Live Webinar on : Applying GMP Quality Principles To Establish A Reduced
Testing Program - Thursday, 18 August 2011, 01:00 PM EST / 10:00 AM PDT (90
This webinar will discuss current regulatory and
quality requirements for reduced testing of components
Get 15 % Discount as a early bird used in pharmaceuticals and medical devices. Reduced
registrations. Use Promo Key : testing will be viewed from current industry practice,
CGO15 the regulations, and quality principles. The reduced
testing lifecycle we studied and reviewed. This includes
such topics as component specifications, material
qualification, supplier auditing and qualification,
collaborative laboratory testing, certificates of analysis,
material validation sampling, analyzing testing,
qualification, and disqualification. Examples of systems
will be shown. This webinar will primarily use
graphics, especially flowcharts, to demonstrate the
Who will benefit principles and increase in understanding of the topics.
Quality Control As industry has been looking to reduce costs, improve
Laboratory Manager efficiency, the FDA has begun to more closely scrutinize
Warehousing Purchasing the industry effort to make certain that the above
Managers mentioned controls are in place. In this effort the FDA is
Procurement Managers focusing on supplier control and sampling issues.
The benefits of systematic reduced testing program
Pricing include increased compliance, smaller inventory cycles,
less testing, less handling, and increased productivity
Live ( Single registration ) : $189.00 and efficiency.
Group ( Max 10 Attendee): $499.00
Reduced testing test permits a medical product
manufacturer to reduce testing of incoming components
provided there are adequate controls on specification
Why should you attend:
To reduce costs and increase efficiency in the handling
of incoming materials and components.
To gain knowledge applicable to the control and
qualification of suppliers that will increase compliance
and improve efficiency
To understand the compliance and quality
requirements for reducing incoming material testing on
pharmaceutical and medical device components.
Areas Covered in the Session:
Advantages and disadvantages of reduced
Basic review of quality systems.
Brief review of regulatory requirements.
Differences between suppliers and contractors.
Interdepartmental roles in establishing and
maintaining a reduced testing program.
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.
Logistics of implementing a reduced testing
Howard enjoys sharing his 30 years plus experience in
starting up, developing, implementing, managing, and
remediating pharmaceutical and medical device quality
systems. One of his favorite areas is material and
supplier control from which he receives great
satisfaction in applying his knowledge for
improvement.Ã‚Â He has a BS in Biology/Chemistry
and Political Science as well as work toward an MBA.
His ability to quickly learn the technology is
demonstrated by his success in applying quality
assurance principles to a wide range of pharmaceuticals
and medical devices. He is a Certified Biomedical
Auditor (CBA), Certified Quality Manager (CQM), and
Quality Auditor (CQA). His technical education is
further complemented by his Political Science degree
helping him understand the regulatory process; his
work toward an MBA provides business insight. He is a
member of ASQ, PDA, AAMI, RAPS, and SQA.He
strongly believes that Quality is very influential in
shaping successful operations. He knows how to use his
leadership abilities to build organizational relationships
that make systems operate effectively as well as to
develop and empower people..
For any assistance contact us at email@example.com or call us at 877.782.4696