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In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, f ...
On July 4th 2025 President Trump signed in the One Big Beautiful Bill Act into law. This legislation is sweeping legislation that impacts all aspects of the United States. However, there are major impacts coming to employers and payroll departments across the ...
In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to ...
This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data in ...
This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data in ...
The artificial intelligence technologies granted FDA marketing authorization and cleared by the agency so far are generally called “locked” algorithms that don’t continually adapt or learn every time the algorithm is used. However, the FDA is looking beyond th ...
Due to the growth of electronic records and electronic signatures in CGMP documentation, as well as computer-controlled manufacturing, and medical devices, the US FDA has issued a draft Guidance for Industry, outlining its expectations for increased data integ ...
Recovering wage overpayments can be a time-consuming and sometimes challenging process for professionals. State laws governing recovery of employer overpayment and adjustment of related taxes often vary from the federal rules and from state to state. Recovery ...
This webinar will cover the reporting requirements for Forms 1099-MISC and 1099-NEC with a focus on the details and proper preparation of the forms. It will also cover updates to the Forms and 2024/2025 and beyond electronic filing methods and requirements. Th ...
This webinar will discuss updates to Forms in the 1099 Series for 2024. It will discuss information return reporting requirements and filing methods including the IRIS (Information Return Intake System) portal, how to access it and use it to file information r ...