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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
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
Assuring Quality of Supplies to Pharmaceutical and Related Industries
Biocompatibility Evaluation for Registration of Medical Devices and Biomaterials 
Bringing Nanotechnology to Your Market
CAPA - The Heart of Your Quality System
cGTP in a Nutshell
Clean Room Technology 
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 
Complaint Systems - The Essential Requirements
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 Control and Product Validation
Developing and Maintaining an Effective Complaint System
Effective Tools in Selecting a CRO 
Endotoxin Testing: Drugs, Medical Devices and Biopharmaceuticals 
Equipment Qualification in a Nutshell
Failure to Warn and Medical Device Preemption
Failure to Warn and Preemption 
FDA Quarterly Briefing: Focus on Medical Device News–December, 2009
FDA Quarterly Briefing: Focus on Medical Device News–March 2010 
FDA Quarterly Briefing–April 2009
Fundamentals of Nanotechnology 
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
International Patent Law 
Introduction to cGMP System-Based Audits
Investigation of Microbial Contamination in Sterile and Non-Sterile Products
IQ, OQ, PQ
ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies
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
Medical Device Regulatory Compliance 
Medical Devices: Strategies for Getting to and Staying on the Market 
Microbiological Control and Validation 
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 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
Recognizing and Preventing Data Integrity Issues
Risk Hazard Assessment for Validation - ISO 14971
Risk Management Today: Complying with the ISO 14971: 2007 Standard 
Root Cause Investigation for CAPA
Safety Assessment of Cosmetic Ingredients and Formulations–An Introduction
Sterilization Technologies and Process Validation 
Tactics to an Effective FDA Submission
The Coming Medical Device Revolution
Updates on Process Validation for Medical Devices…New Approaches and Practice
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