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Who should attend A Comprehensive View of FDA Regulations for Medical Devices: 2 - Day In-Person Seminar
Quality Managers, Quality Engineers, Quality Assurance and Quality Control, Regulatory Affairs Managers, Regulatory Affairs Professionals, R&D Managers, R&D Engineers, Product Design and Development, Operations Managers, Production Managers and Supervisors
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Seminar Summary:

The seminar will help you understand the four major parts of the US regulatory structure: laws regulations, guidance, and consensus standards. Risk class and the panels, established by law, characterize medical devices in the US. (see full course description)

 
 
 

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Training Course Syllabus:


A Comprehensive View of FDA Regulations for Medical Devices: 2 - Day In-Person Seminar  -  FDA Regulation / Compliance training seminar
By: Dan O'Leary, President at Ombu Enterprises, LLC

Course Description:

Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.

Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.”

This two day interactive course on FDA regulations for medical devices will:

Cover more than just the Quality Management System
Provide an overview of regulations and how they fit together
Explain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementation
Help attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards
Teach the current device marketing regulations
Discuss how to handle FDA inspections and effectively respond to inspectional observations and 483s

A Comprehensive View of FDA Regulations for Medical Devices Course Outline:

Day One (8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Legal and Regulatory Organization
Laws
Regulations
Guidance
Recognized Consensus Standards
FDA Organizational Structure
Medical Device Classification
Device Classes
Device Panels
Device Regulations
Product Codes
Premarket Activities, Registration, and Listing
Clearing devices, the 510(k) paradigm
Approving devices, the PMA paradigm
Establishment registration
Device listing
Management Controls
Quality Policy and Objectives
Management Review
Internal Quality Audits
Design Controls
Input
Output
Design Verification
Design Validation
Risk Management
Design Review
Design Records
Corrective and Preventive Actions
Distinguish among Correction, Corrective Action, and Preventive Action
Applying statistical methods to reveal issues
Implementation
Medical Device Reports (MDRs)
Linking Complaints and MDRs
When to report
What to report
Corrections and Removals
What they are
When to report
When to keep records, but not report
Medical Device Tracking
Determining if a device is tracked
Maintaining the database
Auditing the database

Day Two (8:30 AM - 4:00 PM)


Unique Device Identification
The regulation
Implementation issues
Production and Process Controls
Control of IM&TE
Equipment maintenance
Process validation
Software in production and the QMS
Sterilization Process Controls
Sterilization methods
Sterility Assurance Level (SAL)
Sterilization as a validated process
Material Controls
Purchasing
Handling and Storage of Material
Records, Documents, and Change Controls
Device Master Record
Device History Record
Quality System Record
The records FDA Investigators should not examine
Electronic Records
The role of Part 11
Practical issues from the guidance document
Statistical Techniques
Determining and documenting statistical techniques
Special considerations for sampling plans

Seminar Summary:

The seminar will help you understand the four major parts of the US regulatory structure: laws regulations, guidance, and consensus standards. Risk class and the panels, established by law, characterize medical devices in the US. (see full course description)

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