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Danielle DeLucy

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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

Recorded Session

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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  

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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  

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By: Danielle DeLucy

Recorded Session

Handling OOS Test Results and Completing Robust Investigations

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 wi…

Industry: Medical Devices   Duration: 60 Minutes  

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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  

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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  

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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