DANIELLE DELUCY


Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations
: Danielle Delucy
Recorded Webinar

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 without proper justification. Justifying the project is a great mechanism to confirm that our project really addresses the need and paves the way for improvement. It helps us assure interested p.....

$200.00
Best Practices for Investigating Deviations
Best Practices for Investigating Deviations
: Danielle Delucy
Recorded Webinar

One of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations. The FDA uses the investigation reports and investigation trends to identify potential quality problems in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, a release of the sub-standard product, or product recall. Furthermore, costly and time-consum.....

$200.00
Steam Sterilization Microbiology and Autoclave Performance Qualification
Steam Sterilization Microbiology and Autoclave Performance Qualification
: Danielle Delucy
: 26 February 2019
: 01 : 00 PM EST
: 60 Minutes

Successful autoclave Performance Qualification starts with a fundamental understanding of steam sterilization microbiology. In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to developing a successful autoclave sterilization process.Sterilization proce.....

$179.00
Understanding Aseptic Technique and Cleanroom Behavior
Understanding Aseptic Technique and Cleanroom Behavior
: Danielle Delucy
Recorded Webinar

Aseptic technique, in sterile compounding, contributes to prevent 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 by expert speaker Danielle DeLucy will benefit those Aseptic operators, Aseptic sample handlers, personnel who work in a Biolo.....

$200.00
Proper Management of Regulatory Agency Inspections
Proper Management of Regulatory Agency Inspections
: Danielle Delucy
Recorded Webinar

The purpose of the Regulatory inspection is an activity that should demonstrate that your company is operating according to the proper CFR requirements and maintaining a state of compliance. The key to a successful audit is being able to communicate how your quality systems assure this state of control. Many times, the arrival of a Regulatory Investigator is a daunting experience for some. This webinar, you.....

$200.00
Batch Record Review and Product Release
Batch Record Review and Product Release
: Danielle Delucy
Recorded Webinar

This webinar will analyze each of these necessary elements of the batch record review process.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 batch record review system is essential in ord.....

$200.00
Conducting a Successful Supplier Audit
Conducting a Successful Supplier Audit
: Danielle Delucy
Recorded Webinar

When contemplating the use of a supplier you would normally have many requirements and expectations that must be met. These include technical, regulatory, quality, responsiveness, location, readiness, and those less defined but critical. One of the tools at your disposal to verify the supplier’s acceptability is to audit its operation. This webinar is designed to provide the participants a working knowledge.....

$200.00
Proper Root Cause Analysis
Proper Root Cause Analysis
: Danielle Delucy
Recorded Webinar

In many companies, deviation/non-conformance investigations are often criticized for the lack of a robust root cause analysis. The proper root cause can help a company in many ways. Root cause analysis helps identify what, how and why something happened, thus preventing recurrence. Root causes are underlying, are reasonably identifiable, can be controlled by management and allow for the generation of recomm.....

$200.00
How to Write and Manage a Change Control System
How to Write and Manage a Change Control System
: Danielle Delucy
Recorded Webinar

This webinar 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 coordination of all change activities will also be discussed.This course will provide attendees with the proper tools and information to build a robust change contro.....

$200.00
Risk Based Environmental Monitoring
Risk Based Environmental Monitoring
: Danielle Delucy
Recorded Webinar

Environmental Monitoring (EM) programs for pharmaceutical manufacturing are evolving to a risk-based approach. The use of sampling data for the identification and mitigation of risk becomes a critical element in this process. No longer is it enough to utilize data for reactive excursion reporting.This presentation will discuss how to establish a risk-based Environmental Monitoring Program. During this sessi.....

$200.00
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