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Medical Device Training Courses on Regulations and Validation from CfPA Medical Devices/Diagnostics
  

Medical Device Training

WHY IS MEDICAL DEVICE TRAINING IMPORTANT?
Medical device training helps you to fill the void between the curriculum of a theoretical education and the practical demands of adhering to medical device regulations and validation processes; medical device training is also needed to assure that the specifications for the device and manufacturing process are adequate to produce a device that will conform to the approved design characteristics.




As the leader in continuing education and accredited technical training, The Center for Professional Advancement (CfPA) offers the most comprehensive and up-to-date selection of medical device training courses. Online and public courses run one- to five- days in length and include discussions, case studies, and group exercises which are taught by top industry leaders who share their knowledge in an enthusiastic, interactive manner. 


Medical Device Regulations and Medical Device Validation

WHAT ARE MEDICAL DEVICE REGULATIONS?
Medical device regulations are intended to protect the user against the risk associated with the design, manufacture and packaging of medical devices.

The following highlighted medical device training courses offered by CfPA focus on medical device regulations and compliance:


WHAT IS MEDICAL DEVICE VALIDATION?
As defined by FDA's 1987 Guideline on General Principles of Process Validation, validation - such as medical device validation - is "Establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes."

Validation is a requirement of Good Manufacturing Practices (GMP).

The following highlighted medical device training courses offered by CfPA focus on medical device validation:


WHEN AND WHERE CAN I GET MEDICAL DEVICE TRAINING?

Browse the Medical Device Training Courses listed below. CfPA can also bring any Medical Device Training Course to your location. Please click here for more information about our Client-Site Programs.


Course TitleScheduled
A Risk Based Approach to Computer Systems Validation
A Survey of Microbiology for the Pharmaceutical, Biotechnology, and Medical Device Industries
An Overview of Documentation Requirements in FDA Regulated Industries
An Overview of Process Validation for the Pharmaceutical, Medical Device and Related Industries
Analytical and Product Target Profiles in QbD
Applied Project Management Fundamentals
Assuring Quality of Supplies to Pharmaceutical and Related Industries 
Auditing for GMP Compliance
Automating GMPs: The GAMP
Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program
Best Practices in Being “On-Call” for FDA Submission Audits
Bringing Nanotechnology to Your Market
Building the eCTD for FDA Submission 
CAPA - The Heart of Your Quality System 
CAPA: A Critical Quality System Requirement
CDRH: Get Ready for Changes!
cGTP in a Nutshell
Clean Room Technology 
Clean Room Technology Basics in a Nutshell (First in a Three Part Series)
Clinical Studies for Medical Devices 
Combination Product Development: Safety/Registration/Approval 
Combination Products: How to Approach the Proposed Manufacturing and Distribution Requirements
Commissioning, Qualification and Validation 
Compare and Conquer SAS Programming Techniques for FDA Submissions
Conducting Effective Quality Audits
Control of Microbial Contamination in Manufacture of Sterile and Non-Sterile Products
CSOs: Are They Right for You?
Current Good Tissue Practices (cGTPs) 
Data Integrity: The Proof’s in the Inputting
Design and Implement a Risk-Based Training (RBT) System
Design Control and Product Validation
Developing and Maintaining an Effective Complaint System
Developing and Managing Supplier Quality Agreements: An Introduction
Effective QbD (Quality by Design): A Second Generation Approach 
Effective Tools in Selecting a CRO 
Electronic Records: 21 CFR Part 11-Revisited
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals 
Enhancing and Defining Analytical Testing using QbD (Quality by Design) 
Ensuring Data Integrity: A Multi-Disciplinary Approach 
Equipment Qualification 1.0
Failure to Warn and Medical Device Preemption
Failure to Warn and Preemption 
FDA Briefing–October 2011 
FDA's 510(k) Premarket Notification Program: What It Is and Where It's Going
Fundamentals of Nanotechnology 
Global Counterfeiting: Alarming Facts and Defensive Business Strategies 
GMP/QSR/QSIT for Medical Devices 
Implementing and Managing the Medical Device Complaint System
Implementing GEP (Good Engineering Practices) in the Pharmaceutical, Bio-Pharmaceutical, and Medical Device Industries
Implementing Supplier Audits
International Patent Law 
Introduction to cGMP System-Based Audits
Investigation of Microbial Contamination in Sterile and Non-Sterile Products
Key PAT Concepts: Focus on Design of Experiment
Key PAT Concepts: Focus on Design Space
Key PAT Concepts: Focus on Desired State
Lean Methodology: Eliminate Waste, Improve Efficiency, Increase Profits
Managing FDA Inspections: the FDA investigator cometh...are you ready?
Managing Purchasing Controls for Medical Device Companies 
Medical Device Quality Systems: How to Comply with Global Regulations  
Medical Device Regulatory Compliance 
Medical Devices: Strategies for Getting to and Staying on the Market 
Microbiological Control and Validation
Microbiology Fundamentals Relating to Clean Rooms (Second in a Three Part Series)
Operation of the Clean Room (Third in a Three Part Series)
Outsourcing Pharmaceutical Operations 
Overcoming the Challenges to Transdermal Drug Delivery Development–An Introduction
Patent Law 
Pharmaceutical Supervisory Management Skills 
Polymers and Their Use in the Medical Device Industry
Preparing for the Device Industry's 513 Exemption Changes 
Preparing for the International Harmonization of Medical Devices 
Principles of Process Validation 
Process Validation for Packaging of Pharmaceuticals and Medical Devices 
Process Validation for the Pharmaceutical and Medical Device Industries 
Proven Methods to Root Cause Analysis for CAPA
Purchasing Controls for the Medical Device Industry
QbD Beyond Concepts: A Practical Implementation Plan
Risk Hazard Assessment for Validation– ISO14971, HACCP, FMEA, FAULT TREE
Risk Management Today: Complying with the ISO 14971: 2007 Standard 
Risk-Based Training: An Introduction
Root Cause Investigation for CAPA
Safety Assessment and Biocompatibility Evaluation
Setting up and Implementing Vendor and Supplier Audits
Sterilization Technologies and Process Validation 
Strategies for 21 CFR Part 11 Cost Effective Compliance Using a Risk-based Approach
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites
Tactics to an Effective FDA Submission
The Coming Medical Device Revolution
The Pharmaceutical Supply Chain: Good Distribution Practices
The QbD Toolbox: Resources That Help New QbD Programs
The Validation of Computer Systems and 21 CFR Part 11 
Updates on Process Validation for Medical Devices…New Approaches and Practice
What Engineering Thermoplastic is Right for Your Application? 
Wound Repair and Tissue Healing Through Inflammation
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