Design, Planning and Conducting Effective Audits

Live Webinar on

Design, Planning and Conducting Effective Audits
Date & Time:


Tuesday, August 30, 2011
10:00 AM PDT | 01:00 PM EDT

Register Now

Duration: 60 Minutes
Instructor: Mark Roberts
Location: Online
Price : $245.00 (for one participant)

Instructor Profile:
Overview:
Mark Roberts
Internal quality system audits should be viewed as an improvement
Mark Roberts Founder,
tool. Too often due they have a negative connotation and are
Roberts Consulting &
viewed as a necessary evil. Effective audits can comply with the
Engineering
regulations and also be a source of improvement.

Mark Roberts is the head of
Proper planning, staffing, training, and implementation are some of
Roberts Consulting and Engineering
the keys to an effectiveinternalaudit.KnowledgeoftheQSR/ISO
(RCE), a consulting firm specializing
in quality system and sterility
13485 is a must along with the auditing standard 19011. In addition
assurance compliance. He was
to knowing the standards and regulation, effective auditors must
previously the Manager for the
also have good communicationskills.Auditdocumentationandfollow
Western USforTAoeVSAoeD Product
upisalsoakeyfactor.This one hour seminar will provide an
Service. He is an accredited lead
overview for establishment of an effective internal audit program.
auditor and notified body auditor. He

still performs audits for notified
bodies on a contract basis. He has
Areas Covered in the Session:

30 years of experience in the
medical device industry. Prior to
joiningTAoeV he was with Becton
l
Introduction
Dickinson in their corporate offices
l
Applicable standards and Regulations
as manager of quality systems. He
l
Internal vs. External audits
also held various positions in RA/QA,
l
Resources
sterility and engineering for Baxter
l
Training
Healthcare. He is a member of AAMI
l
Planning
and ASQC Biomedical. Publications
l
Audit tools
include portions of the ASQC
l
Communication / Listening Skills
Biomedical Quality Auditor
Handbook. He has also been an
l
Audit Documentation
expert witness on quality systems
l
Follow Up / Effectiveness
and sterility for the FDA. ...more
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Who Will Benefit:
Your Necessity is our Priority
l
RA Directors, Managers and Staff
l
QA Directors, Managers and Staff
l
Internal audit staff
l
All Management Involved in Internal Audits

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel
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