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34594 Conferences

Internal Audit Checklist for Medical Devices | Quality Audit

Added by globalcompliancepanel on 2017-11-19

Conference Dates:

Start Date Start Date: 2018-01-25
Last Date Last Day: 2018-01-26
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2018-01-23

Conference Contact Info:

Contact Person Contact Person: Event manager
Email Email:
Address Address: Embassy Suites Boston Logan Airport, 207 Porter St, Boston, MA, 02128, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

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
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

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