10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love

For a number of years now there has been an increasingly number of CGMP violations involving data integrity during CGMP inspections as observed by the FDA. One of the most important responsibilities of the industry is to ensure data integrity is implemented. Data Integrity verification ensures the safety, efficacy, and the quality of drugs as per cGMP standards for biologics and medical devices. These CGMP violations have generated serious concern have led to numerous regulatory actions which have included warning letters, 483 observations, import alerts, and consent decrees. All of our webinar attendees will achieve a comprehensive understanding of FDA’s regulatory expectations for Data Integrity. Attendees will obtain the know-how and the confidence to review practices at their own site and identify gaps in their own practices.

Areas Covered in the Session :

  • Comprehend the current regulatory position on data integrity
  • Ascertain 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
  • 21 CFR Part 11 compliance
  • FDA citations related to data integrity issues
Who Should Attend:

  • Site Quality Operations Managers
  • Quality Assurance personnel
  • Plant Managers and Supervisors
  • Manufacturing Superintendents and Managers
  • Regulatory Affairs Managers

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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 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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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.