That 21 CFR Part 11 has a retention requirement for audit trail documentation?
The difference between getting your NDA or BLA approved by the FDA during the first cycle of product review and getting it approved much later may very well lie in how early and how effective you communicate with the agency. Full Story
Especially for Pharmaceuticals
Wouldn't it be great to launch a product globally? It certainly makes good business sense. But for medical device firms, it's an unreasonable goal because different countries require different submission formats.
By Matthew M. Lowe
Especially for Medical Devices
After the FDA shut down two tissue-recovery firms last year because of serious GTP violations, the agency issued a guidance reminding the industry to comply with the regulation.
Especially for Blood / Biologics
How to Solve the Top Five Training Management Challenges
A Warning Letter sent by the FDA in February to Medical Concepts Development, a Minnesota medical device company, listed eight CGMP violations. Two of the infractions were related to training management: failure to document employee training and failure to establish procedures for identifying training needs.
Why is training important to life science companies? The FDA states it clearly in the Quality System Regulation (QSR) Manual, which says: Quality is the responsibility of every employee any employee can generate a quality problem through ignorance of their job requirements or negligence.
It is imperative for life science employees to have the proper education and training for their jobs. Moreover, the FDA expects employers to provide continuous personnel training to make sure employees can effectively perform their jobs. Ongoing training is what makes training management critical; it is the area where many life science companies stumble. Here are five common challenges faced by life science companies and some possible solutions. Read more.
FDA Listens to Public Input on Electronic Submission
By Lane Hirning
The FDA wants to eventually move to an all-electronic regulatory submission environment. The question is, how?
Representatives of 26 companies and organizations presented their views and six others made public comments at the FDA's public hearing on the viability of a paperless regulatory submission process.
"Let me stress this is a listening exercise for FDA," said Dr. Janet Woodcock, deputy commissioner for operations of the Food and Drug Administration, at the meeting held on Dec. 18, 2006. The public hearing discussed feasibility issues pertaining to electronic pre-market submissions and issues related to the concept of an electronic platform for the exchange of clinical research information and other regulatory product information.
Over the last decade, the FDA has transformed some aspects of regulatory reporting from paper to electronic means, but the adoption has been voluntary. The FDA has also been collaborating with manufacturers, standard development organizations, and other government agencies to develop data standards and build databases for sharing certain clinical trial information. Read more.