Vendor and Supplier Qualification Program for FDA Regulated Industries
"Vendor and Supplier Qualification Program for FDA Regulated Industries" Seminar has been added to ComplianceOnline.com's offering.
SAN JOSE, CALIFORNIA, UNITED STATES, April 19, 2021 /EINPresswire.com/ -- ComplianceOnline, the world’s leading provider of training for regulated companies will hold a virtual seminar entitled ‘Vendor and Supplier Qualification Program for FDA Regulated Industries.’ The seminar which will be presented by Joy McElroy, will help attendees establish and manage a program that is FDA compliant and robust.
The FDA regulates manufacturers of medical products such as devices, pharmaceuticals, tissue products, and biologics. However, the regulations don’t usually extent to suppliers. Instead, the FDA expects the medical product manufacturer to implement an effective program to qualify and re-qualify suppliers for these regulated industries.
An effective supplier qualification program has some specific elements including determining expectations and requirements, identifying potential suppliers, evaluating them, selecting a supplier, and re-evaluating the selected suppliers. When issues arise, the manufacturer communicates with the supplier and manages corrective action.
The result is a supplier qualification program that address two principal questions:
• Which suppliers are good enough to start doing business with you?
• Which suppliers should continue to do business with you?
This workshop explains an overarching supplier qualification program that is common to FDA regulated medical product manufacturers. It also provides the details of the various program areas such as devices, pharmaceuticals, etc.
An effective supplier qualification uses tools and techniques. The workshop explains particularly relevant tools such as supplier audits, metrics, scorecards, acceptance verification, and corrective action.
Why You Should Attend:
An effective supplier qualification program can prevent problems and save money. The goal is to ensure that competent suppliers provide products and services correctly and on time. This saves cost and helps you provide good products to your customers. In addition, an effective supplier qualification program meets the regulatory requirements; you will not need to worry about an FDA 483 or a Warning Letter. This workshop provides the information you need to establish and manage an effective program.
Participants learn the elements of an effective supplier qualification program for FDA regulated medical products.
• Define a sustainable supplier qualification program
• Understand how to set expectations and requirements
• Learn how to identify potential suppliers
• Understand methods to evaluate potential supplier’s for their ability to meet your requirements
• Know how to select suppliers based on the evaluation
• Learn the requirements to keep records – a key component for FDA compliance
• Learn sound methods to specify the products and services from suppliers
• Understand how to evaluate received products and services, including statistical techniques
• Learn the techniques to monitor and measure supplier performance
• Understand how to re-evaluate suppliers and keep records
• Learn methods to improve or replace poor performers
• Understand supplier qualification tools including audits and performance evaluation
Who Will Benefit:
• Purchasing Managers
• Quality Managers
• Supplier Quality Engineers
• Audit Managers
• Compliance Managers
• Law Department Managers
For more information or to register for this seminar, please click here.
Virtual Training Through WebEx
Date: May 12-13, 2021 (9:00 AM - 5:00 PM EDT)
About the Speaker:
Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt.
With over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.
Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.
In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.
ComplianceOnline is a leading provider of regulatory compliance training programs for companies and professionals in regulated industries. ComplianceOnline has successfully trained over 55,000 professionals from 15,000 companies to comply with the requirements of regulatory agencies. ComplianceOnline is headquartered in Palo Alto, California, and can be reached at http://www.complianceonline.com. ComplianceOnline is a MetricStream portal. MetricStream (www.metricstream.com) is a market leader in Enterprise-wide Governance, Risk, Compliance (GRC), and Quality Management Solutions for global corporations.
For more information on ComplianceOnline or to browse through our training programs, please visit our website