Establishing a Reduced Testing Program for Pharmaceutical & Medical Device Components

Live Webinar on

Establishing a Reduced Testing Program for Pharmaceutical &
Medical Device Components
Date & Time:


Thursday, September 1, 2011
10:00 AM PDT | 01:00 PM EDT

Register Now

Duration: 90 Minutes
Instructor: Howard Cooper
Location: Online
Price : $245.00 (for one participant)

Instructor Profile:
Overview:
Howard Cooper
Reduced testing test permits a medical product manufacturer to
President, EQACT, Inc.
reduce testing of incoming components provided there are adequate
controls on specification control, material qualification, supplier
Howard enjoys sharing his 30 years
qualification & monitoring, material validation, and collaborative
plus experience in starting up,
testing.
developing, implementing,

managing, and remediating
Industry practice in the performance of reduced testing has resulted
pharmaceutical and medical device
in new and modified expectations and requirements.
quality systems. He has a BS in

Biology/Chemistry and Political
Science as well as work toward an
Why should you attend:
MBA. His ability to quickly learn the
Only you can determine the need to attend this webinar. I would like
technology is demonstrated by his
to offer a suggestion. Why not review the principles explained in this
success in applying quality
informational packet and then compare your system structure to the
assurance principles to a wide range
of pharmaceuticals and medical
elements outlined here. If your system includes all of these
devices. He is a Certified Biomedical
elements, that's great. Then, join us to learn a new perspective.
Auditor (CBA), Certified Quality
However, if you see some potential vulnerability, please join us to
Manager (CQM), and Quality Auditor
learn more and gain insight for improving your reduced material
(CQA). His technical education is
testing program.
further complemented by his Political

Science degree helping him
This course will help you understand the lifecycle for the reduced
understand the regulatory process;
testing of pharmaceutical and medical device components. This
his work toward an MBA provides
business insight. He is a member of
lifecycle begins by explaining the steps of a successful reduced
ASQ, PDA, AAMI, RAPS, and SQA.
testing program that include material qualification, general supplier
He strongly believes that Quality is
qualification, supplier qualification for reduced testing, establishing
very influential in shaping successful
criteria for sampling, role of validation, the role of the laboratory, test
operations. He knows how to use his
methods, comparing analytical results, analyzing the Certificate of
leadership abilities to build
Analysis (COA), and monitoring to ensure continued compliance with
organizational relationships that
the regulations. This understanding of the lifecycle will help you
make systems operate effectively as


confidently present arguments to management for establishing,
well as to develop and empower
people. ...more
designing, training and implementing, and managing the reduced
testing process.

Suggest a Topic
More Webinars
Areas Covered in the Session:
Your Necessity is our Priority
l
A Brief Quality Lesson
l
Defining the Reduced Testing of Components Environment
l
Regulatory Requirements and Current Industry Practices for
Reduced Testing.
l
Advantages and Disadvantages of Reduced Testing

l
Players, Roles, And Responsibilities-Interdepartmental roles in
establishing and maintaining a reduced testing program.
l
A study of the reduced testing lifecycle in graphical format ,
including specification control, material qualification,
researching and selecting suppliers, supplier auditing
(including selection of audit team members) and qualification,
corrective actions, handling certificates of analysis, maintaining
supplier quality and control, supplier change control, and
handling problems suppliers.
l
A Risk Based Sampling Plan To Determine Sample Size and
Frequency
l
Planning for Implementing a Reduced Testing Plan
l
Implementing a Reduced Testing Program
l
Action Steps
l
Maintaining The System
Click here to register for this webinar
Who Will Benefit:

---

l
Material Laboratory Managers & Personnel
l
Incoming Warehouse
l
Purchasing & Production
l
Quality Assurance Managers
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
About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.
GlobalCompliancePanel
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801

Phone: 800-447-9407 or
Fax your PO to: 302-288-6884
If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

---