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.
Upcoming Webinar
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 are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
Live Session Wednesday, 29 May 2019, 10:00 AM PDT | 01:00 PM EDT, Duration: 60 Minutes

Recorded Webinar
Developing an Effective CAPA Management and Root Cause Analysis System
This 90-minute webinar will include discussions on 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 and ensure they stay on track.
Recorded Session Get life time access for one participant with download option!

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 prepare your laboratory for FDA.
Recorded Session Get life time access for one participant with download option!

Efficient and Effective Batch Record Reviews to Improve your Process Capabilities
Batch Record Review is a critical part of your operations. This practice is both a vital component to your quality efforts, and a global regulatory requirement. Your firm’s production efforts must be carefully documented. Standard Operating Procedures (SOPs), process controls, and deviations all fall under the purview of batch control. If your efforts are clear, concise, and repeatable, then you have nothing to fear. If your batch control documents are difficult to read, sloppy or worse – non-existent – then look forward to a litany of sanctions, recalls, and costly delays.
Recorded Session Get life time access for one participant with download option!

Step-by-Step Process for Successful Sterility Failure Investigations
There is no one size fits all investigation for microbial contamination. Microbiological testing covers a wide range of products, processes and environments, therefore representative samples from each of these categories forms the basis of what gets investigated. The role of QC microbiology in the identification and investigation of various results from manufacturing areas and finished product testing is extremely important. When the need for an investigation arises, it is common for a cross functional team to convene involving all levels of management from various departments - quality control chemistry and microbiology, manufacturing, quality assurance, and, facilities and engineering.
Recorded Session Get life time access for one participant with download option!

Developing an Effective CAPA Management and Root Cause Analysis System
This 90-minute webinar will include discussions on 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 and ensure they stay on track.
Recorded Session Get life time access for one participant with download option!

Understanding Proper Aseptic Technique and Cleanroom Behavior
This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why cleanrooms are designed the way they are.
Recorded Session Get life time access for one participant with download option!

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 final implementation of a change control quality system. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.
Recorded Session Get life time access for one participant with download option!

Effective SOP Development for Regulatory Compliance
Attend this webinar by expert speaker Danielle DeLucy, MS, to know how you can write, organize and maintain SOPs and also train your staff/personnel effectively to ensure reproducible and easy-to-follow compliance.
Recorded Session Get life time access for one participant with download option!

How to Conduct an Effective Annual Product Quality Review
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe. It will also discuss the comparative evaluation about similarities and differences of requirements associated with the manufacturing of the drug product in different countries. It is also necessary to know that the regulatory requirements of different countries are different and hence this will further guarantee the quality of the pharmaceutical product.
Recorded Session Get life time access for one participant with download option!

Good Documentation Practices
This webinar will cover the basics of what good documentation practices include, along with examples of practices not acceptable to auditors. This webinar will help attendees review their own procedures and what should be included in applicable training sessions for new employees along with refresher training for those who are more experienced.
Recorded Session Get life time access for one participant with download option!

Best Practices for Deviation Investigations
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using documents, interviews, and objective evidence to arrive at a root cause and a corrective and preventative action plan.Learn how to identify and classify deviations for easier management and investigation.
Recorded Session Get life time access for one participant with download option!

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 final implementation of a change control quality system. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.
Recorded Session Get life time access for one participant with download option!

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