Did you know that your career can be ruined, or you can even do jail time, in a product recall?
It has happened. Read here. And here. All FDA and DOJ have to show is that you ‘should have known’ about problems with your product. “I didn’t know” is NOT a defense!
That low standard means that companies under recall want to pay and settle quickly. Guess what? That means you can be thrown under the bus. It means your career can be destroyed in a flash. Continue reading
This Webinar by a team of seasoned GXP validation and SharePoint experts will introduce innovative best practice risk-based strategies, important processes and new exciting tools to help qualify enterprise Microsoft SharePoint deployments as well as validate mission critical applications such as clinical and investigator portals and document management in FDA regulated environments. Continue reading
Join us and learn from former FDA Chief Counsel Sheldon Bradshaw about FDA’s greater enforcement efforts and warning letter changes: setting post inspection deadlines, speeding up warning letter process, working more closely with regulatory partners, implementing warning letter close out process, and much more. Continue reading
Did you know that you must use FDA-defined terms where they exist – it’s best for you consider them “sacred.” In his 8th appearance in this highly praised webinar, discover a potential table of contents for your quality agreement, why you must use FDA defined terms where they exist. Learn the obligations for all stakeholders under a quality agreement, how to develop your quality agreement, and much much more. Continue reading
The FDA’s approach to enforcing product safety and efficacy is evolving when it comes to CMOs and CROs. FDA is increasingly holding both sponsors and contract organizations responsible for a product’s safety and effectiveness. Whether in clinical trials or in the post-market stage, patient safety is the #1 driver for FDA enforcement. So how do you ensure your CMO or CRO can pass an inspection centered around your product? And will the agency only inspect the contracted manufacturer or trial monitor … or are there reasons why the inspector will visit you first? Continue reading
One of our most praised presentations, this Webinar by renowned eCTD expert Antoinette Azevedo will provide an overview of best practices to enable a sponsor to prepare a compliant eCTD for regulatory authority review. So you can avoid a costly Refuse-to-File (RTF) by FDA.
Negotiations are underway between FDA and industry on PDUFA V reauthorization. These negotiations will result in legislation submitted to Congress in January 2012. PDUFA must be reauthorized by October 1, 2012 to enable CDER and CBER to collect user fees and perform review of INDs, DMFs, NDAs, ANDAs and BLAs. PDUFA V is expected to mandate eCTD format for all submissions to CDER and CBER except for single-patient compassionate-use INDs. Continue reading
Did you know that 5 of the top 7 FDA risk enforcement priorities involve your senior management team?
Learn how your senior management team can management FDA compliance effectively with just 48 hours per year. Discover 14 typical FDA auditor questions regarding quality systems management, top 7 FDA risk enforcement priorities. Learn six do’s and seven don’ts on effective quality management oversight. Continue reading