All Practice Exam Final (Device) Questions With Complete
Solutions
The quality assurance manager of a small company with 12
employees is the company's only internal auditor and has been
performing all internal quality system audits for three years.
This does not meet the requirements for performing internal
quality systems audits because:
A. Auditor independence has not been ensured
B. There is no one in the company qualified to train the quality
assurance manager in quality auditing principles
C. Quality system audits cannot be performed by the same
auditor for more than two audits in a row
D. The Audit Reports need to be approved by a second internal
auditor not involved with the specific audit
A. Auditor independence has not been ensured
Auditor independence has not been ensured because the quality
assurance manager is auditing areas of the quality system for
which he/she is responsible. This is not permitted.
Sponsors of a clinical trial must immediately notify FDA and
investigators of serious adverse events EXCEPT:
A. Temporally associated with the use of the investigational
item but are not serious and/or unexpected
B. Described in the Investigator's Brochure but with greater
,severity
C. Life-threatening or result in inpatient hospitalization
D. Findings from animal or in vitro testing that suggest a
significant risk in humans exposed to the drug
A. Temporally associated with the use of the investigational
item but are not serious and/or unexpected
Events that are not undesirable are not adverse events. Events in
animals are not reportable. Events of greater severity than
described in the Investigator's Brochure are unexpected and
therefore reportable.
According to 21 CFR 312.32:
Answer B should be reported 2)Unexpected fatal or life-
threatening suspected adverse reaction reports . The sponsor
must also notify FDA of any unexpected fatal or life-threatening
suspected adverse reaction as soon as possible but in no case
later than 7 calendar days after the sponsor's initial receipt of the
information.
Additionally, according to the Guidance Adverse Event
Reporting to IRBs—Improving Human Subject Protection:
An AE that is described or addressed in the investigator's
brochure, protocol or Informed Consent documents, but occurs
at a specificity or severity that is inconsistent with prior
observations should be reported.
According to 21 CFR 312.32 Answer ID 3 Should be reported:
,Increased rate of occurrence of serious suspected adverse
reactions . The sponsor must report any clinically important
increase in the rate of a serious suspected adverse reaction over
that listed in the protocol or investigator brochure.
According to 21 CFR 312.32 Answer ID 4 also should be
reported:
iii) Findings from animal or in vitro testing. The sponsor must
report any findings from animal or in vitro testing, whether or
not conducted by the sponsor, that suggest a significant risk in
humans exposed to the drug, such as reports of mutagenicity,
teratogenicity, or carcinogenicity, or reports of significant organ
toxicity at or near the expected human exposure.
FDA has conducted an initial review of your company's PMA
application and issued a set of deficiencies. A PMA amendment
has been submitted to FDA in response to the deficiencies. In
the meantime, FDA has requested a Panel Meeting for review of
the PMA. Your company has begun preparing for the Panel
Meeting. Six weeks prior to the scheduled Panel Meeting, FDA
issues a letter stating the PMA is now not approvable because
additional deficiencies have been identified and some of the
responses to the previous deficiencies are not adequate. As the
regulatory person responsible for this submission, you will
direct the project team as follows:
A. Panel Meeting will occur as scheduled, so prepare for the
meeting & at a later date respond to the recent deficiencies
B. Panel Meeting will be postponed until FDA receives adequate
, responses to the deficiencies
C. Focus all efforts on responses to the deficiencies
D. Do nothing
B. The Panel Meeting will be postponed until FDA receives
adequate responses to the deficiencies; focus all efforts on
responses to the deficiencies
The Panel Meeting would not take place as scheduled because
the PMA is considered nonapprovable until the deficiencies are
addressed. The company has 180 days to submit an amendment
to the PMA and a Panel Meeting would be rescheduled for a
later date pending the company's responses to the deficiencies.
For validated processes and systems, the possibility of
revalidation should be considered for all of the following
EXCEPT:
A. When the manufacturer tightens the specification for
container closure torque.
B. Whenever there are changes in packaging, formulation,
equipment, or processes which could impact product
effectiveness or product characteristics
C. When a change is made in raw material supplier
D. Based on procedures in the Change Control Standard
Operating Procedure.
A. When the manufacturer tightens the specification for
container closure torque.
Answers C and D are straight from the Guideline on General
Solutions
The quality assurance manager of a small company with 12
employees is the company's only internal auditor and has been
performing all internal quality system audits for three years.
This does not meet the requirements for performing internal
quality systems audits because:
A. Auditor independence has not been ensured
B. There is no one in the company qualified to train the quality
assurance manager in quality auditing principles
C. Quality system audits cannot be performed by the same
auditor for more than two audits in a row
D. The Audit Reports need to be approved by a second internal
auditor not involved with the specific audit
A. Auditor independence has not been ensured
Auditor independence has not been ensured because the quality
assurance manager is auditing areas of the quality system for
which he/she is responsible. This is not permitted.
Sponsors of a clinical trial must immediately notify FDA and
investigators of serious adverse events EXCEPT:
A. Temporally associated with the use of the investigational
item but are not serious and/or unexpected
B. Described in the Investigator's Brochure but with greater
,severity
C. Life-threatening or result in inpatient hospitalization
D. Findings from animal or in vitro testing that suggest a
significant risk in humans exposed to the drug
A. Temporally associated with the use of the investigational
item but are not serious and/or unexpected
Events that are not undesirable are not adverse events. Events in
animals are not reportable. Events of greater severity than
described in the Investigator's Brochure are unexpected and
therefore reportable.
According to 21 CFR 312.32:
Answer B should be reported 2)Unexpected fatal or life-
threatening suspected adverse reaction reports . The sponsor
must also notify FDA of any unexpected fatal or life-threatening
suspected adverse reaction as soon as possible but in no case
later than 7 calendar days after the sponsor's initial receipt of the
information.
Additionally, according to the Guidance Adverse Event
Reporting to IRBs—Improving Human Subject Protection:
An AE that is described or addressed in the investigator's
brochure, protocol or Informed Consent documents, but occurs
at a specificity or severity that is inconsistent with prior
observations should be reported.
According to 21 CFR 312.32 Answer ID 3 Should be reported:
,Increased rate of occurrence of serious suspected adverse
reactions . The sponsor must report any clinically important
increase in the rate of a serious suspected adverse reaction over
that listed in the protocol or investigator brochure.
According to 21 CFR 312.32 Answer ID 4 also should be
reported:
iii) Findings from animal or in vitro testing. The sponsor must
report any findings from animal or in vitro testing, whether or
not conducted by the sponsor, that suggest a significant risk in
humans exposed to the drug, such as reports of mutagenicity,
teratogenicity, or carcinogenicity, or reports of significant organ
toxicity at or near the expected human exposure.
FDA has conducted an initial review of your company's PMA
application and issued a set of deficiencies. A PMA amendment
has been submitted to FDA in response to the deficiencies. In
the meantime, FDA has requested a Panel Meeting for review of
the PMA. Your company has begun preparing for the Panel
Meeting. Six weeks prior to the scheduled Panel Meeting, FDA
issues a letter stating the PMA is now not approvable because
additional deficiencies have been identified and some of the
responses to the previous deficiencies are not adequate. As the
regulatory person responsible for this submission, you will
direct the project team as follows:
A. Panel Meeting will occur as scheduled, so prepare for the
meeting & at a later date respond to the recent deficiencies
B. Panel Meeting will be postponed until FDA receives adequate
, responses to the deficiencies
C. Focus all efforts on responses to the deficiencies
D. Do nothing
B. The Panel Meeting will be postponed until FDA receives
adequate responses to the deficiencies; focus all efforts on
responses to the deficiencies
The Panel Meeting would not take place as scheduled because
the PMA is considered nonapprovable until the deficiencies are
addressed. The company has 180 days to submit an amendment
to the PMA and a Panel Meeting would be rescheduled for a
later date pending the company's responses to the deficiencies.
For validated processes and systems, the possibility of
revalidation should be considered for all of the following
EXCEPT:
A. When the manufacturer tightens the specification for
container closure torque.
B. Whenever there are changes in packaging, formulation,
equipment, or processes which could impact product
effectiveness or product characteristics
C. When a change is made in raw material supplier
D. Based on procedures in the Change Control Standard
Operating Procedure.
A. When the manufacturer tightens the specification for
container closure torque.
Answers C and D are straight from the Guideline on General
