Danielle DeLucy
Danielle DeLucy
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.
Live Webinar
By: Danielle DeLucy
Nov. 13, 2026
Batch Record Review and Product Release
Regulatory agencies expect firms to keep written procedures for production and process controls, known as batch records, and for the process used to review them. This 60-minute batch record review…
Industry: Medical Devices Duration: 60 Minutes Time: 12:00 PM PDT | 03:00 PM EDT
Recorded Session
By: Danielle DeLucy
Recorded Session
Sunshine Act Reporting - Clarification for Clinical Research
Sunshine Act reporting affects every sponsor that pays clinical investigators. The Open Payments Program requires makers of drugs, medical devices and biologics that take part in U.S. federal heal…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Successful Supplier Audits
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…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Intro to Proper Aseptic Technique and Clean room Behaviour
Aseptic technique is how sterile compounding prevents microbial contamination, protecting the sterility, safety and efficacy of products such as injections for patients. It relies on specialized e…
Industry: Pharmaceutical Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Implementing a Change Control Quality System Successfully
Change control is a key element of any quality management system. This 60-minute change control training covers the fundamental steps and processes, from the change proposal through assessment, ex…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
FDA Case Scenarios - Best Practices for Managing Inspection Situations
Even well-trained staff can face difficult situations once an FDA inspection begins. This 60-minute FDA inspection management webinar uses real-life examples to show how tricky requests and issues…
Industry: FDA Compliance Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Proper Execution of Annual Product Reviews
An Annual Product Quality Review (APR) is a yearly evaluation that checks whether there have been changes to a pharmaceutical product's specifications or manufacturing process. Its purpose is to r…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Developing an Effective CAPA Management and Root Cause Analysis System
Every organization needs to investigate problems well, find root causes and put workable corrective action in place on time. This 60-minute CAPA and root cause analysis training shows how to build…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Preparing And Investigating Oos/Oot Results In A Regulated Environment
Missing or inadequate procedures for out-of-specification (OOS) results and failure investigations are among the most common deviations cited in FDA warning letters. This OOS and OOT investigation…
Industry: Medical Devices Duration: 60 Minutes