Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans If a GLP inspector requests information retained in an archive, can a test facility respond by retrieving electronic records from a company’s global electronic archiving system (physically located in another country)? 1.53K viewsPharmaceutical 0 Votes 1 Ans Can containers, closures, and packaging materials be sampled for receipt examination in the warehouse? 1.35K viewsPharmaceutical 0 Votes 1 Ans Some products, such as transdermal patches, are made using manufacturing processes with higher in-process material reject rates than for other products and processes. Is this okay? 1.69K viewsPharmaceutical 0 Votes 1 Ans Do CGMPs require three successful process validation batches before a new active pharmaceutical ingredient (API) or a finished drug product is released for distribution? 1.64K viewsPharmaceutical 0 Votes 1 Ans Some in the pharmaceutical industry have expressed concern that the ICH E3 guidance, Structure and Content of Clinical Study Reports (ICH E3), is intended as a requirement (i.e., a template that must be followed). The fact that the ICH M4 guidance for the Common Technical Document (CTD) refers to specific structural elements described in ICH E3 (e.g., Clinical Study Report (CSR) section headings) may have contributed to this interpretation. Interpretation of ICH E3 as a rigid template. 1.63K viewsClinical Research 0 Votes 1 Ans Is informed consent required when treating/diagnosing a patient with an HUD? 1.55K viewsClinical Research 0 Votes 1 Ans What is the role of the quality unit in approving changes to master production instructions during clinical trials? What is the quality unit’s role in reviewing and approving the master production instructions in phase I and phase II? 1.74K viewsClinical Research 0 Votes 1 Ans Is an FDA food inspection the same as a food safety system’s audit? 1.66K viewsFood Safety 0 Votes 1 Ans What systems does FDA have in place to protect the U.S. food supply? 1.69K viewsFood Safety 0 Votes 1 Ans What is FDA doing to ensure the safety of products imported from Japan? 1.79K viewsFood Safety 0 Votes 1 Ans What specific tests is FDA using? 1.63K viewsFood Safety 0 Votes 1 Ans What does FDA look for when it tests food for radioactive contamination? 1.48K viewsFood Safety 0 Votes 1 Ans What are the standards FDA uses to determine the amounts of specific radioactive materials in foods and whether they may cause a safety concern? 1.40K viewsFood Safety 0 Votes 1 Ans A married couple works for the same company. Both apply for FML after birth of the baby. Are both granted? 1.69K viewsHuman Resources 0 Votes 1 Ans Could an employee who qualifies under AFLA, later qualify for the FMLA entitlement (i.e., state paid health insurance), when, and if, they meet the FMLA employment threshold? 1.29K viewsHuman Resources 0 Votes 1 Ans I have an employee who is often out of work for a recurring illness. I’m not sure that her condition qualifies her for FMLA leave. How do I make that determination? 1.58K viewsHuman Resources 0 Votes 1 Ans Am I violating a worker’s rights under the FMLA if I change his work shift while he is gone? 1.69K viewsHuman Resources 0 Votes 1 Ans If an employee’s FMLA leave starts before the employee is eligible but continues after the employee becomes eligible what portion of the leave, if any, is FMLA covered? 1.68K viewsHuman Resources 0 Votes 1 Ans What if an employee also needs light duty in addition to intermittent or reduced schedule leave, must an employer provide light duty? 1.74K viewsHuman Resources 0 Votes 1 Ans Is there any additional steps that should be taken for ATMs for casinos? 1.70K viewsBanking and Finance « Previous 1 2 … 281 282 283 284 Next » Question and answer is powered by anspress.net
