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Quality Audits for the Medical Device Industry

in Washington D.C. from 25-Jan-2018 - 26-Jan-2018

Course "Quality Audits for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Day 1 Schedule
Lecture 1: Audit requirements in QMS standards
• ISO 13485:2003
• ISO 13485:2016
• ISO 14971:2007 & EN ISO 14971:2012
• ISO 19011:2011
Lecture 2: Setting Up the Audit Program
• Contents of the audit SOP
• Developing and maintaining the audit schedule
• Determining audit areas - process, procedure, or department
• Tracking audit findings to closure
• Documenting corrective action
• Scheduling re-audits
Lecture 3: Auditor Qualifications and Assignment
• Determine auditor competence requirements
• Qualifying auditors - Training and experience
• Assigning auditors - Skill and knowledge
• Assigning auditors - Avoiding conflicts of assignment
• Evaluating auditor performance
Lecture 4: Planning the Audit
• Auditor assignment
• Audit scope
• Audit criteria
• Audit plan
Lecture 5: Conducting the Audit
• Audit methods
• The backward tracing process audit
• Reviewing records
• Interviewing
• Quality policy and quality objectives
• Collecting audit evidence
Lecture 6: Audit Sampling Plans
• Judgement samples
• Statistical samples
• Common statistical sampling plans
Lecture 7: Reporting the Audit
• Writing findings - positive and negative
• Scoring audits - Using the MDSAP method
• Writing audit conclusions
• The role of the audit report
Day 2 Schedule
Lecture 1: Conducting Second Party Audits
• Preparing for the audit
• Logistics
• Audit scope
• Performing the audit
• Writing the audit report
• Documenting the need for corrective action
Lecture 2: Being Audited (2nd and 3rd party)
• Customer audits
• Notified Body audits
• EU Unannounced audit program
• FDA Inspections
Lecture 3: Responding to audit nonconformances
• Determining the cause
• Extending the corrective action
• Changes - procedures and training
• Evaluating the impact of changes
• Determining effectiveness
Lecture 4: Reporting to Management Review
• Quality audit as a management tool
• Summarizing audit results
• Determining QMS effectiveness
• Determining any need for change
• Management Review agenda and report
Dan O'Leary
President, Ombu Enterprises
Dan O'Leary is 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 certified by APICS in Resource Management.

Type of Event: Courses
Event Date: 25-Jan-2018 to 26-Jan-2018
Language: English
Attendance Fee: $1,295.00 
Deadline: 23-Jan-2018
Event Organiser: Netzealous - GlobalCompliancePanel
  • ISO
  • training
  • standards
  • Six Sigma
  • samples
  • resource management
  • medical devices
  • mathematics
  • logistics
  • FDA

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