Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans How CAPA is important to Deviation Management (general)? 1.48K viewsMedical Device 0 Votes 1 Ans Where can really good indepth training materials be acquired for use in US and Asian organizations with respect to Quality Management Systems and compliance, including but not limited to document controls and CAPA – medical device design and manufacturing 1.68K viewsMedical Device 0 Votes 1 Ans My question relates to the electronic signatures (CFR Part 11): When electronic data were approved by using an electronic signature and a problem with the approved data was found, am I allowed to fix it and reapprove (with electronic signature) the change. 1.51K viewsFDA 0 Votes 1 Ans 1.Whether Study sample analysis will be conducted before long term stability completion.(Bio analytical) 2.Immediately after completion of validation,long term stability in Biological matrix is required? 1.67K viewsDrugsPharmaceutical 0 Votes 1 Ans Should an Excel spreadsheet be validated that is used for trending of stability data? 1.67K viewsFDA 0 Votes 1 Ans Is there any additional steps that should be taken for ATMs for casinos? 1.79K viewsBanking and Finance 0 Votes 1 Ans Auditing Systems for 21 CFR Part 11-Validation of Software Programs – We have a GcP app on a server. When we need to install some additional utility apps and supporting app on that server such as Adobe Reader, Word and Firefox, do we need to qualify or validate these software programs? 1.47K viewsFDA 0 Votes 1 Ans If there is dead biofilm present in the water system, will this show itself with higher TOC counts? 1.60K viewsDrugsPharmaceutical 0 Votes 1 Ans Are you familiar with reports on aspergilli in hospital water systems? Any pertinence to Purified Water systems for pharma? 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans Does HIPAA permit health care providers to disclose PHI that includes criminal justice data to other public or private-sector entities providing social services (such as housing, income support, job training)? 1.64K viewsHospital and Healthcare 0 Votes 1 Ans Does HIPAA restrict the ability of law enforcement officials to use or disclose data they maintain on health or mental health indicators to help inform incident response (g., to ensure officers are prepared to stabilize individuals and/or to support diversion)? 1.54K viewsHospital and Healthcare 0 Votes 1 Ans In the context of pre-arrest diversion, when does HIPAA permit a health care provider to share PHI with a law enforcement official without an individual’s authorization? 1.69K viewsHospital and Healthcare 0 Votes 1 Ans When is an individual, other than an inmate, considered to be within the “lawful custody” of law enforcement for purposes of 45 CFR 164.512(k)(5) of the HIPAA Privacy Rule? Is “lawful custody” limited to arrest and imminent arrest or does it apply to situations where an individual may be under the care or control of an officer, but not under arrest? 1.68K viewsHospital and Healthcare 0 Votes 1 Ans Does HIPAA restrict a covered entity’s disclosure of PHI for treatment purposes to only those health care providers that are themselves covered by HIPAA? 1.37K viewsHospital and Healthcare 0 Votes 1 Ans Does HIPAA permit a doctor to contact a patient’s family or law enforcement if the doctor believes that the patient might hurt herself or someone else? 1.63K viewsHospital and Healthcare 0 Votes 1 Ans If a law enforcement officer brings a patient to a hospital or other mental health facility to be placed on a temporary psychiatric hold, and requests to be notified if or when the patient is released, can the facility make that notification? 1.54K viewsHospital and Healthcare 0 Votes 1 Ans In process validation, how important is VMP? 1.59K viewsFDA 0 Votes 1 Ans How can we qualify old equipments without any documents,though the same are working fine? 1.63K viewsMedical Device 0 Votes 1 Ans what is root cause analysis 1.81K viewsFDA 0 Votes 1 Ans how capa helps pharmaceutical industry 1.57K viewsDrugsPharmaceutical « Previous 1 2 … 64 65 66 67 68 … 283 284 Next » Question and answer is powered by anspress.net
