Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans For drug products formulated with preservatives to inhibit microbial growth, is it necessary to test for preservatives as part of batch release and stability testing? 1.46K viewsPharmaceutical 0 Votes 1 Ans What are the benefits of implementing a pharmaceutical quality system (PQS) (in accordance with ICH Q10)? 1.57K viewsPharmaceutical 0 Votes 1 Ans How will system-related inspections differ in an ICH Q8, Q9, and Q10 environment? 1.65K viewsPharmaceutical 0 Votes 1 Ans Why is FDA concerned about drug contamination with halogenated anisole compounds, such as 2,4,6-tribromoanisole (TBA)? 1.71K viewsPharmaceutical 0 Votes 1 Ans Has FDA identified the source of the halogenated anisole compounds that have contaminated drug products? 1.65K viewsPharmaceutical 0 Votes 1 Ans What is FDA’s expectation for preventing contamination of drug products with halogenated anisole compounds? 1.76K viewsDrugs 0 Votes 1 Ans Many leading analytical balance manufacturers provide built-in “auto-calibration” features in their balances. Are such auto-calibration procedures acceptable instead of external performance checks? If not, then what should the schedule for calibration be? 1.70K viewsDrugsPharmaceutical 0 Votes 1 Ans How are the employment provisions enforced? 1.71K viewsHuman Resources 0 Votes 1 Ans What are an employer’s recordkeeping requirements under the employment provisions of the ADA? 1.68K viewsHuman Resources 0 Votes 1 Ans What employers are covered by the ADA, and when is the coverage effective? 1.65K viewsHuman Resources 0 Votes 1 Ans Can I still use FMLA leave during pregnancy or after the birth of a child? 1.51K views 0 Votes 1 Ans Can I continue to use FMLA for leave due to my chronic serious health condition? 1.49K viewsHuman Resources 0 Votes 1 Ans Are there any changes to the definition of a serious health condition under the regulations? 1.42K viewsHuman Resources 0 Votes 1 Ans I have 12 months of service with my employer, but they are not consecutive. Do I still qualify for FMLA? 1.61K viewsHuman Resources 0 Votes 1 Ans If I have to miss work due to National Guard or Reserve duty, will this affect my eligibility for FMLA leave? 1.51K viewsHuman Resources 0 Votes 1 Ans What are an employer’s posting and general notice requirements? 1.70K viewsHuman Resources 0 Votes 1 Ans How soon after an employee provides notice of the need for leave must an employer determine whether someone is eligible for FMLA leave? 1.54K viewsHuman Resources 0 Votes 1 Ans Does an employer have to provide employees with information regarding their specific rights and responsibilities under the FMLA? 1.46K 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? 987 viewsPharmaceutical 0 Votes 1 Ans Do the CGMPs require a firm to retain the equipment status identification labels with the batch record or other file? Assuming each major piece of equipment has a unique cleaning and use log that is adequately retained, is it acceptable to discard these quick reference equipment labels? 1.58K viewsPharmaceutical « Previous 1 2 … 278 279 280 281 282 283 284 Next » Question and answer is powered by anspress.net
