Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Is it ok to correct an error in a record with initials and date? 1.04K viewsDrugsPharmaceutical 0 Votes 1 Ans Do we have to review the audit trail for every batch before release? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans Are paper based systems less susceptible to manipulation than computerized systems? 930 viewsDrugsPharmaceutical 0 Votes 1 Ans What should sponsors consider when using a risk-based approach for validation of electronic systems used in clinical investigations? 1.77K viewsClinical Research 0 Votes 1 Ans Under the scope of 21 CFR part 11, what will be FDA’s focus during inspections? 1.57K viewsClinical Research 0 Votes 1 Ans Does GDUFA make any changes to traditional definitions of API and FDF manufacturers? 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans Are all facilities, sites, and organizations listed above also required to pay facility fees? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is required to pay facility fees? 1.27K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the penalty for failure of a facility to pay a facility fee or self-identify? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans Do two locations of the same company have to identify separately? 1.24K viewsDrugsPharmaceutical 0 Votes 1 Ans I am a chief compliance officer whose office is located at the organization’s headquarters. I am not involved in the daily operations of our facilities. How essential is it for me to know how to code clinical diagnoses, besides knowing how to analyze deviations and ensure that policies and procedures are in place to address and correct weaknesses? 1.29K viewsHospital and Healthcare 0 Votes 1 Ans We are a home care agency, and we’ve completed our Health Information Portability and Accountability Act of 1996 (HIPAA) privacy rule preparations as a health care provider. Several sources have told us we need to have a HIPAA privacy manual for the health plans we provide employees. Can we purchase a manual or a template for this and modify it to fit our agency? A local law firm has told us that it can prepare a manual for us for $10,000–$20,000. Is there a way to develop this manual at a lower cost? 1.27K viewsHospital and Healthcare 0 Votes 1 Ans What is HIPAA’s stance on shredding confidential paper? We have a lock on our paper compactor, so there is no way for someone to break into it. We also have a confidentiality agreement from our waste contractor. Is this enough? 1.43K viewsHospital and Healthcare 0 Votes 1 Ans What is compounding, and why is it necessary? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans How is pharmaceutical compounding different from drug manufacturing? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans What is a compounding pharmacy? 925 viewsDrugsPharmaceutical 0 Votes 1 Ans Who regulates compounding pharmacies? Do compounding pharmacies follow the same regulations as drug manufacturers? Why or why not? 1.55K viewsDrugsPharmaceutical 0 Votes 1 Ans How would patients know if their medication is compounded? Knowing that, should they take any precautions, or do anything differently? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a compounding pharmacist have special training? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans When is a compounding pharmacy necessary? 1.31K viewsDrugsPharmaceutical « Previous 1 2 … 116 117 118 119 120 … 283 284 Next » Question and answer is powered by anspress.net
