Speaker Profile


Danielle DeLucy

Owner, ASA Training and 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 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.
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

Speaker:Danielle DeLucy
Time: 19th November 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : AQ-9055

Mon
19
Nov 2018

Developing an Effective CAPA Management and Root Cause Analysis System
Developing an Effective CAPA Management and Root Cause Analysis System

Speaker:Danielle DeLucy
Time: 20th May 2019 10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Model : PMAQ-9243

Mon
20
May 2019

Developing an Effective CAPA Management and Root Cause Analysis System
Developing an Effective CAPA Management and Root Cause Analysis System

Speaker:Danielle DeLucy
Time: 6th September 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : AQ-9054

Thu
06
Sep 2018

Effective SOP Development for Regulatory Compliance
Effective SOP Development for Regulatory Compliance

Speaker:Danielle DeLucy
Time: 12th November 2018 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : AQ-9053

Mon
12
Nov 2018

Efficient and Effective Batch Record Reviews to Improve your Process Capabilities
Efficient and Effective Batch Record Reviews to Improve your Process Capabilities

Speaker:Danielle DeLucy
Time: 3rd May 2019 10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Model : PMAQ-9242

Fri
03
May 2019

Handling OOS Test Results and Completing Robust Investigations
Handling OOS Test Results and Completing Robust Investigations

Speaker:Danielle DeLucy
Time: 4th July 2019 10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Model : FDAQ-9299

Thu
04
Jul 2019

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