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 17 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.
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities.
Deviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit.
This webinar will provide you with the regulatory framework and recommended guidelines, risk assessment for biological materials, structure of a robust biosafety program and on how to train employees exposed to biological hazards.
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
This webinar will review the regulatory requirements for investigating an OOS Investigation.
Speaker: Danielle DeLucy | View Anytime | Duration: 3 Hours | Price: $349.00 | View DetailsStandard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $199.00 | View DetailsDeviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $199.00 | View DetailsThis webinar will provide you with the regulatory framework and recommended guidelines, risk assessment for biological materials, structure of a robust biosafety program and on how to train employees exposed to biological hazards.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $199.00 | View DetailsMost Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: $595.00 | View DetailsMost Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: $595.00 | View DetailsThis webinar will review the regulatory requirements for investigating an OOS Investigation.
Speaker: Danielle DeLucy | View Anytime | Duration: 3 Hours | Price: $549.00 | View DetailsStandard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities.
Speaker: Danielle DeLucy | View Anytime | Duration: 90 Minutes | Price: $399.00 | View DetailsDeviation investigations are a very common topic to be reviewed during FDA investigations. Ensuring the firm has robust and complete write-ups of these situations is key to a successful audit.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $399.00 | View DetailsThis webinar will provide you with the regulatory framework and recommended guidelines, risk assessment for biological materials, structure of a robust biosafety program and on how to train employees exposed to biological hazards.
Speaker: Danielle DeLucy | View Anytime | Duration: 60 Minutes | Price: $399.00 | View DetailsMost Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: $945.00 | View DetailsMost Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records.
Speaker: Danielle DeLucy | View Anytime | Duration: 6 Hours | Price: $945.00 | View Details