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.
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Data Integrity for the Laboratory and Beyond
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid... -
2-Day Virtual Seminar on FDA Inspection Essentials in 2022
Upon completion of this session, you will learn the proper way to set up for a Regulatory Inspection, ensuring the inspection flows smoothly throughout the duration, and the proper way to speak to inspectors while they are performing the... -
4-Hour Virtual Seminar on Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
Aseptic techniques are used to create compounded sterile products. In Microbiological term; Aseptic technique refers to prevention of microorganism contamination. This activity is most important for successfully manufacturing safe and sterile therapeutics. Continuous cleaning, meticulous processing, sterile apparel and... -
10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love
For a number of years now there has been an increasingly number of CGMP violations involving data integrity during CGMP inspections as observed by the FDA. One of the most important responsibilities of the industry is to ensure data... -
How to conduct Annual Product Reviews to achieve GMP Compliance
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 in the specifications of the product or any change... -
Aseptic Process Simulations – A Comprehensive Guide for Proper Execution
Aseptic processing, the technique used to ensure sterile drugs are packaged in sterile containers, is one of the most important steps in biopharmaceutical manufacturing, because of the risk that contamination poses to patient safety. An Aseptic Process Simulation is... -
Sunshine Act Reporting – Clarification for Clinical Research
This webinar will summarize the Sunshine Act or Open Payments Program requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators. The Sunshine Act or Open Payments Program requires manufacturers of... -
3-Hour Virtual Seminar on Handling OOS Test Results and Completing Robust Investigations
This seminar 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 will be used to help the attendees clearly understand the steps... -
Effective Standard Operating Procedure (SOPs) Development
The FDA and other world health authorities require industries to submit Standard Operating Procedures (SOPs). However, at present, there exists no guide on how to develop or manage SOP creation, or regarding the SOP quality system. Because of that,... -
4-Hour Virtual Seminar on 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 procedures for a batch record review process that demonstrate compliance. A strong... -
How to Conduct Successful Supplier Audits
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations. When... -
3-Hour Virtual Seminar on Successful Deviation Investigations
This seminar will help attendees with the fundamentals and best practices for investigating deviations. It will focus on using facts and objective evidence to arrive at root cause and CAPA. To accomplish successful deviation investigations this course will focus... -
Successful Change Control Management
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will... -
Good Documentation Practices
“Good Documentation Practices” is a “current” industry practice that is reviewed and cited by federal regulators when audited. Pharmaceutical/Biological document are legal documents that are controlled by all regulatory agencies. The person or persons responsible for filling out these... -
Understanding Aseptic Technique and Cleanroom Behavior – Avoiding Human Error
Compounded sterile products are made utilizing aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. Most importantly, this activity is critical for the successful manufacture of safe and sterile therapeutics. The procedure involves... -
Biosafety and Blood borne Pathogen Safety in the Lab
The Centers for Disease Control and Prevention (CDC) has created regulations and guidelines that are recommended while working with biological materials, specifically, with blood borne pathogens. Join this webinar as we review these guidelines. Join in this webinar as... -
Conducting Successful Quality Audits
When developing the quality audit, there are a number of requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. This webinar is designed to provide the participants... -
Achieving Compliance with Proper CAPA Systems
This webinar will include discussions proper CAPA system maintenance, root cause analysis, documentation of the Corrective and Preventative Actions and developing a robust CAPA plan. It will give tips on how to develop CAPAs pertaining to longer term projects... -
Effective Batch Record Review
Most regulatory agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, in order to demonstrate compliance, there must be written procedures for a batch record review process.... -
Process Validation LifeCycle
This training is intended to help you better understand and get familiar with best practices for Process Validation applicable for the highly regulated biological / pharmaceutical industry. This course is further intended to discuss the life cycle of the... -
Laboratory Controls – Anticipate the Systems Based FDA Inspection
This training on laboratory controls will focus on all of the systems that are in a laboratory that will be audited by an FDA inspector in a typical systems-based inspection. After this webinar, you will fully understand how to... -
Proper Root Cause Analysis
In many companies, deviation/non-conformance investigations are often criticized for the lack of a robust root cause analysis. Proper root cause can help a company in many ways. Root cause analysis helps identify what, how and why something happened, thus... -
Step-by-Step Process for Successful Sterility Failure Investigations
There are many different types of microbial contamination that can occur in pharmaceutical manufacturing. Some of the sources include: water, raw materials, excipients, in-process materials and samples, the manufacturing process, the product itself, and the general manufacturing environment. As... -
Guideline to Aseptic Technique and Clean Room Behavior
Aseptic technique, in sterile compounding, contributes in preventing microbiological contamination. Aseptic technique is being used to provide safety, efficacy and sterility to the products that are sterile in nature, especially when it comes to various patient injections. This course... -
Successful Deviation Investigations
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that... -
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
When there is a need to make some change to an environment and/or resolve a problem, we must think about a project that could implement the necessary change and address the problem. But we can’t just run our project... -
Critical Elements Of Quality Risk Management Relating to FDA Compliance
This training program will discuss risk management and outline the requirements for applying risk management to the quality system. It will also discuss how to conduct and implement risk management practices at your firm and review communication techniques to... -
Steam Sterilization Microbiology and Autoclave Performance Qualification
Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this session, expert speaker Danielle DeLucy will describe the steam sterilization mechanism as it relates to endospores and bacterial cells. The process and key terminology... -
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 to manage properly. In this webinar, you will hear about... -
Sale!
How to Properly Investigate OOS Results
The lack of or Inadequate procedures for handling out of specification (OOS) situations and failure investigations are amongst the most frequently found deviations in FDA warning letters. Most companies have procedures but either they are not adequate or are... -
Robust CAPA and Proper Root Cause Analysis
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 CAPA process requires training internal investigators, who can also coach... -
Sale!
How to Conduct Successful Supplier Audits
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations. When... -
Sale!
Successfully Investigating Deviations
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that... -
Sale!
GMP Data Integrity – Implementation and Management
In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics... -
Sale!
Effective Standard Operating Procedure (SOPs) Development for Regulatory Compliance
The FDA and other world health authorities require industries to submit Standard Operating Procedures (SOPs). However, at present, there exists no guide on how to develop or manage SOP creation, or regarding the SOP quality system. Because of that,... -
How to conduct Annual Product Reviews to achieve GMP Compliance
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 in the specifications of the product or any change... -
Sale!
Sunshine Act Reporting – Clarification for Clinical Research
This webinar will summarize the Sunshine Act or Open Payments Program requirements and provide practical solutions to most common situations that are prevalent and necessary between sponsors and investigators. The Sunshine Act or Open Payments Program requires manufacturers of... -
Successful Change Control Management
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will... -
Good Documentation Practices
“Good documentation practices” is a “current” industry practice that is reviewed and cited by federal regulators when audited. Pharmaceutical/Biological document are legal documents that are controlled by all regulatory agencies. The person or persons responsible for filling out these... -
Good Documentation Practices
“Good documentation practices” is a “current” industry practice that is reviewed and cited by federal regulators when audited. Pharmaceutical/Biological document are legal documents that are controlled by all regulatory agencies. The person or persons responsible for filling out these... -
Investigating Deviations – Best Practices
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that...
