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Speaker Profile
DANIELLE DELUCY

Danielle DeLucy, MS, is an 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 to establish more robust quality systems so that the company can succeed.


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Showing 1 to 14 of 14 (1 Pages)
$200.00
Effective Batch Record Review

 Danielle Delucy
 Recorded Webinar
 60 Minutes
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, there must be written procedures for a batch record review process that demonstrate compliance.A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production an..

$200.00
How to Write and Manage a Change Control System

 Danielle Delucy
 Recorded Webinar
 60 Minutes
How to Write and Manage a Change Control System

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 co-ordination of all change activities will also be discussed.Areas CoveredIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate how..

$200.00
Implementing a Change Control Quality System Successfully

 Danielle Delucy
 Recorded Webinar
 60 Minutes
Implementing a Change Control Quality System Successfully

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 coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..

$200.00
Achieving Compliance with Proper CAPA Systems

 Danielle Delucy
 Recorded Webinar
 60 Minutes
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 and ensure they stay on track.  Learning Objectives Discuss what to do when problems occurOutline the requirements of the CAPA process and proc..

$200.00
Answering and Replying to an FDA 483

 Danielle Delucy
 Recorded Webinar
 60 Minutes
 Download Catalog
Answering and Replying to an FDA 483

A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or..

$200.00
Batch Record Review and Product Release

 Danielle Delucy
 Recorded Webinar
 60 Minutes
 Download Catalog
Batch Record Review and Product Release

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
Best Practices For Investigating Deviations

 Danielle Delucy
 Recorded Webinar
 60 Minutes
 Download Catalog
Best Practices For Investigating Deviations

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
Capturing Justifications in Change Control, Risk Assessment, Validations, and Investigations

 Danielle Delucy
 Recorded Webinar
 75 Minutes
 Download Catalog
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 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
Complaint Handling and Adverse Event Reporting, CAPA, Recalls, and Product Life Cycle Management

 Danielle Delucy
 Recorded Webinar
 60 Minutes
 Download Catalog
Complaint Handling and Adverse Event Reporting, CAPA, Recalls, and Product Life Cycle Management

Complaint handling is essentially the beginning of the process if not one crucial aspect of the process of collecting data concerning the product that is in the marketplace. It is your first “tip-off” that something might not be going as intended. Complaints are ignored at your peril and ignoring them results in a significant risk to the organization and to the patients that use your products.Complaint hand..

$200.00
Developing an Effective CAPA Management and Root Cause Analysis System

 Danielle Delucy
 Recorded Webinar
 60 Minutes
 Download Catalog
Developing an Effective CAPA Management and Root Cause Analysis System

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 others in the organization, to employ critical thinking. The process must provide a common model and language within the organization, which..

$200.00
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

 Danielle Delucy
 Recorded Webinar
 60 Minutes
 Download Catalog
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions

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. Having inadequate investigations could potentially cause some severe issues for the company and may sometimes result in warning letters, consent decrees or recalls.Learning ObjectivesDiscuss what to do when problems o..

$200.00
Quality System Management Effectiveness

 Danielle Delucy
 Recorded Webinar
 90 Minutes
 Download Catalog
Quality System Management Effectiveness

Quality management training will cover principles of QMS that will help your organization implement a QMS that is repeatable and efficient. A good QMS consists of standards and guidelines relating to their everyday business practices including but not limited to policies/procedures (or a Quality Manual), SOPs, and Work Instructions.It’s the common, centralized culture of quality that many people struggle wi..

$200.00
Risk Based Environmental Monitoring

 Danielle Delucy
 Recorded Webinar
 60 Minutes
 Download Catalog
Risk Based Environmental Monitoring

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
Step by Step Process for Successful Sterility Failure Investigations

 Danielle Delucy
 Recorded Webinar
 90 Minutes
 Download Catalog
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, the environment, and the like. As such, there is no one size fits all investigation.  Microbiological testing covers a wide range of products, processes, an..

Showing 1 to 14 of 14 (1 Pages)