Including vendor selection and management, stability, labeling, and documentation requirements will also be reviewed and explored.
The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.
Because the current Directive will be significantly altered and replaced by a Regulation which is legally binding on all Member States.
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 […]
Original software design for an intended use is only the first step, the next design step is thinking about how someone can make your software worthless.
The most effective techniques for extracting information from SMEs as well as those techniques that work best when observing procedures and activities to be documented.
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 […]
Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them.
Focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance.
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. […]