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Who should attend Establishing a Reduced Testing Process for Incoming Materials - By Compliance Global Inc.
QA, QC Professionals, Laboratory Personnel, Receiving Warehouse, Cost Accounting Professionals, External Auditing Team
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Seminar Summary:

This webinar will help to increase understanding of requirements, how to maintain compliance and increase quality. (see full course description)

 
 
 

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Training Course Syllabus:


Establishing a Reduced Testing Process for Incoming Materials

Overview

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

Areas Covered in this Webinar

Introduction
Quality management system
Material and laboratory supplies
Material validation
Taking corrective action
Working with the supplier
Supplier disqualification

Learning Objectives

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
A brief overview of supplier selection and qualification
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
Going beyond reduced testing to supplier certification
FDA compliance training activities related to reduced testing

Who Will Benefit

QA, QC Professionals
Laboratory Personnel
Receiving Warehouse
Cost Accounting Professionals
External Auditing Team

Speaker Profile

Howard Cooper has over 40 years of experience facing the challenges of managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, & food industries. He started his quality career at Anheuser-Busch as a quality management trainee which exposed him to an advanced and preventative approach toward quality. He then took this experience to the medical device industry when the medical device amendments of 1976 were being written and promulgated. He quickly distinguished himself as a change agent and a forward thinking quality leader.

Mr. Cooper built on this experience to set up a pharmaceutical /medical device and combination product quality system. Since that time, he has worked with incubators, small companies, and large international corporations in the quality and regulatory affairs. In 2004, he became an independent consultant continuing his work to manage, develop, and implement quality. Mr. Cooper particularly enjoys sharing his experience with others to further develop them for successfully running quality operations.

Seminar Summary:

This webinar will help to increase understanding of requirements, how to maintain compliance and increase quality. (see full course description)

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