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Internal Audit Checklist for Medical Devices | Quality Audit

Start Date:
Thursday, 25 January, 2018
End Date:
Friday, 26 January, 2018 6:00pm
Dermatology, Nephrology, Gastroenterology, Immunology, Pain Management, Hepatology, Cardiology, Endocrinology

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. Overview: 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 typesLearn the difference among audit methods (system, product, process, etc.)Understand audit scheduling and methods to establish and update the scheduleRecognize the role of auditor competency and how to determine itRecognize which audits an auditor could conduct and which ones to avoidUnderstand the role of correction and corrective action related to an audit nonconformanceDevelop an effective approach for reporting at Management Review Who Will Benefit: Audit ManagerLead AuditorsAudit Team MembersManagement RepresentativeQuality Assurance ManagersQuality EngineersRegulatory Affairs ManagersSupplier Management and PurchasingSupplier Quality Engineers Agenda: Day 1 Schedule Lecture 1: Audit requirements in QMS standardsFDA QSRISO 13485:2003ISO 13485:2016ISO 14971:2007 & EN ISO 14971:2012MDSAPISO 19011:2011Lecture 2: Setting Up the Audit ProgramContents of the audit SOPDeveloping and maintaining the audit scheduleDetermining audit areas - process, procedure, or departmentTracking audit findings to closureDocumenting corrective actionScheduling re-auditsLecture 3: Auditor Qualifications and AssignmentDetermine auditor competence requirementsQualifying auditors - Training and experienceAssigning auditors - Skill and knowledgeAssigning auditors - Avoiding conflicts of assignmentEvaluating auditor performanceLecture 4: Planning the AuditAuditor assignmentAudit scopeAudit criteriaAudit planLecture 5: Conducting the AuditAudit methodsThe backward tracing process auditReviewing recordsInterviewingQuality policy and quality objectivesCollecting audit evidenceLecture 6: Audit Sampling PlansJudgement samplesStatistical samplesCommon statistical sampling plansLecture 7: Reporting the AuditWriting findings - positive and negativeScoring audits - Using the MDSAP methodWriting audit conclusionsThe role of the audit report Day 2 Schedule Lecture 1: Conducting Second Party AuditsPreparing for the auditLogisticsAudit scopePerforming the auditWriting the audit reportDocumenting the need for corrective actionLecture 2: Being Audited (2nd and 3rd party)Customer auditsNotified Body auditsEU Unannounced audit programMDSAPFDA InspectionsLecture 3: Responding to audit nonconformancesDetermining the causeExtending the corrective actionChanges - procedures and trainingEvaluating the impact of changesDetermining effectivenessLecture 4: Reporting to Management ReviewQuality audit as a management toolSummarizing audit resultsDetermining QMS effectivenessDetermining any need for changeManagement Review agenda and report SpeakerDan O'LearyPresident, 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, DCDate: January 25th & 26th, 2018 and Time: 9:00 AM to 6:00 PMVenue: Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Highway Arlington, VA 22202 USA Price: 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: $1,495.00Register 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%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminarAt 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. For More Information- Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:6.0pt;mso-para-margin-left:0in;line-height:110%;mso-pagination:widow-orphan;font-size:10.0pt;font-family:"Calibri",sans-serif;mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}


Courtyard Arlington Crystal City/Reagan National Airport 2899 Jefferson Davis Highway Arlington,
22202 USA

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
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