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Applying GMP Quality Principles To Establish A Reduced Testing Program


Thursday, August 18, 2011
Online Webinar
Houston, United States

http://www.compliance2go.com/index.php?option=com_training&speakerkey=2&productK...

Event Type: Training Course

DESCRIPTION

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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

 

Details:

Reduced testing test permits a medical product manufacturer to reduce testing of incoming components provided there are adequate controls on specification control, material qualification, supplier qualification & monitoring, material validation, and collaborative testing. Industry practice in the performance of reduced testing has resulted in new and modified expectations and requirements.

 

The benefits of systematic reduced testing program include increased compliance, smaller inventory cycles, less testing, less handling, and increased productivity and efficiency.

 

As industry has been looking to reduce costs, improve efficiency, the FDA has begun to more closely scrutinize the industry’s effort to make certain that the above mentioned controls are in place. In this effort the FDA is focusing on supplier control and sampling issues.

Why Should You Attend: 

Reasons for attending this webinar include the following:

 

1. To understand the compliance and quality requirements for reducing incoming material testing on pharmaceutical and medical device components.

 

2. To gain knowledge applicable to  the control and qualification of suppliers that will increase compliance and improve efficiency

 

3. To reduce costs and increase efficiency in the handling of incoming materials and components.

 

FREE HANDOUTS


"Attendees will receive Reduced Testing of Materials for Pharmaceuticals & Medical Devices"

 

Who Will Benefit:

1. Quality Control Laboratory Manager. 2. Warehousing. 3. Purchasing Managers and Procurement Managers. 4. Laboratory Analyst. 5. Cost Accounting.

Areas Covered in the Seminar:

1. Advantages and disadvantages of reduced testing 2. Basic review of quality systems. 3. Brief review of regulatory requirements. 4. Differences between suppliers and contractors. 5. Interdepartmental roles in establishing and maintaining a reduced testing program. 6. 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. 7. Logistics of implementing a reduced testing plan.

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