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.
October 28 2021
01 : 00 PM EST
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. In this webinar, ..
November 18 2021
01 : 00 PM EST
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 ObjectivesIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrat..
December 10 2021
01 : 00 PM EST
Annual Product Quality Review (APR) is an evaluation conducted annually to determine if there are any possible changes in the process or manufacturing of the pharmaceutical product or any change in the specifications of the product or any change in the manufacturing process. It is designed to minimize product defects and also the risks associated with the manufacturing of the pharmaceutical product.Areas Co..
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..
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..
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..
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..
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..
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..
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..
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..
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..
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..
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..
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..