Applying GMP Quality Principles To Establish A Reduced Testing Program Webinar by Compliance2go

Document Sample
Applying GMP Quality Principles To Establish A Reduced Testing Program Webinar by Compliance2go Powered By Docstoc
					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
Minute)



                                         Description

                                         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.
        Laboratory Analyst
        Cost Accounting

                                         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
        testing
       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
        plan




About Speaker:

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. 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 support@compliance2go.com or call us at 877.782.4696

https://www.compliance2go.com/index.php?option=com_training&speakerkey=2&productKey=7

				
DOCUMENT INFO
Description: This webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices. Reduced testing will be viewed from current industry practice, 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 principles and increase in understanding of the topics