Conducting a Successful Supplier Audit
Danielle DeLucy, MS, is the 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 to establish more robust quality systems so that the company can succeed.
When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier is capable of meeting all of your expectations. This is the first step in selecting the correct supplier to meet your outsourcing needs.
- Why audit your supplier?
- Who will audit your supplier?
- When will you audit your supplier?
- What will you audit?
- How will you conduct the audit
- How to prepare a pre-audit questionnaire
- Areas to be audited and using checklists
- How to conduct effective closeout meetings
- The advantages and disadvantages of using numerical audit scores
- Issuing observation reports and recommendations to your management and to your potential suppliers
Course Level - Intermediate
Who Should Attend
- QA staff and management
- Supply Chain Representatives
- Regulatory Affairs staff and management
- Compliance Auditors
Why Should You Attend
Many organizations conduct supplier audits because they are required to do so by their customers or a regulatory agency. Others conduct the audits because they have been led to believe that it's a good tool for comparing various suppliers against an arbitrary list of criteria. While all of these reasons have varying degrees of validity, none of them articulate the best reason for having a robust supplier audit program. A good supplier audit program should allow an organization to assess and periodically re-affirm the ability of key suppliers to provide conforming products consistently, reliably, and on time. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable supply chain.