Laboratory Controls: Anticipate the Systems Based FDA Inspection

Danielle DeLucy

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Course Description:

In this 90-minute accredited training, we will discuss laboratory controls.  It will focus on all of the systems that are in a laboratory that will be audited by an FDA inspector in a typical systems-based inspection. After this webinar, you will fully understand how to prepare your laboratory for FDA.

Many QA and QC personnel in the pharmaceutical industry are not familiar with the FDA systems-based inspection model. They are also not aware of the types of 483 observations that many FDA auditors make today. One of the most scrutinized areas during these inspections is the laboratory.  Because of this, it is important for lab personnel to know the techniques used the FDA inspections during these types if audits.   Knowing the systems, the FDA will look at is also key so that the lab can be properly prepared for the audit.

Who Should Attend:

Quality Control Personnel & Management

  • Manufacturing Personnel & Management
  • Senior Management
  • Regulatory Affairs Personnel & Management
  • Quality Assurance Personnel & Management 


Learning Objectives

  • List what makes up a Laboratory Control System
  • Discuss the responsibilities of the QC and QA personnel before and during the audit
  • Review the known high-risk areas to assess the level of compliance in your own laboratories
  • Improve and develop systems and procedures that will sustain a compliant laboratory operation

Course Outline :

Module 1: Defining the Systems Based Inspection

  • What are Lab Controls?
  • FDA inspection techniques
  • Why FDA switched to Systems based Inspections

Module 2: Preparing for a Laboratory Audit

  • Training of analysts in proper inspection behavior
  • Review of materials, equipment, tests and assays

 Module 3: Inspection Expectations and Results / Real Life citations

  • Responsibilities of QC / QA personnel during the audit
  • Addressing observations or findings
  • Real life citations


Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Danielle DeLucy, Pharmaceuticals, Biotechnology

Danielle DeLucy, MS, 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.

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