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Danielle DeLucy

Danielle DeLucy, MS, is Keynote speaker at Compliance Key, Inc. She is 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.

 Webinar Id: LSHCDD0001
10:00 AM PT | 01:00 PM ET
 01/26/2018
 Duration 60 mins

How to properly investigate OOS/OOT 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 understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.


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                $179
       Single Attendee
(Only for one Participant)
          $363
Multiple Attendee
( 2 - 5 Participants)
          $726
Corporate Attendee
( 6 - 10 Participants)
                   $237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCDD006
10:00 AM PT | 01:00 PM ET
 02/09/2018
 Duration 60 mins

Understanding Aseptic Technique and Cleanroom Behavior

Compounding sterile products are made utilizing 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.


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                $179
       Single Attendee
(Only for one Participant)
          $363
Multiple Attendee
( 2 - 5 Participants)
          $726
Corporate Attendee
( 6 - 10 Participants)
                   $237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCDD007
10:00 AM PT | 01:00 PM ET
 03/19/2018
 Duration 60 mins

FDA's Expectations from Supplier Management for GMP: Quality Agreements and More.

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 of supplier audits. The why, ........


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                $179
       Single Attendee
(Only for one Participant)
          $363
Multiple Attendee
( 2 - 5 Participants)
          $726
Corporate Attendee
( 6 - 10 Participants)
                   $237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCDD005
10:00 AM PT | 01:00 PM ET
 04/05/2018
 Duration 60 mins

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 materials, and components into a finished product that is delivered to the end customer.


View Details

                $179
       Single Attendee
(Only for one Participant)
          $363
Multiple Attendee
( 2 - 5 Participants)
          $726
Corporate Attendee
( 6 - 10 Participants)
                   $237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCDD009
10:00 AM PT | 01:00 PM ET
 05/24/2018
 Duration 60 mins

Applying Quality Risk Management

This webinar is intended to help you better understand and get familiar with best practices for FDA approval process for quality risk management (QRM) applicable for pharmaceutical industry. This webinar is further intended to discuss how risk management plans can be effectively integrated into a quality system (QS) in the pharmaceutical industry.


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                $179
       Single Attendee
(Only for one Participant)
          $363
Multiple Attendee
( 2 - 5 Participants)
          $726
Corporate Attendee
( 6 - 10 Participants)
                   $237
         Recorded
(6 months unlimited access)
 Webinar Id: LSHCSDD005
 View Anytime
 Duration 60 mins

Course Description - 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.

$237 Recorded (6 months unlimited access)

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 Webinar Id: LSHCSDD004
 View Anytime
 Duration 60 mins

Steam Sterilization Microbiology and Autoclave Performance Qualification

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 develop a successful autoclave sterilization process.

$237 Recorded (6 months unlimited access)

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 Webinar Id: LSHCDD001
 View Anytime
 Duration 60 mins

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 materials, and components into a finished product that is delivered to the end customer.

$237 Recorded (6 months unlimited access)

View Details

 Webinar Id: LSHCDD004
 View Anytime
 Duration 60 mins

Managing SOP Compliance per FDA Regulations

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 quality system.

$237 Recorded (6 months unlimited access)

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