The FDA’s Focus on Clinical Data Integrity Throughout Product ...
Will your clinical data withstand FDA and Department of Justice (DOJ) scrutiny of your drug development program, from preclinical development through clinical trials and ultimately to market …
Data Integrity in the EU: Requirements for Quality Management Systems
You’ll understand all the requirements with Data Integrity in the EU: Requirements for Quality Management Systems. This report details the ins and outs of all three documents and explains how …
Thai API Facility Hit With Warning Over Data Integrity - FDAnews
The FDA has warned a French drugmaker for data integrity issues related to the production of active pharmaceutical ingredients at its Thailand manufacturing plant. According to the Feb. 27 warning …
FDA Scrutinizing Data Integrity Issues in Applications: Training ...
The FDA is implementing specialized training courses instructing agency inspectors on how to identify data integrity and fraud issues that have surfaced within the last two years, according to Edwin …
Data Integrity in the COVID-19 Era and Beyond - fdanews.com
Data integrity expert Sue Schniepp will lead conversations and panels around data in the time of COVID-19. She and a group of experts will share tips and examples around altering operations, …
FDA to Sponsors: Applications Linked to Semler Research No Longer ...
Sponsors with pending NDAs and ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said.
Auditing for Quality Manufacturing: Five Areas of Risk for Drug and ...
This management report points to five important areas of focus — data integrity, quality culture, aging facilities, investigating manufacturing problems and risk management — in auditing to ensure quality.
Spreadsheet Validation: Tools and Techniques to Make Data in Excel ...
With this updated Spreadsheet Validation management report, you’ll discover how to move a spreadsheet toward validation with the FDA, determining the best ways to conform with data integrity …
Using IT to Improve Data Integrity – Webinar Recording/Transcript
Is IT a fully vested member of your data integrity team? The success of your next inspection could depend on it. But many firms — yours among them, perhaps — haven’t fully brought the IT folks onto …
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Wide variety of topics to help you stay in compliance with the FDA. Instant, on-demand, unlimited access to all 700+ archived webinars and 40 new ones we’re working on. One automatic registration …