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Knowledge, a Way Forward

2-day In-person Seminar:

Effective and Efficient Internal and Supplier Quality

System Auditing for Medical Devices

Los Angeles, CA

October 22nd & 23rd, 2015

9:00 AM to 6:00 PM

Course "Effective and Efcient Internal and Supplier Quality System Auditing for Medical Devices " has been
pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertication upon full

Betty Lane
Founder and President, Be Quality Associates, LLC
Betty Lane has over 30 years' experience in Medical Device quality assurance and regulatory affairs. She is the founder and
President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and
diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business
in compliance with FDA and ISO 13485 requirements, while having a cost-effective Quality Management System. Her
background in digital systems engineering enables her to facilitate implementation of design controls and software validation.
Her areas of expertise include training, auditing, supplier management, document and records management, design controls,
and software validation.

Do you want to understand how to do efcient and effective internal and supplier audits that meet all the requirements of your
external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents
for medical device quality management systems and are tired of wading through all the regulatory language they contain.
This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits.
This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you
will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP)



Knowledge, a Way Forward



Course Overview

The purpose of auditing

Introductions - interview exercise

The difference between internal and external audits

Overview of ISO 13485 and FDA Quality System

Audit Planning

Regulation (cGMP)

The Audit Manager

How to create an audit schedule

Tracking audit performance

General Quality system requirements for Medical


The audit process and our procedures

Document and Records Control

Management's Responsibilities including

Management Review
Provision of Resources including human resources,

training, facilities and work environment

Provision of Products and Services: How do you

Audit Preparation & Planning

Check lists

Audit Notice

Opening Meeting

The audit

Specic items to check in various areas

Comments and nonconformities

Audit Report

How to say things properly on audit paperwork

provide products and services to your customers

Exercise on writing nonconformities
Exercise on Provision of Product and Services -

what issues has you company had

Monitoring, Measurement and Improvement: How

Corrective Actions

Closing the audit

Practice Audits

to we make sure everything is running well or x it if

it is not (including product and process monitoring,
complaints, Corrective and preventive action and

What the FDA can ask for concerning internal and

supplier audits

internal audits)

Exercise on application of requirements



Why you should attend

Internal and supplier audits are effective and efcient ways for your company to stay in compliance with ISO 13485 and or FDA Quality
System Regulation requirements. They help you spot problems or potential problems before they become large issues and before they are
found by external auditors. Therefore, it is of great benet to companies to make sure their internal and supplier audits are trained in
applicable standards, regulations, and the auditing process. It is also important that you establish and maintain an audit program that
covers all requirements, both external and internal. Effective internal and supplier audits make good business sense.



Pricing List

Knowledge, a Way Forward

Group participations

Price for One Delegate pass Price: $ 1,295.00

Register now and save(Early Bird) $200.(Early Bird) Price

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**Please note the registration will be closed 2 days (48 Hours) prior to

2 Attendees to get offer


3 to 6 Attendees to get offer


7 to 10 Attendees to get offer


10+ Attendees to get offer


the date of the seminar.

What you will get

Learning Objectives
Participation certificates

Payment Option
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Visa/Master/American Express card click on the
register now link

Interactive sessions with the US expert

Post event email assistance to your queries.

Check: Kindly make the check payable to

NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,

Special price on future purchase of web

Fremont, CA 94539, USA

based trainings.
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Networking with industry's top notch professionals


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NetZealous LLC, DBA GlobalCompliancePanel

Look forward to meeting you at the seminar

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA


Toll free: +1-800-447-9407

Fax: 302 288 6884