Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Can Leptospira species penetrate sterilizing-grade filters? If so, what should manufacturers keep in mind in their ongoing lifecycle risk management efforts to ensure microbial control? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans A married couple works for the same company. Both apply for FML after birth of the baby. Are both granted? 1.57K viewsHuman Resources 0 Votes 1 Ans Best method for designing a statistically sound sample plan for a pharmaceutical packaging process? – In the packaging process we are looking at several different attributes varying from critical defectives (AQL .065) to minor defectives (AQL 1.5). It is the goal to use one sample size that would statistically cover the different AQL range. If we have a batch size of 20,000 and a samples size of 315, would it be safe to say that the pass/reject level for AQL .065, 0-1 and 10-11 for an AQL 1.5. Is it statistically sound that we just pull one sample size? 1.31K viewsDrugsPharmaceutical 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. 1.60K viewsClinical Research 0 Votes 1 Ans What factors should an entity consider in evaluating whether the information that was the subject of the unauthorized acquisition, access, use, or disclosure qualifies as “unsecured protected health information”? 1.48K viewsHospital and Healthcare 0 Votes 1 Ans What were the primary findings of the Final Environmental Impact Statement (EIS) and Record of Decision (ROD)? 1.64K viewsFood Safety 0 Votes 1 Ans What do you think might be the biggest difference between the requirements of FDA’s device requirements and the EU’s MDR? 1.70K viewsMedical Device 0 Votes 1 Ans Do pharmaceutical manufacturers need to have written procedures for preventing growth of objectionable microorganisms in drug products not required to be sterile? What does objectionable mean anyway? 1.58K viewsDrugsPharmaceutical 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)? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the biggest challenges banks face in regulatory compliance 1.82K viewsBanking and Finance 0 Votes 1 Ans Are there any tools available to help my firm search the U.S. Treasury’s Office of Foreign Asset Control’s (OFAC) “Specially Designated Nationals and Blocked Persons” (SDN) list 1.65K viewsBanking and Finance 0 Votes 1 Ans Is informed consent required when treating/diagnosing a patient with an HUD? 1.59K viewsClinical Research 0 Votes 1 Ans Using paid time off (PTO) on PDL – Can you require an employee to use PTO (paid time off) while on pregnancy disability leave? 1.60K viewsHuman Resources 0 Votes 1 Ans Pregnancy Disability Leave (PDL): FMLA and CFRA – If I have an employee who is pregnant and they do not need to go on Pregnancy Disability Leave (PDL), then would they be just eligible for 12 weeks of leave under FMLA and CFRA running concurrently? 1.58K viewsHuman Resources 0 Votes 1 Ans Workers Compensation Claim and Physical ability assessment – What if the employee has Workers Compensation claim but he/she is still working. How does this work? Should we automatically put them on FMLA/ADA? The condition is carpal tunnel syndrome and should we have the doctor fill out a physical ability assessment? 1.71K viewsHuman Resources 0 Votes 1 Ans Do FMLA and CFRA run concurrently? 1.64K viewsHuman Resources 0 Votes 1 Ans ANDA OTC, prescription RLD NDA approved products – Can there be an ANDA OTC? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans Monographed product changes reporting -How do you report changes if you have a monographed product? 1.65K viewsDrugsPharmaceutical 0 Votes 1 Ans OTC drug registration-U.S. agent requirements and responsibilities – In order to register an OTC drug in the U.S. does the U.S. agent have to physically live or operate a business in the U.S. or can this agent live elsewhere? 1.52K viewsDrugsPharmaceutical 0 Votes 1 Ans Post approval change requirements of monographed products 1.57K viewsDrugsPharmaceutical « Previous 1 2 … 62 63 64 65 66 … 283 284 Next » Question and answer is powered by anspress.net
