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Danielle DeLucy
Principal/Owner, ASA Training & Quality Consulting, LLCDanielle 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.
Recorded-webinar by: Danielle DeLucy
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Essential Tips For Effective Batch Record Reviews: Enhancing Process Capabilities with High-Stakes Importance
In today’s fast-paced environment, everything needs to be done right the first time. This is especially important when releasing pharmaceutical and biological products to the market.
Batch Record Review is a critical part of your operations. It's not just an important part of your quality control - it's a mandatory global 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 there's nothing to worry about. But if your batch control documents are difficult to read, sloppy, or worse – non-existent – your company could be in big trouble. From sanctions to recalls, the cost of sloppy work can be astronomical.
Since a strong batch record review system is essential for the manufacture of pharmaceuticals, biologics, medical devices, etc., why leave anything up to chance? Fortunately, there are simple steps you can take to ensure that you're meeting regulatory requirements and producing quality products.
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Implementing An Effective Change Control Quality System Successfully
A good robust change control system is imperative for ensuring that the organization’s facilities, equipment, procedures, processes and systems remain in a validated and compliant state.
A change can be an addition/deletion/modification to an organization's facility, utilities, processes, materials, products, procedures, or equipment (including IT systems), which may impact product quality or regulatory obligations.
The purpose of a regulatory inspection is to ensure that your facility is in compliance with FDA rules and regulations. Investigators want to know that product was manufactured appropriately and that the current Good Manufacturing Practices are up to FDA standard. An inspection can be very intimidating to all involved, but it is vital if you want an inspection that results in a satisfactory report.
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 also be discussed.
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Steam Sterilization Microbiology and Autoclave Performance Qualification
Analyze the steam sterilization mechanism as it relates to endospores and bacterial cells.
Fundamental understanding of steam sterilization microbiology is essential for successful autoclave performance qualification.
In this session, expert speaker Danielle DeLucy will describe the steam sterilization mechanism as it relates to endospores and bacterial cells. She will define key terminologies and processes and provide an understanding of fundamentals crucial in creating a successful autoclave sterilization process.
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