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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
21 CFR Part 11: Strategies for Cost Effective Compliance Using a Risk-based Approach
Analytical Methods Validation for FDA Compliance
Applied cGMPs for Pharmaceutical and Allied Industries
Assuring Your Supply Chain through Supplier Qualification
Biocompatibility Evaluation for Registration of Medical Devices and Biomaterials 
Biostatistics for the Non-Statistician - Beyond the Basics 
Bringing Nanotechnology to Your Market
Calibration in the FDA Regulated Industry
CAPA - The Heart of Your Quality System
cGMP Auditing - Strategies for Compliance 
cGMP for Pharmaceutical Production Supervisors
cGMP for Purchasing 
cGTP in a Nutshell
Clean Room Technology
Clinical Studies for Medical Devices 
Combination Product Development: Safety/Registration/Approval 
Commissioning, Qualification and Validation
Complaint Handling and MDR Reporting
Complaint Systems - The Essential Requirements
Concepts of Medical Device Packaging 
Conducting Compliant Endotoxin Testing
Conducting Effective Quality Audits
Control of Microbial Contamination in Manufacture of Sterile and Non-Sterile Products
Cost Effective Quality-by-Design and Critical-to-Quality Tools for PAT
Critical Process Cleaning and Cleaning Validation
CSOs: Are They Right for You?
Current Good Tissue Practices (cGTPs) 
Design Control and Product Validation
Documentation Management and Control
DQ: A Guide to Protecting Your Interests When Procuring Sensors
Early Stage Clinical Studies for Drugs and Devices
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals
Endotoxin Testing: Resolving Interference and Test Validation
Environmental Control and Monitoring 
Equipment Qualification in a Nutshell
Fundamentals of Nanotechnology: Science, Manufacturing and Applications 
Getting a Share of the BioDefense Grant Billions
GMP/QSR/QSIT for Medical Devices 
Good Distribution Practices 
International Patent Law for Managers, Engineers and Scientists 
Investigation of Microbial Contamination in Sterile and Non-Sterile Products
IQ, OQ, PQ
ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies
Medical Device Regulatory Compliance
Medical Devices: Strategies for Getting To and Staying on the Market 
Microbiological Control and Validation
Patent Law for Managers, Engineers and Scientists 
Pharmaceutical Water Systems 
Premarket Submissions for Software Controlled Medical Devices 
Preparing for and Surviving an FDA Inspection 
Process Validation for Packaging of Pharmaceuticals and Medical Devices 
Process Validation for the Pharmaceutical and Medical Device Industry 
Process Validation in a Nutshell 
Quality System 
Registration of Medical Devices and In Vitro Diagnostics in Europe 
Risk Analysis and Human Factors Engineering 
Risk Management in a Nutshell: An Online Training Course 
Root Cause Investigation for CAPA
Selecting a Drug Product Candidate for PAT: An Online Training Course 
Selecting and Managing CROs 
Sterilization in the Pharmaceutical Industry 
Sterilization Technologies and Process Validation 
Surviving an FDA Inspection -- FDA Inspections of Non-U.S. Sites 
System Validation, GAMP Harmonization and P.A.T 
System Validation, GAMP Harmonization and P.A.T
Technical Writing in the Pharmaceutical and Allied Industries
U.S. FDA Drug Development and Compliance 
Vendor and Contract Supplier Qualification
Writing SOPs for cGMP Compliance 
Writing When English is Your Second Language 
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