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TELECONFERENCE DESCRIPTION |
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Root Cause Analysis (RCA) is the most important tool in device
recall investigations and for preventing the adverse events.
Unfortunately there is substantial misunderstanding of the
limitations of the tool and how to use it correctly. The result
is often wrong judgments, wrong design changes, and wasted
efforts. Doing it right will reduce costs. Using advanced
methods will make a big difference in preventing recalls.
Attend this 90-minute training to learn proven techniques for
root cause analysis and corrective actions from the presenter
with over 25 years hands-on-experience.
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| AREAS
COVERED IN THE SEMINAR |
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Principles of Root Cause Analysis (RCA).
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FDA Quality System Requirements for RCA.
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RCA from the point of view of the system.
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Root Cause Analysis methods.
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Role of RCA in Failure Mode and Effects
Analysis.
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Using Fault Tree Analysis as RCA tool.
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Risk analysis based on RCA.
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Risk reduction based on RCA.
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WHO WILL BENEFIT |
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This webinar will provide valuable assistance to all Medical
Device companies/ manufacturing sites. Those that would benefit
most would be:
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Design engineers
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Product Management
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Production management
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Safety
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Regulatory
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Purchasing & Production
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Quality Assurance staff
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Suppliers
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INSTRUCTOR PROFILE |
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Dev Raheja, is
a respected and sought out expert on medical device and hospital
care safety. He draws on his 25 years of experience as a risk
management and quality assurance consultant to provide medical
device stakeholders with a systematic way to learn the science
of safety and reliability. He uses evidence-based safety
theories and tools taken from the aerospace, nuclear, medical,
and chemical industries to identify the combination of root
causes that result in an adverse event. He applies analytical
tools that can effectively measure efficiency, establish
evidence between Lean strategies and patient satisfaction.
His focus is on using various types of innovations to encourage
a culture conducive to high return on investment. He is the
author of the books Assurance Technologies principles and
Practices, and Safer Hospital Care. He has served as Associate
Professor for the PhD degree in Reliability Engineering at
University of Maryland during 1994-99.
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| REGISTER |
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Registration - Session Only: $299.00
CD Recording Only: $549.00
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Upcoming Teleconferences
Basics of Testing Associated with Sterilization
Validation and Routine Processing
March 1, 2012
Registration - Session Only: $199.00
CD Recording Only: $450.00
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Full-day Virtual Seminar - South Korea:
Navigating the Regulatory and
Clinical Trial Environment
March 1, 2012
Registration - Session Only: $699.00
CD Recording Only: $999.00
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3-hr Virtual Seminar - HIPAA Security Policies
and Procedures: New
Finalized Regulations Bring New Obligations
March 2, 2012
Registration - Session Only: $349.00
CD Recording Only: $699.00
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Predicting Warranty Expense Using Reliability
Analysis Methods
March 5, 2012
Registration - Session Only: $199.00
CD Recording Only: $449.00
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Audit/Inspection Preparedness for Clinical
Research/Site Coordinators
March 6, 2012
Registration - Session Only: $249.00
CD Recording Only: $449.00
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3-hr Virtual Seminar - Medical Device Adverse
Event Reporting and
Vigilance System During Clinical Trials and Post-Marketing: US, EU,
and Canada
March 6, 2012
Registration - Session Only: $449.00
CD Recording Only: $799.00
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Software Verification and Validation Planning
and Implementation
March 6, 2012
Registration - Session Only: $299.00
CD Recording Only: $599.00
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Social Media in a Regulated Environment (for
Financial Services)
March 7, 2012
Registration - Session Only: $199.00
CD Recording Only: $399.00
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Webinar: When Do You Need a 510k?
March 7, 2012
Registration - Session Only: $249.00
CD Recording Only: $449.00
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Method Validation in Drug Development Process -
Common Mistakes
and Issues
March 7, 2012
Registration - Session Only: $249.00
CD Recording Only: $449.00
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Managing Immunogenicity Risk in
Biopharmaceuticals
March 8, 2012
Registration - Session Only: $249.00
CD Recording Only: $499.00
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FDA's Rules for Financial Disclosure in
Clinical Trials Clarified: New
Guidance, Practical Application
March 9, 2012
Registration - Session Only: $249.00
CD Recording Only: $449.00
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Reduce the Risks of Foreign Material
Contamination - A Manufacturer's
Guide in Creating a Foreign Material Control
March 12, 2012
Registration - Session Only: $199.00
CD Recording Only: $449.00
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Validation of Bioanalytical Methods and
Procedures for FDA Compliance
March 14, 2012
Registration - Session Only: $299.00
CD Recording Only: $499.00
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Ethical Hotlines, Whistleblowers and Compliance
with the EU Data Privacy Laws & Regulations
March 15, 2012
Registration - Session Only: $199.00
CD Recording Only: $449.00
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Setting up an Effective Risk Management Program
March 16, 2012
Registration - Session Only: $199.00
CD Recording Only: $449.00
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Understanding Disinfection and Cleanroom
Cleaning in an FDA Regulated Environment
March 16, 2012
Registration - Session Only: $299.00
CD Recording Only: $499.00
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Letter of Credit Terms and Conditions
March 16, 2012
Registration - Session Only: $199.00
CD Recording Only: $449.00
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Doing Business Despite Embargoes and Sanctions:
OFAC Licensing
March 16, 2012
Registration - Session Only: $199.00
CD Recording Only: $399.00
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Full Day Virtual Seminar - US, EU and Japan GMP
Requirements:
Practical ICH Area Differences, Healthcare Authority Inspection
Focus
March 16, 2012
Registration - Session Only: $549.00
CD Recording Only: $999.00
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OSHA Inspections - Avoiding the 10 Most Common
Mistakes
March 19, 2012
Registration - Session Only: $199.00
CD Recording Only: $449.00
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How to Survive a DEA Audit
March 20, 2012
Registration - Session Only: $449.00
CD Recording Only: $649.00
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How to Establish an Effective Good Clinical
Practice in Drugs and
Medical Devices
March 20, 2012
Registration - Session Only: $249.00
CD Recording Only: $399.00
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Project Management to Meet CGMP Requirements
March 20, 2012
Registration - Session Only: $299.00
CD Recording Only: $499.00
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Water System Mythology: Common False Beliefs
for Microbial Control and Monitoring
March 21, 2012
Registration - Session Only: $249.00
CD Recording Only: $499.00
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Implementation of Pharmacogenomics into the
Routine Clinical Laboratory
March 21, 2012
Registration - Session Only: $299.00
CD Recording Only: $499.00
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Best Practices for Maintaining an IND and IDE
Application with the FDA
March 21, 2012
Registration - Session Only: $249.00
CD Recording Only: $449.00
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Foreign Corrupt Practices Act (FCPA) Webinar
March 21, 2012
Registration - Session Only: $149.00
CD Recording Only: $299.00
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Archiving GLP Records: How Archiving Makes or
Breaks the Audit
March 22, 2012
Registration - Session Only: $249.00
CD Recording Only: $499.00
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Medical Device Risk Management Using ISO 14971
March 23, 2012
Registration - Session Only: $299.00
CD Recording Only: $549.00
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Elegant Quality Assurance Practices for Device
Efficacy and Efficiency
Requirements
March 23, 2012
Registration - Session Only: $299.00
CD Recording Only: $549.00
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Environmental Monitoring and Contamination
Control Plan
March 27, 2012
Registration - Session Only: $299.00
CD Recording Only: $499.00
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Laboratory Investigations for Out of
Specification Results
March 28, 2012
Registration - Session Only: $299.00
CD Recording Only: $499.00
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Foreign Manufacturing Facilities - Avoiding
Problems with FDA
March 29, 2012
Registration - Session Only: $299.00
CD Recording Only: $549.00
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INCOTERMS - International Commercial Terms
March 30, 2012
Registration - Session Only: $199.00
CD Recording Only: $449.00
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Full-day Virtual Seminar - Quality Agreements
with Pharmaceutical/
Biologic Manufacturers and the Use of Drug Master Files:
Understanding and
Meeting Your Regulatory and Processing Responsibilities
March 30, 2012
Registration - Session Only: $749.00
CD Recording Only: $1,099.00
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