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 Webinars
Chronicles
By: Danielle DeLucy
Recorded Session
Preparing And Investigating Oos/Oot Results In A Regulated Environment
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart wil…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Developing an Effective CAPA Management and Root Cause Analysis System
In order to solve problems every organization must know how to conduct an effective investigation, identify root causes, and implement workable corrective action in a timely manner. An effective C…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Proper Execution of Annual Product Reviews
Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change i…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
FDA Case Scenarios - Best Practices for Managing Inspection Situations
Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard …
Industry: FDA Compliance Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Implementing a Change Control Quality System Successfully
This web training session is designed to help attendees understand the fundamental change control steps and processes. The expert trainer will focus on change proposals, assessments, execution and…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Intro to Proper Aseptic Technique and Clean room Behaviour
In sterile compounding, the aseptic technique contributes to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especia…
Industry: Pharmaceutical Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Successful Supplier Audits
Process of following the procedures and processes that are agreed on during a selection audit process. It identifies nonconformances in the manufacturing process, engineering change process, invoi…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Sunshine Act Reporting - Clarification for Clinical Research
This webinar will summarize the Sunshine Act or Open Payments Program requirements and provide practical solutions to the most common situations that are prevalent and necessary between sponsors a…
Industry: Medical Devices Duration: 60 Minutes
By: Danielle DeLucy
Recorded Session
Batch Record Review and Product Release
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedure…
Industry: Medical Devices Duration: 60 Minutes