Price: $1,295.00 (Seminar Fee for One Delegate) Register for 5 attendees Price: $3,885.00 ...
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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.
Who Will Benefit:
Day 1 Schedule
Lecture 1: Audit requirements in QMS standards
Lecture 2: Setting Up the Audit Program
Lecture 3: Auditor Qualifications and Assignment
Lecture 4: Planning the Audit
Lecture 5: Conducting the Audit
Lecture 6: Audit Sampling Plans
Lecture 7: Reporting the Audit
Day 2 Schedule
Lecture 1: Conducting Second Party Audits
Lecture 2: Being Audited (2nd and 3rd party)
Lecture 3: Responding to audit nonconformances
Lecture 4: Reporting to Management Review
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: WILL BE ANNOUNCED SOON
Price: $1,295.00 (Seminar Fee for One Delegate)
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Until December 10, Early Bird Price: $1,295.00 From December 11 to January 23, Regular Price: $1,495.00
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Sponsorship Program benefits for “Quality Assurance Auditing for FDA Regulated Industry” seminar
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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