+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

PRINTER FRIENDLY

Implementation and Management of GMP Data Integrity - Webinar - Product Image

Implementation and Management of GMP Data Integrity - Webinar

  • ID: 4594560
  • Webinar
  • August 2018
  • Region: Global
  • 90 Minutes
  • Compliance Online
1 of 3
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
Note: Product cover images may vary from those shown
2 of 3
  • 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
Note: Product cover images may vary from those shown
3 of 3

Loading
LOADING...

4 of 3
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.
Note: Product cover images may vary from those shown
Adroll
adroll