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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.


Product Compare (0)
$179.00
Effective Batch Record Review

 Danielle Delucy
 May 26 2022
 01 : 00 PM EST    
 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 a..

$179.00
Understanding Aseptic Technique and Cleanroom Behavior

 Danielle Delucy
 June 14 2022
 01 : 00 PM EST    
 60 Minutes
Understanding Aseptic Technique and Cleanroom Behavior

Compounding sterile products are made utilizing the aseptic technique. Aseptic technique is a microbiological term referring to the prevention of microorganism contamination. The procedure involves the use of specialized equipment, sterile apparel, meticulous processing, and continuous cleaning.In sterile compounding, the aseptic technique is contributing to the prevention of microbiological contamination. ..

$179.00
Best Practices for Deviation Training

 Danielle Delucy
 July 12 2022
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Best Practices for Deviation Training

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 ..

$179.00
Conducting a Successful Supplier Audit

 Danielle Delucy
 August 16 2022
 01 : 00 PM EST    
 60 Minutes
 Download Catalog
Conducting a Successful Supplier Audit

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..

Showing 1 to 15 of 17 (2 Pages)
$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
How to Write and Manage a Change Control System

 Danielle Delucy
 Recorded Webinar
 60 Minutes
 Download Catalog
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 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 contr..

$200.00
Implementation and Management of GMP Data Integrity

 Danielle Delucy
 Recorded Webinar
 60 Minutes
 Download Catalog
Implementation and Management of GMP Data Integrity

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 of both. To assure the quality of raw materials, in-process materials, and finished goods, laboratory data integrity is assuming greater importan..

$200.00
Proper Root Cause Analysis

 Danielle Delucy
 Recorded Webinar
 60 Minutes
 Download Catalog
Proper Root Cause Analysis

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
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..

Showing 1 to 15 of 17 (2 Pages)