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ComplianceOnline, SHERATON DFW AIRPORT HOTEL 4440 W. John Carpenter Freeway Irving, TX -75063
2011-02-28
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 : 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
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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
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Organized by:
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ComplianceOnline |
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Invited Speakers:
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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.
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Deadline for Abstracts:
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2011-02-28
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Registration:
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$1195.00 Seminar One Registration
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E-mail:
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admin@complianceonline.com
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