Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans A firm has multiple media fill failures. They conducted their media fills using TSB (tryptic soy broth) prepared by filtration through a 0.2 micron sterilizing filter. Investigation did not show any obvious causes. What could be the source of contamination? 1.26K viewsPharmaceutical 0 Votes 1 Ans What is the acceptable media fill frequency in relation to the number of shifts? Normally, media fills should be repeated twice per shift per line per year. Is the same frequency expected of a process conducted in an isolator? 1.28K viewsPharmaceutical 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lifecycle risk management efforts to ensure microbial control? 934 viewsPharmaceutical 0 Votes 1 Ans FDA withdrew its draft guidance for industry on Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment. What were the Agency’s major concerns with this guidance? 1.20K viewsPharmaceutical 0 Votes 1 Ans Why is FDA concerned about proper sampling of powder blends? 886 viewsPharmaceutical 0 Votes 1 Ans What are some recommended innovative approaches to ensuring adequacy of mixing of powder blends? 1.30K viewsPharmaceutical 0 Votes 1 Ans What are the Agency’s recommendations regarding in-process stratified sampling of finished dosage units? 1.17K viewsPharmaceutical 0 Votes 1 Ans My medical condition limits me to a 40 hour workweek but my employer has assigned me to work eight hours of overtime in a week. Can I take FMLA leave for the overtime? 1.21K viewsHuman Resources 0 Votes 1 Ans Does the ADA require that an applicant or employee with a disability be qualified for the position? 1.00K viewsHuman Resources 0 Votes 1 Ans Does an employer have to give preference to an applicant with a disability over other applicants? 1.22K viewsHuman Resources 0 Votes 1 Ans What limitations does the ADA impose on medical examinations and inquiries about disability? 1.18K viewsHuman Resources 0 Votes 1 Ans When can an employer ask an applicant to “self-identify” as having a disability? 1.33K viewsHuman Resources 0 Votes 1 Ans Does the ADA require employers to develop written job descriptions? 1.11K viewsHuman Resources 0 Votes 1 Ans What are some of the accommodations applicants and employees may need? 1.29K viewsHuman Resources 0 Votes 1 Ans Does the ADA override federal and state health and safety laws? 1.12K viewsHuman Resources 0 Votes 1 Ans How does the ADA affect workers’ compensation programs? 1.29K viewsHuman Resources 0 Votes 1 Ans Who is covered by the FLSA? Are employees of small businesses covered? 1.05K viewsHuman Resources 0 Votes 1 Ans Who is entitled to the minimum wage and overtime pay under the FLSA? 1.19K viewsHuman Resources 0 Votes 1 Ans Will newly overtime-eligible employees have to record their hours on a daily basis or “punch a time clock”? 1.28K viewsHuman Resources 0 Votes 1 Ans Is there an exemption for non-profit organizations from either the FLSA or the Department’s overtime regulations governing white collar workers? 1.18K viewsHuman Resources « Previous 1 2 … 279 280 281 282 283 284 Next » Question and answer is powered by anspress.net