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Physical Seminar- Integrating a Quality Management System and Risk Management for Medical Devices

  January 14, 2011  

ComplianceOnline, SHERATON DFW AIRPORT HOTEL 4440 W. John Carpenter Freeway Irving, TX- 75063

NOTE: Use This Promocode ( 117660 ) To Get 10% Discount. 

Course Description

Medical device manufacturers implement a Quality Management System (QMS) as part of the regulatory requirements. For products marketed in the EU and Canada, manufacturers use ISO 13485. For products marketed in the US, the requirement is FDA QSR. Both systems stem from ISO 9001 concepts. A critical element of medical device quality is Risk Management. The basic standard is ISO 14971.

This 2 days ComplianceOnline seminar covers the essential elements of a medical device quality management system involved in creating an effective Risk Management system. Using ISO 13485 as a model, the seminar covers the QMS essentials that have the most direct impact on Risk Management. These QMS activities includeproduct planning, design and development, supplier management, process validation, customer complaints, internal quality audits, corrective action, preventive action, and post-market surveillance. In addition, the seminar clarifies the requirements for verification and validation. The material compares and contrasts ISO 13485 and FDA QSR requirements

ISO 14971 specifically covers Risk Management activities for medical devices. This standard, recognized by the EU, Canada, and the US, provides the framework for framework for Risk Management. The training takes the participants through the requirements of the standard with a focus on both effective implementation and integration into the QMS. Participants will learn the skills from establishing a risk matrix for your product to implementing post-surveillance monitoring. The seminar discusses tools for Risk Management including: FMEA (Failure Modes and Effects Analysis), FTA (Fault Tree Analysis, and HACCP (Hazard Analysis and Critical Control Points).

Topics include the Risk Management elements of the US, EU, and Canadian regulatory systems. These include risk classification for medical devices, complaint management, and adverse event reporting. In addition, the training discusses the Global Harmonization Task Force (GHTF) guidance document, Implementation of Risk Management Principles and Activities within a Quality Management System.



Course Outline

Day One - Quality Management Systems for Medical Devices

Day Two - Risk Management Systems for Medical Devices

Day 1 - Morning Session

Fundamentals of a QMS : Rationale, Systems approach, Process approach, Documentation, Statistical techniques

Fundamentals of Risk Management : Risk management as a process, Components of risk (severity and probability), Criteria for acceptable risk

Product Planning :

  • Quality plans
  • Verification and validation
  • Monitoring, inspection, and test activities


Design and Development :

  • Planning
  • Design inputs and outputs
  • Design verification and validation


Supplier Management :

  • Supplier evaluation
  • Supplier selection (applying Risk Management)
  • Component specification
  • Acceptance activities


Process Validation :

  • When a process requires validation
  • Data requirements for a validated process
  • Handling changes in a validate process
  • Validated processes as a source of product risk


Day 1 - Afternoon Session

Customer Complaints :

  • Complaint definition
  • Complaint classification
  • Linking complaints to adverse event reporting
  • Linking complaints to corrective action


Internal Quality Audits :

  • Auditing risk based QMS elements
  • Linking quality audits to corrective action


Corrective Action & Preventive Action (CA & PA) :

  • Distinguishing among CA & PA
  • Corrective action as the basic improvement activity
  • Corrective action as a risk management activity


Verification & Validation :

  • Understanding the difference between verification & validation
  • Design validation
  • Process validation


Device classification based on risk :

  • US device classes
  • EU device classes
  • Canadian device classes


Adverse event reporting :

  • US reporting requirements
  • EU reporting requirements
  • Canadian reporting requirements


Day 2 - Morning Session

Risk Management Plan :

  • Scope
  • Responsibilities and authorities
  • Risk acceptability
  • Verification
  • Production information collection
  • Post-production information collection


Risk Analysis :

  • Intended use
  • Identifying hazards
  • Identifying risk


Some Risk Analysis Tools :

  • FMEA
  • FTA


Day 2 - Afternoon Session

Evaluating Risk

  • Comparing risk with the Risk Management plan


Risk Control :

  • Option analysis
  • Implementing risk control
  • Residual risk control
  • Risk/control measures


Residual Risk Evaluation :

  • Understanding residual risk
  • Evaluating residual risk
  • Identifying the decision maker


The Risk Management Report :

  • Defining responsibility
  • Contents


Collecting Production Information :

  • Sources of Information
  • Updating the Risk Management File


Collecting Post-Production Information :

  • Sources of Information
  • Updating the Risk Management File




Who Will Benefit?

  • Quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Production Managers
  • Risk Managers
  • Project Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners
  • Quality Engineers
  • Quality Auditors
  • Document Control Specialists
  • Record Retention Specialists


Organized by: ComplianceOnline
Invited Speakers: Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
Deadline for Abstracts: 2011-03-01
$1195.00 Seminar One Registration
E-mail: admin@complianceonline.com
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