10 Sure-Fire Tips for Implementation and Management of GMP Data Integrity Any Investigator Would Love Recorded Webinar | Danielle DeLucy | From: Aug 25, 2021 - To: Dec 31, 2021 |
For several years now there has been an increasing 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 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 the 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:-
Who Should Attend:-
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.
