Internal Audit Checklist for Medical Devices | Quality Audit

Start Date : January 25, 2018
End Date : January 26, 2018
Time : 9:00 am to6:00 pm

Phone : 800-447-9407
Email : john.robinson@globalcompliancepanel.com

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

Website

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.

 

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:

 

 

Who Will Benefit:

 

 

Agenda:

 

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

 

 

 

Speaker

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, DCDate:  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:

 

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%)*

 

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.

For More Informationhttps://www.globalcompliancepanel.com/control/sponsorship 

 

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Registration Info

Contact us today!

 

NetZealous LLC DBA GlobalCompliancePanel

john.robinson@globalcompliancepanel.com  

support@globalcompliancepanel.com 

Toll free: +1-800-447-9407

Phone: +1-510-584-9661

 Website: http://www.globalcompliancepanel.com

 

Registration Link - http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901429SEMINAR?meetings4docs-January-2018-SEO

 

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Contact the Organizer

Organized by

Organized by globalcompliancepanel

NetZealous DBA as GlobalCompliancePanel ,
NetZealous LLC-GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont,CA 94539, USA

Tel: Event Manager
Mobile: 800-447-9407
Email: john.robinson@globalcompliancepanel.com
Website: http://www.globalcompliancepanel.com/


Event Categories: Cardiology, Critical Care, Dermatology, Emergency Medicine, Endocrinology, Family Practice, Gastro- enterology, General Surgery, Gynecology, Headache / Migraine, Health & Nutrition, Hepatology, Immunology, Infectious Disease, Nephrology, Obstetrics, Ophthalmology, Orthopedic Surgery, Osteopathy, Otolaryngology, Pain Management, Physical Medicine, Plastic Surgery, Podiatry, and Pulmonary Medicine.

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