21 CFR PART 11: Complete Manual for Compliance Success

FDA inspectors are ever increasing the number of inspections where they include Part 11 as a part of the scope or THE scope of the inspection. The trends and reports are showing that the FDA inspectors are focusing on electronic signatures and electronic records as more and more companies are implementing systems and technologies to […]

How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud

Course “How to be Efficient and Compliant with Part 11, Validation, and SaaS/Cloud” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT […]

200+ followers. WOWWWWWW…

Hello Everyone, Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community. we are so incredibly […]

Regulations in the US and EU Dealing with Combination Products

Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the […]

Orkambi Reduces Main Biomarker of CF, Vertex Says in Updated Results on Four Therapies

Orkambi (lumacaftor/ivacaftor) reduced levels of the main biomarker of the lung disease cystic fibrosis and improved the nutritional status of children with the condition, according to a Phase 3 clinical trial. The results were part of a recent update that Vertex Pharmaceuticals provided on Orkambi and three of its other CF therapies, Kalydeco (ivacaftor), tezacaftor (VX-661) and VX-371. Vertex […]

Drugstore stocks tumble as Amazon considers selling prescription drugs online

Shares of drugmakers dropped in midday trading Friday after CNBC reported Amazon is in the final stages of considering an entrance into selling drug prescriptions. Walgreens, Rite Aid and CVS Health stocks each slipped 4 percent or more as investors worried Amazon may disrupt the traditional distributors’ hold on the drug prescription market. Amazon will […]

Four years of the EU’s Cosmetics Product Regulation

It has been four years since the EU’s Cosmetics Product Regulation (Regulation EC No. 1223/2009), initiated in December 2009, became operational in July 2013. This regulation was considered path breaking when it was introduced because of its comprehensive nature as well as the extent of the shift it signaled from the legislation from which it […]