Implementation and Management of GMP Data Integrity

Event Information
Product Format
Prerecorded Event
Conference Date
Mon, Aug 28, 2017
60 minutes
Product Description

Regulatory Expectations for Implementing and Managing GMP Data Integrity

An increased focus on laboratory and computer system data integrity has been taking over regulatory inspections in the past few years. In fact, deviations in this area have led to major compliance and financial consequences for drug companies. Companies may feel that data integrity issues only result from employees committing deliberate fraud; however, some of these issues can arise from poor training, bad practices and a poor culture of quality.

Join this session, where expert speaker Danielle DeLucy, MS, will discuss about the regulatory expectations regarding data integrity. The session will help you review practices at your own site and identify gaps in your own practices.

Session Highlights

  • Regulatory expectations and requirements regarding data integrity
  • ALCOA acronym and regulatory expectations
  • Common issues with data integrity
  • Data integrity: Process flow mapping
  • Data integrity criteria
  • Data integrity warning letter citations

Who Should Attend

  • Lab managers
  • Regulatory personnel
  • Quality control analysts
  • QA professionals

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Danielle DeLucy

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...   More Info
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