This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action.

1. 2-day In-person Seminar:
Knowledge, a Way Forward…
Internal Auditing for the Medical Device Industry
Philadelphia, PA
June 30th & July 1st, 2016
9:00 AM to 6:00 PM
Joseph Azary
Director Regulatory and Quality at Sekisui American Diagnostica
Joseph Azary has over 25 years of quality and
regulatory experience in the medical device industry. Joseph is
currently the Vice President of Quality Assurance & International
Regulatory Affiars at Z-Medica, LLC.
Joseph Azary has worked for companies such as US Surgical (now part
of Covidien), Johnson & Johnson, Fujifilm Medical, and Sekisui
Diagnostics. Mr. Azary was a consultant for 10 years working with
approximately 180 companies. He has sold his consulting company,
Azary Technologies in 2008.
Joseph has a bachelors degree in Biological Science from University of
Connecticut and a Masters of Business Administration (MBA) in public
health from Sacred Heart University. Joseph is an ASQ Certified Quality
Auditor (CQA).
Global
CompliancePanel
Overview:
This course provides an overview of internal auditing requirements and
techniques for medical device companies as a method for risk
management and quality improvement.
The course will cover auditing requirements, audit planning, preparation,
knowledge, auditor skills, interviews, documents and records review,
objective evidence, audit report writing and corrective action.
(Without Stay) Price: $1,295.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Price

2. Global
CompliancePanel
AGENDA:
Day One Day Two
2-day In-person Seminar:
Internal Auditing for the Medical Device Industry
Lecture 1:
 Overview of an auditing program, principles of
quality management systems and how they
related to auditing, benefits of auditing, and
what is auditing.
Lecture 2:
 Types of audits, auditor qualifications, ethics,
responsibilities, audit phases, audit planning,
and scheduling.
Lecture 3:
 Conducting audits, interview techniques,
objective evidence, data collection, tracing, use
of checklists, and reviewing documents and
records.
Lecture 4:
 Conducting process audits, running closing
meetings, audit report writing, corrective
actions, and improvement
Lecture 1:
 Overview to auditing to ISO 13485 and FDA
QSR. Global differences which affect auditing
approaches, auditing document control and
record keeping, management responsibility,
and resource management.
Lecture 2:
 Auditing order handling, design control,
purchasing, and supplier controls.
Lecture 3:
 Auditing production, validation, and
preservation. inspection and testing, control of
test equipment, customer property, and
sterilization
Lecture 4:
 Auditing customer feedback, internal auditing
programs, complaints, recalls, adverse events,
and corrective and preventive action.
Attendees should attend this seminar for risk
management and improvement purposes to
identify weaknesses, problems, compliance risks,
and improvement opportunities.
 Quality Manager
 Quality Associate
 Quality Engineer
 Quality Technician
 Regulatory Associate
Who will benefit:Why should you attend:

3. Global
CompliancePanel
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information.
Look forward to meeting you at the seminar
GlobalCompliancePanel
What You will get
Special price on future seminars by
GlobalCompliancePanel.
Networking with industry's top notch professionals
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1 Learning Objectives
2 Participation certificates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
based trainings.
Special price on future consulting or expertise
services.
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Seminar Kit – includes presentation handout,
ID card, brochure, trainings catalog, notepad
and pen.
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Contact Information: Event Coordinator
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Fremont, CA 94539, USA
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
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2-day In-person Seminar:
Internal Auditing for the Medical Device Industry