2014 - Establishing a Reduced Testing Process for Incoming Materials

Instructor: Howard T Cooper
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:
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