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Quality Audits for the Medical Device Industry


Thursday, March 2, 2017 at 8:30 AM - Friday, March 3, 2017 at 4:00 PM (PST)

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Ticket Type Remaining Sales End Price Fee Quantity
Single Registration
Special Group Discount 2 Attendees - Get 10% off 3 to 5 Attendees - Get 20% off 5+ Attendees - Get 30% off
28 Tickets Ended $1,400.00 $61.95

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Event Details

Quality Audits for the Medical Device Industry


   Daniel O'Leary - President, Ombu Enterprises, LLC





Course Description
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 review the various kinds of audits to understand their role. Internal quality audits (1st party) help a company evaluate itself. Customer/supplier audits (2nd party) 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. This includes the two major elements. First, is a plan to schedule, conduct, report, and close audits. Second, is the assignment of qualified people based on skill and considerations of conflict of interest. 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 and contributors to the nonconformity. These methods are important in all three audits types. The workshop provides methods and exercises for these important activities.Management needs to understand the results from each audit type as part of Management Review. The presentation should use statistical methodology to analyze quality audit reports. The workshop discusses the role of management review and helps identify the appropriate statistical methodology.

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 can Benefit

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

Note: Use Promo code HJQDZ and get 10% off on registration (Valid till MARCH 31st 2017)
Have questions about Quality Audits for the Medical Device Industry? Contact onlinecompliancepanel

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When & Where

San Diego

San Diego

Thursday, March 2, 2017 at 8:30 AM - Friday, March 3, 2017 at 4:00 PM (PST)

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Online Compliance Panel creates and delivers comprehensive industry relevant training sessions. These sessions are simple, interactive and cost effective. We are a predominantly web based information exchange forum. Live interactions on compliance training make the process holistic and effective. Online Compliance Panel largely emphasizes in offering regulatory compliance training to compliance professionals on varied topics. These primarily include risk management, quality management, corporate compliance and other regulatory compliances. Some of our primary areas of focus include advancement and updates in regulatory compliance, best practices and market trends.

We strive to incorporate high standards in developing a culture facilitating exchange of ideas resulting in functional excellence. Online Compliance Panel believes in nurturing ideas and thought processes through innovative e-learning methodologies. Our products and services are designed to offer customized solutions to industry and market. We bridge the gap between experience and knowledge thus delivering original and creative content.

Our objectives of employing interactive mediums ensure effective communication and mutual exchange of ideas. Online Compliance Panel closely follows best practices and regulatory trends in the global compliance scenario. We also observe and communicate trends witnessed in FDA, ISO regulations, process and design validation. All updates and additions to important laws can be accessed by our customers in real time.

Our mission is to empower compliance professionals through effective online training sessions. Our world class training methodologies stem from comprehensive understanding of client requirements. The content conforming to FDA and ISO standards is developed by well qualified and experienced industry leaders. Our offerings will exceed expectations and add value to your investment.

The content in various categories such as medical devices, pharmaceuticals and biotechnology will raise the bar in terms of quality already on offer .We hope to contribute to the creation of responsible organizations creating benchmarks in quality, integrity and transparency.

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Quality Audits for the Medical Device Industry
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