compliance news
Adverse Event Reporting for Dietary Supplements and OTC Drugs
by: davidross759, 1 pagesSince passage of the Dietary Supplement & Nonprescription Drug Consumer Protection Act in Dec. 2007, FDA requires reporting of serious adverse events for dietary supplements and OTC drugs
Analytical Test Methods Validation for GxP Laboratory Compliance DA,ICH and USP Requirements
by: davidross759, 2 pagesThis Validation training will address the regulatory requirements which apply at the various stages of development, and suggest proven strategies for compliant and phase-appropriate analytical method ...
Understanding and Implementing FDA's 21 CFR Part 11
by: davidross759, 2 pagesIn 1997 the US FDA issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures
Auditing Systems for 21CFR Part 11 Compliance
by: davidross759, 2 pagesLife sciences companies should regularly audit and assess computer systems for 21CFR Part 11 compliance, both their internal systems used in support of regulated GxP activities as well as systems ...
Creating Successful Device History Record and keep FDA happy in the process
by: davidross759, 2 pagesMany companies are confident that their record keeping for the firm's device history records is compliant to the Quality System regulation, yet when the FDA comes calling, FDA 483 DHR cites are ...
Designing a CAPA System that Meets and Exceeds Regulatory Requirements
by: davidross759, 2 pagesCAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a ...
Developing an Effective CAPA Strategy through Root Cause Analysis of Failures & Deviations
by: davidross759, 1 pagesInadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This webinar highlights FDA and EU regulations and how to ...
Developing and Using the Product Risk Management File/Report
by: davidross759, 2 pagesThe U.S. FDA has stated that the use of a medical device or pharmaceuticals entails some degree of risk. In fact, any medical procedure / intervention does. A manufacturer is responsible to identify ...
Device Changes and the 510(k)
by: davidross759, 2 pagesThe majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process
DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
by: davidross759, 2 pagesThis webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR
