Successful Supplier Audits
Learn how supplier audits verify compliance, uncover nonconformances across key processes and support a supplier quality management function that benefits both companies.
Speaker
Danielle DeLucy
Pharmaceutical quality consultant · ASA Training and Consulting, LLC · MS
Overview
Supplier audits document the relationship between companies and verify that a supplier's products and processes comply with what was agreed during selection. This 60-minute supplier audit training explains how to run them so they add value.
An audit can uncover nonconformances in manufacturing, engineering change, invoicing, quality and shipment processes. You'll see how audits support an overall quality system, including document and records control, operations control, management review, nonconforming product control, calibration control and contract review.
The session also covers supplier measurement, proactive and reactive risk mitigation, and building a supplier quality management function that shares improvements for common gain.
Why attend: Many companies need to confirm supplier compliance but struggle to free up engineers for field audits without delaying current projects. Others want better return on auditing (ROA) or an audit process tied to internal goals and supplier commitments. This session suits site quality operations managers, QA and QC lab staff, plant managers and supervisors, manufacturing managers and regulatory affairs managers who want a consistent, mutually beneficial supplier audit program.
What’s covered
- What supplier audits are and why companies use them
- Finding nonconformances in manufacturing, engineering change, invoicing, quality and shipment processes
- Supplier audits within an overall quality system
- Document control, records control and operations control
- Management review and customer satisfaction
- Nonconforming product control, calibration control and contract review
- Supplier measurement and proactive and reactive risk mitigation
- Sharing information and product improvements between suppliers and companies
- Building a supplier quality management function and strong supplier relationships
- Improving return on auditing (ROA) with an integrated audit process
Who should attend
What you get
About the speaker
Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.
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