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2 Day LVC - Better Medical Devices through efficient Risk Management & Risk Analysis
Presented By Complianzworld
Thursday, February 19th at 9:00am EST - Friday, February 20th, 2015
Online sale ends: 02/17/15 at 2:00pm EST
Complianz World
New York, NY 10036
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Description

Better Medical Devices through efficient Risk Management & Risk Analysis: Hands-on Workshop – 2-day In-person- LVC

Location: Attend Live Webinar
Dates: 19-Feb-2015 : 9:00 AM PST
Duration : 720 Mins

Speaker: Dev Raheja , FDA

Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare, medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to come up with elegant solutions using creativity and innovation.

Course Description:

Medical device recalls can cost billions. The number of medical device products affected by recalls hit an eight-quarter high in the second quarter of 2012, exceeding 100 million units. Perhaps most striking is the fact that of the 140 medical device companies affected by recalls in the 90-day period in this quarter, one-third faced multiple recalls. More than 10 million units were affected. It is a reminder that recalls can happen to any company—especially as more and more companies turn to outsourcing [1]. A Division of a highly reputable company paid over 4 billion dollars just to settle 8,000 lawsuits for hip joint device recall which resulted in severe pain and injury to the users from metallic debris generated. In addition, the company paid surgical expenses to those affected.

Reasons to attend:

While most standards are helpful, they can be considered only minimum requirements where self interest prevails. Even in healthcare where compliance to standards is at highest level, more patients die from medical mistakes each week than a jumbo jet crashing each week. Understanding how mishaps can happen before they happen and preventing them by design is the key. This 2-day workshop will provide the attendees with best practices for proactive risk management. The direct financial costs may include:

  • Cost of product removal, investigation, and corrective medical services to recover from harm
  • Administration of the recall (including legal fees, communication with patients and hospitals, contractor fees, and higher insurance costs)
  • Product replacement and priority shipping costs
  • Shutdown of the facility for the duration determined by the FDA (a company was not allowed to sell its radiology system for two years, a handy-wipe company was shut down for three months)

AGENDA:

Day 1:

Registration

REGULATORY REQUIREMENTS ON  RISK MANAGEMENT

  • Risk Management Principles
  • Developing Risk Acceptance Criteria
  • Risk Analysis Using the Preliminary Hazard Analysis
  • Assessing the Risk
  • Mitigating risks using world class practices
  • Risk Evaluation
  • Managing residual risks

Break

PARADIGMS FOR EFFECIENCY AND COST REDUCTION

  • Management Responsibility
  • Theory of Profound Knowledge
  • Six Most Widely Used Paradigms
  • Elegant Problem Solving
  • Always Compare Life Cycle Costs to See the Cost Savings
  • Case Histories of Efficient Management

Lunch

EFFICIENCY IN RISK ANALYSIS

  • Identifying Known Risks
  • Conducting Preliminary Hazard Analysis (PHA) to Assess Risks
  • Conducting Failure Mode and Effects Analysis
  • Group Exercise on Preliminary Hazard Analysis
  • Group Exercise on Failure Mode and Effects Analysis

Break

IDENTIFYING UNKOWN RISKS

  • Negative requirements Analysis for Worst Case Scenarios
  • Fault Tree Analysis
  • Customer Surveys
  • Analysis of Manufacturing Processes
  • Group Exercise on Fault Tree Analysis

Day 2:

RISK MANAGEMENT PLAN

  • FDA Guidance on Risk Management Plan
  • Components of Risk Management Plan
  • Level of Details Needed
  • Integration into Risk Management File
  • Time Schedules
  • Controlling Plan Changes
  • Integrating Plan into Product Development
  • Auditing Risk Management File

Break

RISK CONTROL AND RISK EVALUATION

  • FDA Risk Control Protocols
  • Thorough Risk Control Strategies
  • Risk Evaluation Process When in Doubt
  • Examples of Risk Elimination Altogether
  • Examples of Fail Safe Control
  • Examples of Effective Training
  • Group Exercise on Risk Control

Lunch

VERIFICATION AND VALIDATION OF RISK CONTROLS

  • FDA Requirements for Documentation
  • Verification of Risk Control During Design and Manufacturing Planning
  • Validation of Design Risks
  • Validation of Manufacturing Risks

Break

RISK MANAGEMT REPORTS

  • Contents of Reports
  • Limitations and Assumptions
  • Addressing Newly Discovered Risks
  • Summary of the Controls
  • Summary of Residual Risk Actions

Who can Benefit from this Program

  • Senior management
  • All hardware and software engineers
  • All technical managers
  • Regulatory affairs professionals
  • Marketing Managers
  • Service managers
  • Project Managers and engineers
  • Quality Assurance staff
  • IT professionals looking to make the design process efficient

Please Click  hear  for More  Information

To Enroll for This Program today  please click hear

Thank you & Regards,

Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

Call us at this Toll Free number: +1-866-978-0800

http://www.complianzworld.com


Presented By

9:00am to 2:00pm
Doors open at 9:00am

General Admission: $799.00

Age
21+

Complianz World<br> New York, 10036

+1-866-978-0800

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