Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What food/feed safety hazards will covered facilities need to address within their food and feed safety plans? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans What preventive controls will be deemed to be effective in controlling identified “significant” hazards? 1.31K viewsHospital and Healthcare 0 Votes 1 Ans For covered facilities, will FDA’s hazard analysis and preventive controls requirements require a hazard analysis and critical control point (HACCP) plan? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Will covered facilities need to have their written food safety plans “certified” by a third-party auditor? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans Within its proposed CGMP and preventive controls rule for animal feed/pet food, FDA proposes that a “qualified individual” perform or oversee activities associated with the required food safety plan. Who is a “qualified individual?” 1.09K viewsDrugsPharmaceutical 0 Votes 1 Ans Will covered facilities need to submit their written food safety plans to FDA in advance of an inspection? 1.56K viewsDrugsPharmaceutical 0 Votes 1 Ans Does FSMA expand the traceability requirements for food? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Will covered facilities be required to have supplier verification and approval programs? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans When will FDA complete its FSMA-related rulemakings? And when will covered facilities/entities need to comply with the requirements? 1.48K viewsDrugsPharmaceutical 0 Votes 1 Ans Do we need to send a notice of privacy practices (NPP) to nursing home patients who are unable to comprehend it or read it? 1.50K viewsHospital and Healthcare 0 Votes 1 Ans A patient has an outstanding balance that he has not addressed, even though our billing department has contacted him many times. The patient recently exercised his right to obtain a copy of his medical record. Can we withhold the copy until the patient makes some sort of payment? We have always operated under the assumption that a provider cannot withhold a patient record until the patient pays his bill. Is this right? 1.47K viewsHospital and Healthcare 0 Votes 1 Ans Our hospital pays for chart abstraction for all medical staff members, regardless of the physician’s volume of referrals. It’s a time-saving benefit for the staff, but does this violate Stark or any other regulations? 1.54K viewsHospital and Healthcare 0 Votes 1 Ans Can I continue to use a patient sign-in sheet? 1.56K viewsHospital and Healthcare 0 Votes 1 Ans What about the businesses that aren’t covered entities? 1.28K viewsHospital and Healthcare 0 Votes 1 Ans How should the integrity of sterilising filters be verified? 1.37K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the sampling requirements for sterility testing when a finished product batch of a terminally sterilised medicinal product is made up of more than one steriliser load? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is responsible for performing cGMP Compliance Audits in a cGMP-licensed facility? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Why perform cGMP Compliance Audit in a cGMP-licensed facility? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans When is cGMP Compliance Audit performed in a cGMP-licensed facility? 1.63K viewsHospital and Healthcare 0 Votes 1 Ans What types of facilities are covered by FSMA? 1.40K viewsDrugsPharmaceutical « Previous 1 2 … 112 113 114 115 116 … 283 284 Next » Question and answer is powered by anspress.net
