Establishing a Reduced Testing Process for Incoming Materials
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
Quality management system
Material and laboratory supplies
Taking corrective action
Working with the supplier
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
Cost Accounting Professionals
External Auditing Team
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.