////////////////////////////////////////////////////////////////
RAC /
Practice
/ /
Exam 1 Questions With Correct Answers
/ // // // // //
Which /
/of /
/the /
/following /
/is //NOT //required //for //compliance //under //21 //CFR //Part //11 //(electronic //records //and //electronic
//signatures)?
A/
/Manually /
/generated /
/timestamped /
/audit /
/trails /
/to /
/record /
/the /
/date /
/and /
/time //of //operator //entries //and //actions //that //create, //modify //or //delete //electronic //records.
B //Validation //of //systems //to //ensure //accuracy
C/
/Authority /
/checks /
/to /
/ensure //that //only //authorized //personell //can //create, //modify //or //delete //electronic //records.
D //Establishment //of //and //adherence //to //written //procedures //- //correct //answer(s) //✔✔ //A.
,////////////////////////////////////////////////////////////////
The /
/final /
/authority /
/for /
/ensuring /
/the /
/adequacy /
/of /
/an /
/Investigational /
/New /
/Drug /
/(IND) /
/informed /
/consent /
/document //resides //with //the: //- //correct //answer(s) //✔✔ //Institutional //Review //Board //(IRB)
A/
/sponsor /
/wishes /
/to /
/obtain /
/permission /
/from //FDA //to //submit //an //ANDA //for //a //drug //product //that //varies //from //the //Reference //Listed
//Drug /
/(RLD) /
/in /
/route /
/of /
/administration, /
/dosage /
/form, //or //strength, //but //anticipates //that //the //labeling //will //be //identical //to //that //of //the //RLD.
//What /
/process /
/should /
/be /
,////////////////////////////////////////////////////////////////
/used /
/to //apply //for //that //permission //from //FDA? //- //correct //answer(s) //✔✔ //Suitability //Petition
A //505(b)
(2) /
/NDA /
/is /
/not /
/an /
/appropriate //regulatory //submission //for //the //approval //to //market //a //- //correct //answer(s) //✔✔
//New /
/chemical /
/entity //when //the //sponsor //has //a //right //of //reference //to //all //applicable //published //studies
Distribution /
/records /
/for /
/drug //products //must //reference //or //contain: //- //correct //answer(s) //✔✔ //Name //and //address //of
//the //consignee
A //mid-
sized /
/pharmaceutical /
/company /
/negotiated /
/with /
/FDA /
/to /
/submit //
a //draft //Package //Insert //(PI) //and //patient //medication //guide //(MedGuide) //in //annotated //Word
//format /
/for /
/initial //FDA //review, //and //committed //to //submit //the //Labeling //in //Structured //Product //Label
(SPL) /
/format /
, ////////////////////////////////////////////////////////////////
/upon /
/approval /
/of /
/their /
/product. /
/What /
/is /
/the /
/preferred /
/timeline /
/for /
/this /
/pharmaceutical /
/company /
/to /
/submit /
/the //SPL //formatted //labeling //upon //product //approval? //- //correct //answer(s) //✔✔ //14 //days
Adverse /
/event /
/reporting //for //a //marketed //biologics //product //is //NOT //required //for: //- //correct //answer(s) //✔✔
//Diagnostic //non-invasive //test //kits
The /
/quality /
/assurance /
/manager /
/of //
a/
/small /
/company /
/consisting /
/of /
/12 /
/employees /
/is /
RAC /
Practice
/ /
Exam 1 Questions With Correct Answers
/ // // // // //
Which /
/of /
/the /
/following /
/is //NOT //required //for //compliance //under //21 //CFR //Part //11 //(electronic //records //and //electronic
//signatures)?
A/
/Manually /
/generated /
/timestamped /
/audit /
/trails /
/to /
/record /
/the /
/date /
/and /
/time //of //operator //entries //and //actions //that //create, //modify //or //delete //electronic //records.
B //Validation //of //systems //to //ensure //accuracy
C/
/Authority /
/checks /
/to /
/ensure //that //only //authorized //personell //can //create, //modify //or //delete //electronic //records.
D //Establishment //of //and //adherence //to //written //procedures //- //correct //answer(s) //✔✔ //A.
,////////////////////////////////////////////////////////////////
The /
/final /
/authority /
/for /
/ensuring /
/the /
/adequacy /
/of /
/an /
/Investigational /
/New /
/Drug /
/(IND) /
/informed /
/consent /
/document //resides //with //the: //- //correct //answer(s) //✔✔ //Institutional //Review //Board //(IRB)
A/
/sponsor /
/wishes /
/to /
/obtain /
/permission /
/from //FDA //to //submit //an //ANDA //for //a //drug //product //that //varies //from //the //Reference //Listed
//Drug /
/(RLD) /
/in /
/route /
/of /
/administration, /
/dosage /
/form, //or //strength, //but //anticipates //that //the //labeling //will //be //identical //to //that //of //the //RLD.
//What /
/process /
/should /
/be /
,////////////////////////////////////////////////////////////////
/used /
/to //apply //for //that //permission //from //FDA? //- //correct //answer(s) //✔✔ //Suitability //Petition
A //505(b)
(2) /
/NDA /
/is /
/not /
/an /
/appropriate //regulatory //submission //for //the //approval //to //market //a //- //correct //answer(s) //✔✔
//New /
/chemical /
/entity //when //the //sponsor //has //a //right //of //reference //to //all //applicable //published //studies
Distribution /
/records /
/for /
/drug //products //must //reference //or //contain: //- //correct //answer(s) //✔✔ //Name //and //address //of
//the //consignee
A //mid-
sized /
/pharmaceutical /
/company /
/negotiated /
/with /
/FDA /
/to /
/submit //
a //draft //Package //Insert //(PI) //and //patient //medication //guide //(MedGuide) //in //annotated //Word
//format /
/for /
/initial //FDA //review, //and //committed //to //submit //the //Labeling //in //Structured //Product //Label
(SPL) /
/format /
, ////////////////////////////////////////////////////////////////
/upon /
/approval /
/of /
/their /
/product. /
/What /
/is /
/the /
/preferred /
/timeline /
/for /
/this /
/pharmaceutical /
/company /
/to /
/submit /
/the //SPL //formatted //labeling //upon //product //approval? //- //correct //answer(s) //✔✔ //14 //days
Adverse /
/event /
/reporting //for //a //marketed //biologics //product //is //NOT //required //for: //- //correct //answer(s) //✔✔
//Diagnostic //non-invasive //test //kits
The /
/quality /
/assurance /
/manager /
/of //
a/
/small /
/company /
/consisting /
/of /
/12 /
/employees /
/is /
