Course “Tougher Import Rules for FDA Imports in 2019” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion. Description: FDA and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of import information and adherence […]
Why should you attend: Statistics is a useful decision making tool in the clinical research arena. When working in a field where a p-value can determine the next steps on development of a drug or procedure, it is imperative that decision makers understand the theory and application of statistics. Many statistical softwares are now available […]
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 […]
How do you know if you are pressing the right key, let alone performing the best test?
Risk management being a mandatory component of almost any activity in the medical device industry.
Metrology: QC Sampling Plans the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications.
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 […]