Implementation and Management of GMP Data Integrity.

Danielle DeLucy

Starting at

$249


Single registration

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Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Why Should You Attend:

In recent years, FDA has increasingly observed CGMP violations involving data integrity during CGMP inspections. This is troubling because ensuring data integrity is an important component of industry’s responsibility to ensure the safety, efficacy, and quality of drugs, biologics and medical devices. These data integrity-related CGMP violations have led to numerous regulatory actions, including warning letters, import alerts, and consent decrees.

In this webinar attendees will obtain an understanding of the regulatory expectations for Data Integrity. The information provided at the webinar will enable the attendees to review practices at their own site and identify gaps in their own practices.

Areas Covered in the Webinar:

  • Understand the current regulatory position on data integrity
  • Discover the criteria for data integrity
  • Recognize what needs to be addressed to ensure data integrity within a regulated GXP laboratory
  • Learn about approaches to improve data integrity in a laboratory environment
  • Part 11 compliance
  • FDA citations related to data integrity issues

Who Will Benefit:

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

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.




Get in touch

(315) 632-0735,
(315) 750-4379