Facts – Until You Reach Your the New EU Medical Device Regulation

Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.

Effectively Dealing with Harassment and Its Relationship to Discrimination, Retaliation, and Hostile Work Environments

In any case of workplace harassment, an employer’s behavior must meet a certain standard in the eyes of the law. Just posting an anti-harassment policy, while a positive step, is insufficient to prove that an employer took workplace harassment seriously. Workplace harassment isn’t limited to sexual harassment and doesn’t preclude harassment between two people of […]

How the FDA interprets advertising and promotion in principle and in fact

If you go “off label” with advertising and promotion, FDA’s hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer […]

High degree of Assurance in its Manufacturing Process to Justify Commercial Distribution of the Product

Focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance.

It is important for organizations to validate their own Excel Spreadsheet Application

Organizations that validate their Excel spreadsheet applications stay compliant with FDA requirements,avoid 483’s and save two-thirds of the cost and time on validation. A critical requirement from the FDA is validation of electronic records. These electronic records have to be compliant with the set of FDA Code of Federal Regulations, the 21 CFR Part 11. […]