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Follow on Google News | Establishing a Reduced Testing Process for Incoming MaterialsThis webinar will discuss current regulatory and quality requirements for reduced testing of components used in pharmaceuticals and medical devices.
By: OnlineCompliancePanel LLC Description: The first step in reduced testing is to qualify the supplier using the supplier qualification process. This webinar will review the supplier qualification process. The sequential steps for establishing reduced testing program will be presented in a logical way using graphics including flowcharts. Guidance and recommendations for assessing the data to qualify a supplier for reduced testing will be discussed. This will be followed by describing the monitoring process to assure the required reliability. Considerable use of graphics will be used. Additionally, the basic quality principles that apply to reduce testing will be emphasized. Why Should you Attend: To increase understanding of requirements To learn how to maintain compliance and increase quality To gain insight for improving supplier quality while reducing cost and gaining resources that can be applied to quality, product, and process quality. Objectives of the Presentation: Introduction The role of materials in the achievement of product quality and customer satisfaction Similarities and differences of regulatory requirements for pharmaceutical, medical device, dietary supplements and food. Types of quality certificates A brief overview of supplier selection and qualification Material and laboratory qualification Material validation Collaborative testing between you and your supplier Factors to consider in establishing the sample plan to reduce risk The sampling plan calculation based primarily on risk factors Monitoring analytical results Taking corrective action Working with the supplier Supplier disqualification Going beyond reduced testing to supplier certification FDA compliance activities related to reduced testing Who can Benefit: QA, QC Laboratory Receiving warehouse Cost Accounting External Auditing Quick Contact http://www.onlinecompliancepanel.com/ End
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