Miss. Danielle Delucy

Area Of Expertise : Quality, Clinical Trials
25 Years Of Experience

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

28 results Found
Live Webinar

FDA Case Scenarios – Best Practices for Managing Inspection Situations

Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard to manage properly. In this webinar, you wil ...

  • Basic & Intermediate
  • 60 Mins
  • Aug 27, 2019
Live Webinar

How to Properly Investigate OOS Results

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly unde ...

  • Basic & Intermediate
  • 60 Mins
  • Sep 10, 2019
Recorded Webinar

Effective Standard Operating Procedure (SOPs) Development

Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP qualit ...

  • Basic & Intermediate
  • 60 Mins
Recorded Webinar

Effective Batch Record Review

In this webinar attendees will learn the fundamentals for reviewing batch records in a pharmaceuticals, biologics and medical devices environment. You will hear about the proper training that must be demonstrated before one is considered a ...

  • Intermediate
  • 60 Mins
Recorded Webinar

FDA Case Scenarios – Best Practices for Managing Inspection Situations

Companies can prepare and train their staffs effectively for prior inspection management, but once the audit begins, certain difficult situations, requests or issues may arise that may prove hard to manage properly. In this webinar, you wil ...

  • Intermediate
  • 60 Mins
Recorded Webinar

Investigating OOS results

This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly unde ...

  • Basic
  • 60 Mins
Recorded Webinar

Steam Sterilization Microbiology and Autoclave Performance Qualification

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 develop a successful autoclav ...

  • Basic & Advanced
  • 60 Mins
Recorded Webinar

FDA - Streamlining Your Internal Auditing Process

Internal audits are required by both the FDA and ISO 13485. This webinar will cover how to create a Risk-based, value-added internal auditing system for compliance with FDA and ISO 13485 internal auditing requirements. It will include how t ...

  • Intermediate
  • 60 Mins
Recorded Webinar

Achieving Success and Compliance in the Supply Chain

Supply chain is a system of organizations, people, activities, information, and resources involved in moving a product or service from supplier to customer. Supply chain activities involve the transformation of natural resources, raw materi ...

  • Basic & Intermediate & Advanced
  • 60 Mins
Recorded Webinar

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 justifica ...

  • Basic & Advanced
  • 90 Mins