduction to Medical Devices Technical Documentation

Lecture 51Components of technical documentations

Lecture 52Technical Dossier - Information Required

Section 12ISO 13485:2016 : Implementation in Medical Device Organization

Lecture 53Introduction to ISO 13485:2016

Lecture 54 ISO 13485:2016 Audit Checklist

Section 13Medical Devices Regulation in Asian Countries - UAE, Bangladesh, Bahrain, Indonesia, China, India, Iran, Jordan, Japan, Kuwait, Korea, Lebanon, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, Vietnam

Section 14Medical Devices Regulation in Asian Countries - UAE, Bangladesh, Bahrain, Indonesia, China, India, Iran, Jordan, Japan, Kuwait, Korea, Lebanon, Malaysia, Pakistan, Philippines, Saudi Arabia, Singapore, Vietnam

Section 15Medical Devices Regulation in African Countries: Algeria, Kenya, Nigeria, South Africa, Egypt

Section 16Final Examination

Lecture 58Registration for final examination

Lecture 59Final Examination