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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 
Analytical and Product Target Profiles in QbD
Assuring Quality of Supplies to Pharmaceutical and Related Industries 
Auditing for GMP Compliance 
Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program
Best Practices in Being “On-Call” for FDA Submission Audits
Best Practices in SAS Statistical Programming for Regulatory Submission 
CAPA - The Heart of Your Quality System 
CAPA: A Critical Quality System Requirement
Clean Room Technology 
Clean Room Technology Basics in a Nutshell
Cleanroom Microbiology for Non-Microbiologists
Clinical Data Interchange Standards Consortium (CDISC) 101: Part 2
Clinical Studies for Medical Devices 
Combination Product Development: Safety/Registration/Approval 
Combination Products: How to Approach the Manufacturing and Distribution Regulations
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) 
Current Industry Trends and Rethinking on QbD
Design Control and Product Validation 
Developing and Maintaining an Effective Complaint System 
Developing and Managing Supplier Quality Agreements: An Introduction
Early Stage Clinical Studies for Drugs and Devices 
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 
Ensuring Data Integrity: A Multi-Disciplinary Approach 
Ensuring Your Supply Chain through Supplier Qualification
Equipment Qualification 1.0
Establishing a Risk-Based Compliant Calibration Program 
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
Four Key Elements for Effective cGMP Compliance
Fundamentals of Nanotechnology 
Global Counterfeiting: Alarming Facts and Defensive Business Strategies 
GMP/QSR/QSIT for Medical Devices 
Good Distribution Practices 
Human Error Reduction
Implementing and Managing the Medical Device Complaint System
Implementing GEP (Good Engineering Practices) in the Pharmaceutical, Bio-Pharmaceutical, and Medical Device Industries
International Patent Law 
Investigation of Microbial Contamination in Sterile and Non-Sterile Products
Laboratory Control Basics
Laboratory Controls: Anticipate the FDA Inspection
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
Microbiological Rapid Detection Methods
Microbiology for the Non-Microbiologist
Operation of the Clean Room
Out-of-Specification (OOS) Result Investigation
Outsourcing Pharmaceutical Operations 
Packaging of Pharmaceuticals 
Patent Law 
Pharmaceutical Gas Systems Requirements
Pharmaceutical Supervisory Management Skills 
Pharmacovigilance 
Preparing for the Device Industry's 513 Exemption Changes 
Preparing for the International Harmonization of Medical Devices 
Principles of Process Validation 
Process Scale Up
Process Validation for Packaging of Pharmaceuticals and Medical Devices 
Process Validation for the Pharmaceutical and Medical Device Industries 
Purchasing Controls for the Medical Device Industry
QbD Beyond Concepts: A Practical Implementation Plan
Qualification/Validation for Bacterial Endotoxin Testing (BET)
Risk Based Clinical Trials: An FDA Insider's Guide
Risk Management in a Nutshell 
Risk Management Today: Complying with the ISO 14971: 2007 Standard 
Risk-Based Training: An Introduction
Risk-Based Training: System Design and Implementation 
Root Cause Investigation for CAPA
Safety Assessment for Medical Devices and Combination Products  
Selecting Suppliers in FDA Regulated Industries
Setting up and Implementing Vendor and Supplier Audits
Standard Operating Procedure (SOP) and Standard Test Method (STM) Requirements
Sterilization Technologies and Process Validation 
Strategies for 21 CFR Part 11 Cost Effective Compliance Using a Risk-based Approach
Strategies in Human Error Reduction 
Successful Tablet Manufacturing
Supplier Audits 
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites 
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 
Using the Lab Information Management System (LIMS) in a Stability Testing Program
Vendor and Contract Supplier Qualification 
What Engineering Thermoplastic is Right for Your Application? 
Wound Repair and Tissue Healing Through Inflammation
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