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When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.
In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.
Learn moreRemember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.
Many organizations conduct quality audits because they are required to do so by their company or a regulatory agency. Others conduct the audits because they have been a good check for compliance to the regulatory standards. While all these reasons have varying degrees of validity, none of them articulate the best reason for having a robust quality audit program.
A good quality audit program should allow an organization to assess and periodically re-affirm the ability of its departments to provide conforming product consistently, reliably, and compliantly. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable quality culture.
When developing the quality audit, there are several requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical.
This accredited, 12-hour training event is designed to provide the participants with a working knowledge of quality audits. The why, when, who, how, and what of conducting a quality audit will be reviewed to ensure that your organization is capable of meeting all the regulatory expectations.
Can’t Make the LIVE Course dates?
You can register now for the on demand! Simply select the On Demand option when registering and we will automatically send you access to the recorded version for you to view for 30 days. On Demand will be available within 2 weeks after the live offering.
PLEASE NOTE:Since this training is highly interactive, you must have a webcam on your computer equipped with a microphone and speakers/headset in order to fully participate.
This overview training has been designed for the needs of professionals in all areas of the life sciences including pharmaceutical and biopharma science, medical devices, analytical chemistry, clinical and pre-clinical, specialty chemical and even food science.
Those involved within QA /QC, Laboratory, Production, Regulations and Supply Chain will benefit greatly by attending this training.
Danielle DeLucy, MS
Owner, ASA Training & Quality Consulting LLC
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 23 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.