Internal Audit Checklist for Medical Devices | Quality Audit


25 ene, 2018 – 9:00 A.M. - 6:00 P.M.

(diariamente hasta 26 ene 2018)

2899 Jefferson Davis Highway Arlington, VA 2220...
Arlington, VA 22202 Mapa

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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.


Quality audits are an important element in implementing and maintaining an effective Quality Management System (QMS). Audits are one of the most powerful tools that management has to assure on effective QMS.
In this workshop, participants examine the various types of audits to understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2ndparty) play a role in an effective supplier management program; your company could be the subject of the audit. Independent audits (3rd party) can help provide assurance about the health of a QMS.
This workshop provides the tools to establish and maintain an effective quality audit program for medical device manufacturing. The program includes the two major elements. Develop a plan to schedule, conduct, report, and close audits. Assign qualified people based on training, skill, and conflict of interest considerations. The workshop explains how to implement these quality audit program elements using examples and exercises that help develop the necessary skills.
Another important part of an audit program is responding to audit nonconformances. This includes correction, investigation, and corrective action. An effective audit program determines and eliminates the causes of the nonconformity, corrective action, to prevent recurrence. The workshop provides methods and exercises to for these important activities.
Management needs to understand the results from each audit type as part of Management Review. The workshop presentation should use statistical methodology to analyze quality audit reports. The workshop discusses the role of management review and helps identify the appropriate statistical methodologies for effective communication to management.

Learning Objectives:

• Learn the difference among the audit types
• Learn the difference among audit methods (system, product, process, etc.)
• Understand audit scheduling and methods to establish and update the schedule
• Recognize the role of auditor competency and how to determine it
• Recognize which audits an auditor could conduct and which ones to avoid
• Understand the role of correction and corrective action related to an audit nonconformance
• Develop an effective approach for reporting at Management Review

Who Will Benefit:

• Audit Manager
• Lead Auditors
• Audit Team Members
• Management Representative
• Quality Assurance Managers
• Quality Engineers
• Regulatory Affairs Managers
• Supplier Management and Purchasing
• Supplier Quality Engineers


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.

Location: Washington, DC Date: January 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Highway Arlington, VA 22202 USA


Price: $1,295.00 (Seminar Fee for One Delegate)
Register now and save $200. (Early Bird)
Until December 10, Early Bird Price: $1,295.00 From December 11 to January 23, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)*

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At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO’s of various designations. Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry.
As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory -related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants.
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NetZealous LLC DBA GlobalCompliancePanel
Toll free: +1-800-447-9407
Phone: +1-510-584-9661

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Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Register for 10 attendees Price: $7,122.00 $12,950.00 You Save: $5,828.00 (45%)* Register now and save $200. (Early Bird)

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