questions on qm stability study

64
Q - 1: What is the purpose of a 'shelf life' study? 1-1 A. B. Determine the effects of environmental conditions on a material or batch* Q - 2: What procedure requires the creation of physical samples of a material or batch for storage under controlled conditions for a specific period of time? 1-1 A. Stability Study* B. C. Shelf Life Study* Q - 3: Identify a step in a stability study. 1-1 A. Create physical samples of material or batch* B. Store samples under controlled condition for duration of study* C. Remove sample from storage and test according to the test plan specified intervals* D. Evaluate actual life of product on basis of results of tests* Q - 4: Which of the following is an environmental condition that may impact the life of a product and which is evaluated in a stability study? A. Temperature* B. Brightness* C. Moisture* Q - 5: Identify a requirement of a stability study. 1- 1 A. Create and store physical samples for a specific time period*

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Questions on QM Stability Study

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Q - 1: What is the purpose of a 'shelf life' study? 1-1

A.

B. Determine the effects of environmental conditions on a

material or batch*

 

Q - 2: What procedure requires the creation of physical samples

of a material or batch for storage under controlled conditions for

a specific period of time?  1-1

A. Stability Study*

B.

C. Shelf Life Study*

 

Q - 3: Identify a step in a stability study.  1-1

A. Create physical samples of material or batch*

B. Store samples under controlled condition for duration of study*

C. Remove sample from storage and test according to the test

plan specified intervals*

D. Evaluate actual life of product on basis of results of tests*

 

Q - 4: Which of the following is an environmental condition that

may impact the life of a product and which is evaluated in a

stability study?

A. Temperature*

B. Brightness*

C. Moisture*

 

Q - 5: Identify a requirement of a stability study.  1-1

A. Create and store physical samples for a specific time period*

B. Remove samples from storage to test according to test plan*

C. Compare test results to life expentancy of product under

predefined reccommendations*

 

Q - 6: What is the synonym for a stability study?  1-1

A. Shelf Life Study*

 

Q - 7: A stability study can be defined on what basis? 1-2

A. Regulations relevant to the product prior to its introduction to

the market*

B. Regulations relevant to the product after its introduction to the

market*

 

Q - 8: Why is a stability study used in the R&D department? 1-2

A. Determine the ideal composition of a product to ensure it

meets the stability requirements defined for specific storage

conditions*

B. Determine the ideal packaging of a product to ensure it meets

the stagility requirements defined for specific storage conditions*

C.

 

Q - 9: The Stability Study application is integrated with what

other components?  1-2

A. Quality Management component*

B. Asset Life cycle Management component*

C. Materials Management component*

 

Q - 10: Which of the following is an activity of a stability study? 

1-4

A. Create stability study*

B. Create confirmation test initial sample*

C. Plan stability study*

D. Perform stability study tests *

E. Complete stability study*

 

Q - 11: The object pertinent to the Stability Study test is what?  2

A. Quality Notification*

 

Q - 21: What is used to trigger the individual steps of a stability

study? 2

A. Action Box in Quality Notification*

 

Q - 13: What quality notification types are used as the control

object for a stability study?  3-1

A. QS*

B. QR*

C. QT*

 

Q - 14: The criteria of a stability study from a business

perspective include what? 3-2

A.  The product to be tested*

B. The time period during which the product is tested*

C.  The conditions under which the product is stored*

D. The characteristics of the substance or product to be

evaluated*

E. The times at which the substance or product is tested*

F. The identifed effects on the substance or product of the

storage conditions*

 

Q - 15: What triggers a step in a stability study? 3-3

A. Pre-defined follow-up function in quality notificatin action box*

 

Q - 16: Which of the following is a requirement in order to create

a customer quality notificatin type for use in a stability study? 3-3

A. Customization of functions in the notification action box to

meet requirements of business processed*

 

Q - 17: Which of the following is a true statement?  3-3

A. Standard quality notification types must be used for a stability

study

B. Custom quality notification types may be used for a stability

study*

C.

 

Q - 18: Which of the following is an object that can be assigned to

a stability study depending on the particular activity of the

study?  3-4

A. Initial sample*

B. Document*

C. Stability BOM*

D. Inspection Lot for the Initial Test*

E. Inspection Lot for Stability Test*

F. Stability Sample for Storage Conditions*

G. Test Schedule*

 

Q - 19: Which of the following can be customized? 3-3

A. Notification Type*

B. Functions of Quality Notification Action Box*

 

Q - 20: The Quality Notification Type QR is used for which of the

following? 3-3

A. A stability study conducted with reference to a material

B. A stability study conducted without reference to a material*

C. Trial-related stability study

 

Q - 21: What is the purpose of the quality notification type QS? 3-

3

A. A stability study conducted with reference to a material*

B. A stability study conducted without reference to a material*

C. Trial-related stability study

 

Q - 22: What is the purpose of the quality notification type QT? 3-

3

A. A stability study conducted with reference to a material

B. A stability study conducted without reference to a material

C. Trial-related stability study*

 

Q - 23: What is the basis of the sequence of the follow-up

functions in the action box of a quality notification?  3-3

A. Logical sequence of events of stability study*

 

Q - 24: What determines if particular objects such as a sample or

a document are assigned to a stability study? 3-4

A. The particular step of the stability study that is performed*

 

Q - 25: What is the structure of the stability study object? 3-5

 

Q - 26: The stability study is performed during what phase of a

product life cycle?  4-1

A. R&D*

B. Production*

 

Q - 27: What is used to document processes in a stability study?

4-2

A. User Status*

 

Q - 28: Each activity in a stability study is documented by what? 

4-2

A. User status*

 

Q - 29: Which of the following is a true statement?  4-2

A. One to one relationship exists between step in stability study

and a follow-up action in the quality notification action box

B. One to one relationship does not exist between a step in a

stability study and a follow-up action in the quality notification

action box*

 

Q - 30: The process flow of a stability study is dependent on

what? 4-2

A. Text requirements*

 

Q - 31: Some steps in a stability study are triggered by what? 4-2

A.

B. Follow-up function in action box*

 

Q - 32: The creation of an inspection lot for the initial sample is a

step in what phase of the stability study? 5-2

A. Initiation of stability study phase

B. Initial testing phase*

 

Q - 33: The creation of a storage list is a step in what phase of the

stability test?  5-3

A. Stability study planning phase*

 

Q - 34: The creation of the inspection lot for the initial sample is a

step in what phase of the stability study?  5-2

A. Initial test phase*

 

Q - 35: The creation of an inspection plan for each storage

condition is a step in what phase of a stability study?

A. Initiate stability study

B. Initial test

C. Plan stability study*

 

Q - 36: What is the third phase of a stability study? 5-3

A. Plan Stability Test*

 

Q - 37: What determines the sequence in which the steps of a

stability study are performed?  3-3

A. The sequence of the follow-up functions in the action box of

the quality notification*

 

Q - 38: Which of the following is a true statement regarding a

status profile? 6

A. New user status can be created to reflect the processing status

of a stabilitys tudy*

 

Q - 39: Which of the following is an activity of the 'initial test'

phase of a stability study that can be triggered by a follow-up

action ? 5-2

A.  Create inspection lot for the initial sample*

B. Perform intial test

C. Record results for initial test

D. Complete initial test with usage decision for inspection lot

 

Q - 40: What is the first phase of a stability study?  5-1

 

Q - 41: How are inspection plans assigned to storage conditions?

5-3

A. Creation of test schedule*

 

Q - 42: Which of the following is an activity of the 'Initiate the

Stability Study' phase of the study?  5-1

A. Create quality notification*

B. Create a physical sample record for the initial sample*

C. Assign stability BOM to stability study (for study that

references a material)*

D. Confirm receipt by lab of initial sample*

 

Q - 43: The assignment of inspection plans to storage conditions

by processing a testing schedule is a step in what phase of the

stabilitystudy? 5-3

A. Initiate the stability study

B. Initial test for stability study

C. Create plan for stability study*

 

Q - 44: The creation of physical samples occurs in what phase of

a stability study?  5-3

A. Stability planning phase*

 

Q - 45: The placement of physical samples in storage is a step in

what phase of a stability study?  5-3

A. Stability planning phase

 

Q - 46: What is the purpose of Document Flow in relations to a

stability study?  6-

A. Display objects related to stability study*

 

Q - 47: The purpose of a stability study is what? 1-1

A. Determine the effect of specific environment conditions on

compound, material or batch over specified period of time*

 

Q - 48: The performance of the initial test is a step in what phase

of the stability study?  5-2

A. Initial test phase*

 

Q - 49: The identification of a start date for a stability study is a

step in what phase of the study?  5-3

A. Planning Phase*

 

Q - 50: The definition of storage conditions and the creation of a

testing schedule and inspection plan are steps in what phase of a

stability tudy? 5-3

A. Plan Stability Study*

 

Q - 51: The selection of the start date of a stability study is a step

in what phase of a stability study?  5-3

A. Plan stability study phase*

 

Q - 52: The maintenance of storage data for samples is a step in

what phase of a stability study?  5-3-g

A. Plan stability study phase*

 

Q - 53: The completion of the test schedule is a step in what

phase of the stabilitys tudy? 5-3

A. Plan stability plan phase*

 

Q - 54: Which of the following activities of the first phase of a

stability study that can be triggered via a follow-up function in an

action box includ which of the following?  5-1

A. Create quality notification

B. Create physical sample record for initial sample*

C. Assign stability BOM to stability study*

D. Confirm receipt fo initial sample*

 

Q - 55: The confirmation of the receipt of the initial sample at the

lab is a step of what phase of the stability study?  5-1

A. Initial Phase of stability study*

 

Q - 56: Recording test results for the initial test of the stability

study occurs in what phase of the stability study?  5-2

A. Initial Test Phase*

 

Q - 57: The quality notification is? 3-1

A. Business object used to process the activities of a stability

study*

 

Q - 58: The creation of physical samples, the creation A.

B. Stability planning phase*of labels, and the placement of samle

in storage are steps in what phase of a stability study?  5-3

A. Plan stability study phase*

 

Q - 59: The assignment of inspection plans to storage conditions,

the completion of a testing schedule, and the maintenance of

sample records are steps in what phase of a stability study? 5-3

 

 

Q - 60: The fourth phase of a stability study is what? 5-4

A. Perform stability test*

 

Q - 61: Identify the activities that related to the Stability Study

Planning Phase.  5-3

A. Creation of physical samples*

B. Placement of sample in storage*

C. Determination of start date*

 

Q - 62: The removal of samples from a storage area and the

testing of the samples are steps in what phase of the stability

study?   6-1

A. Stability Testing phase*

 

Q - 63: The completin of all tests of a stability study is a step in

what phase of a stability study? 6-1

A. Stabilty Testing phase*

B. Complete Stability Study phase

 

Q - 64: Test date monitoring is a step in what phase of a stability

study? 6-1

A. Stability Testing phase *

 

Q - 65: The creation of a batch job to create an inspectio lot is a

step in what phase of a stability study?  6-1

A.

B. Stability Testing phase*

 

Q - 66: The removal of samples from storage for testing is a step

in what phase of a stability study?  6-1

A. Stability Testing phase*

 

Q - 67: 3, 6, 9, and 12 months are examples of what?  13-1

A. Package*

 

Q - 68: Identify a restriction regarding the assignment of

inspection plans to storage conditions in a testing schedule.  13-2

A. Assigned inspection plan must use the identical strategy to

that of testing schedule*

 

Q - 69: The analysis of the processes of a stability study is a step

in what phase of a stability study?  6-1

A. Stability testing phase*

 

Q - 70: The creation of a schedule for the background job to creat

inspection lots on scheduled dates is a step in what phase of a

stability study? 6-1

A. Stability testing phase*

 

Q - 71:

 

Q - 72: Which of the following is a requirement to conduct a

stability study?  4-1

A. Creation of physical samples of material to be examined*

B.

C. Use of tests to inspect samples*

 

Q - 73: A user statust that is assigned to a stability study process

has what effect? 4-2

A. Allows a subsequent step in a stability study*

B.

C. Disallows a subsequent step in a stability study*

 

Q - 74: Identify a rule regarding the assignment of a stability

study strategy of inspection plans to storage conditions in a

testing schedule.  13-2

A. No limit to the assignment of strategy to inspection plans or

test schedule*

 

Q - 75: What is the result of the assignment of packages to an

inspection operation in an nspection plan?  13-2-a

A. Multiple sets of unique frequencies can be assigned to one

storage condition*

 

Q - 76: What determines the number of strategies that are

required to conduct a stability study?   13-2

A. Testing frequencies used in the stability study*

 

Q - 77: What is the business scenario that is usually performed in

a lab to determine the effects of particular storage conditions on

a product over a long period of time?

A. Stability study*

 

Q - 78: What assignments must be made to use a strategy to

conduct a stability study?  13-2

A. Strategy is assigned to the header of an inspection plan for a

storage condition*

B.Strategy packages are assigned to an operatin in the test

schedule in an inspection plan*

C. Strategy schedules the parameters that are assigned to test

schedule*

 

Q - 79: The set of all possible testing frequencies used in a

stability study are references where?13-2

A. Strategy*

 

Q - 80: What entries are made for a strategy in an inspection

plan?  13-2

A. Strategy is assigned to the inspection plan header*

B. Strategy packages are assigned at the operation level*

 

Q - 81: What triggers the individual processes of a stability

study?  3-3

A. Follow-up functions in the quality notification action box *

 

Q - 82: T/F It is possible to define unique operation specific test

frequencies (packages) for one storage location. 13-2

A. True*

B. False

 

Q - 83: A strategy package is assigned to an inspectio plan at

what level?   13-2

A. Header level

B. Operation Level

C. A or B *

D. Neither A nor B

 

Q - 84: Which of the following is a characteristic of a stability

study strategy?   13-3

A. Determines the sequence of planned stability tests*

B. Assigned to unlimited number of inspection plans*

C. Includes packages which identify the frequency  of test*

D. More than one strategy can be defined based on individual

testing frequency*

E. Includes the scheduling parameters and indicators*

 

Q - 85: What is included in the structure of a stability study?   13-

3

A. Header*

B. Scheduling parameters*

C. Scheduling indicators*

D. Packages*

 

Q - 86: The quality notification type 'QR' is used for what

purpose?  3-3

A. A stability study conducted with reference to a material

B. A stability study conducted without reference to a material*

C. Trial-related stability study

 

Q - 87: The quality notificatin type 'QS' is used for what purpose? 

3-3

A. A stability study conducted with reference to a material*

B. A stability study conducted without reference to a material

C. Trial-related stability study

 

Q - 88:

 

Q - 89: The activities of a stability study 'completion ' phase that

can be triggered by a follow-up function in an action box include

what? 6-2

A. Cancel Study*

B. Deactivate study*

C. Complete study

 

Q - 90: The completion of a stability study consits of what

activity?  6-2

A. Complete stability study*

B. Cancel stability study for some storage conditions*

C. Deactivate study for some storage conditions*

 

Q - 91: Identify a parameter for a stability study strategy.  13-4

A.

B. Scheduling indicator that controls the execution of a time

based test strategy*

C. Call Horizon*

 

Q - 92: 13-4

 

Q - 93: 13-4

 

Q - 94: A stability study strategy is identical to which of the

following?   14-2

A. Maintenance strategy*

 

Q - 95: Monitoring testing dates is a step in what phase of a

stability study? 6

A. Stability testing phase*

 

Q - 96: The cancellation of a stability study for one or more

storage conditions is a step in what phase of a stability study?  6-

2

A. complete stability study phase*

 

Q - 97: Which of the following is a required entry for the creation

of a stability study strategy? 

A. Name*

B. Description*

C. Scheduling indicator*

D. Strategy unit value*

E. Call horizon value*

 

 

Q - 98: What is the function of a quality notification in relation to

a stability study?  16

A. Creates a stability study*

B. Documents intent to conduct stability study*

 

Q - 99: The creation of physical sample record for the initial

sample and the confirmatin of receipt of the initial sample are

steps in what phase of a stability study?5-1

A. Initiate Stability Study phase*

 

Q - 100: What is the function of a physical sample record that is

created for an initial sample?   16-2-2

A. Created prior to receipt of physical samples*

 

Q - 101: What step of the 'initiating stability study' phase must be

completed prior to the inspection of the initial sample?  16-2

A. Confirmation of receipt of initial sample*

 

Q - 102: What is the business object used to process the activities

of a stability study? 3-1

A. Quality Notification*

 

Q - 103:'Initiating a Stability Study' is a phase that immediately

precedes what other phase?  16-3

A. 'Initial test' phase*

 

Q - 104: What is the purpose of the quality notification type 'QR'? 

17-2-2

A. Stability study without a material*

B. Stability study with a material

 

Q - 105: Which of the following is a prerequisite to the creation

and conduct of a stability study?  17-1

A. Creation of notification to document the intent to conduct the

stability study*

 

Q - 106: Which of the following is required to create a stability

study?  17

A. Notification type*

B. Stabililty Study Identifier*

C. Material number*

D. Client

E. Inspection Lot Number

 

Q - 107: What is the first step of the 'Initiate Study' phase of the

stability study? 17-1

A.

B. Create stability study *

 

Q - 108: What method can be used to create the key for a

stability study? 17-2-3

A. Internal number assignment*

B. External number assignment*

 

Q - 109: Which of the following is included in a stability study

inspectio plan?   25-2

A. Characteristics to be tested in the study*

 

Q - 110: What is the purpose of performing the inspection of the

initial sample?  25-1

A. Ensure that the test of the sample meets the requirements of

the study*

B. Ensure that the sample meets the requirements of the study*

 

Q - 111: The confirmation of the receipt of the initial sample is a

step in what phase of the stability study?  23-1

A. 'Initiate Stability Study' phase*

 

Q - 112: The specification of the storage conditions for samples is

a step in what phase of the stability study?    5-3-4

A. Initiate stability study

B. Initial Test

C. Stability Planning*

D. Stability Testing

E. Completing Study

 

Q - 113: What is the purpose of a physical sample record in

relation to a stability study?  10

A. Means to identify the physical samples created and processed

in a stability study*

 

Q - 114: What is the purpose of a physical sample drawing

number in relation to a stability study?  10-1

A. Means to identify a physical sample that is created and

processed in a stability study

B. Means to identify all physical samples that is created and

processed in a stability study*

 

Q - 115: Which of the following is a type of record created when a

stability study is processed?  10-1

A. Stability study (Quality Notification)*

B. Physical Sample Drawing Number*

C. Individual Physical Sample Record*

 

Q - 116: A physical sample drawing includes a reference to what? 

10-2

A. Stability study*

 

Q - 117: Which of the following is included in a stability study

storage list?  44-1

A. Description of each storage condition*

B. Description of the physical sample associated with each

storage condition*

C. Planned Quanity of physical samples created for each storage

condition*

D. Number of test performed for each storage condition*

E. Storage location for each stability sample*

F. Actual quantity of physical samples created for each storage

condition*

 

Q - 118: Description of sample defined for each storage condition,

number of test performed for each storage condition, and

description of storage condition are examples of what?   44-1

A.Data included in stability study storage list*

 

Q - 119: The storage list will indicate what quantity of physical

samples if a testing schedule is not completed?  44-2

A. '0' quantity*

 

Q - 120: Why does a storage list indicate a '0' quantity of physical

samples prior to the completion of a testing schedule?  44-2

A. Testing schedule is required to calculate physical sample

quantities for each storage condition*

  Maintaining storage data for each stability sample in the system

is a step in what phase of a stability study?  46

A. Plan stability test phase*

 

Q - 121: What is the resul of the creation of storage data for each

stability study?  46-2

A. Stability sample is released for each storage condition and

stability study can be initiated*

B. Storage data is documented by the system*

 

Q - 122: Identify a prerequisite to the calculation of physical

sample quantities for each storage condition?  44-2

A. Completion of testing schedule*

 

Q - 123: What is a prerequisite to maintaining storage data?  46-3

A. Storage conditions specified in the stability study*

 

Q - 124: Activities of the 'complete the stability study' phase that

can be triggered by follow-up functions include which of the

following?  6-2

A. Cancel study for all storage conditions*

B. Deactivate study for all storage conditions*

C. Enter usage decision for sample *

 

Q - 125:T/F Custom user statuses can be defined. 8

A. True*

F. False

 

Q - 126: The system status assigned to the stability study is an

indication of what?  7-2

A. Documents the steps of the study that have been performed*

B. Infers steps of the study that can be performed*

C. Infers steps of the study that cannot be performed*

 

Q - 127: The user status is documented where? 7-1

A. Quality notification header*

B. Quality notification item

 

Q - 128: The creation of a quality notification is a step in what

phase of a stability study?  5-1

A. Initiate the stability study phase*

 

Q - 129: One stability test is completed for which of the

following?  29-1

A. Each lot for each storage condition*

 

Q - 130: When a usage decision for an inspection lot is made,

which of the following can occur?  29-1

A. Study can be continued for the storage condition*

B. Stability study can be completed or deactivate for a storage

condition on a temporary basis*

C. Stability study can be completed*

 

Q - 141: What is the last step of a stability study?  6-2

A. Complete stability study*

 

Q - 142: Any activity that can be performed following the entry of

a usage decision is controlled by what?   29-2-1

A.  Follow-up action that is executed when a usage decision is

made for an inspection lot *

 

Q - 143: The deactivation of a stability study for one or more

storage conditions is a step in what phase of a stability study?  6-

2

A. Complete stability study phase*

 

Q - 144: The assignment of a stability BOM to a stability study

relates to what phase of a stability study?  5-

A. Initiate stability study phase*

 

Q - 145: What is the prerequisite to the completion of a stability

study?  29-2

A. Test Results have been recorded for inspection characteristics*

 

Q - 146: What is the result of the completion of an inspection test

for storage condition for inspection lot with a usage decision to

discontinue the study?  31

A.Stability study can be cancelled or completed*

 

Q - 147: What is included in the print copy of a storage list for

stability samples? 32-3-6

A. Quantity of samples required for each stability sample*

B. Storage conditions for each sample*

 

Q - 148: What is the result of the completion of a testing

schedule?   32-3-5

A. Status of stability study is updated to reflect the completion of

scheduled activities *

 

Q - 149: Which of the following is a valid follow-up action for a

usage decision for an inspection lot for a stability test? 29-2

A. Complete initial test*

B. Confirm stability inspection lot*

C. Complete or cancel stability study*

D. Lock sample for storage condition*

 

Q - 150: What is the objective of processing a testing schedule? 

32-3-4

A. Assignment of inspectio nplan to each storage condition item

in the schedule*

 

Q - 151: What is a result of the creation of a testing schedule for

a stability study? 32-3-3

A. The creation of an item in the testing schedule for each

storage condition that is specified i the stability study*

 

Q - 152: What is a stability study strategy?  13-1

A. Test schedule that can be assigned to an unlimited number of

inspection plans*

B. Determines the chronological sequence of planned stability

tests*

 

Q - 153: Why is the asseignment of the inspection plan to each

storage condition in a testing schedule required?   32-3-4

A. Calculation of quantities to be placed in storage to serve as

stability samples*

 

Q - 154: Which of the following is a true statment?  13-1

A. A strategy can be assigned to an unlimited number of

inspection plans for a storage condition*

B. A strategy can be assigned to an unlimited number of testing

schedules*

 

Q - 155: The 'packages' referred to in a stability study strategy

are used for what purpose?  13-1

A. Specify the frequency with which individual tests are

performed*

 

Q - 156: A package is an element of what? 13-1

A. Strategy*

 

Q - 157: Why is it possible to define multiple, operation-specific

testing frequencies for one storage location?   13-1

A More than one package can be assigned to an inspection

operation*

B. A package specifies the test frequency

 

Q - 158: One physical sample drawing number refers to what?  10

A. All physical sample records for an initial sample*

B. all physical sample records for stability samples*

 

Q - 159: What is used to determine the frequency with which

tests in a stability study are performed?  13-1

A. Packages*

 

Q - 160: T/F Testing dates can be defined for a study before or

after a stability study is initiated.  11-2

A. True*

B. False

 

Q - 161: Basic data that is defined for a stability study includes

whichof the following?   11-2

A. Storage conditions to be tested*

B. Scheduling strategies*

Q - 162:

 

Q - 163: The inspection of an initial sample is a step in what

phase of a stability study?  5-2

A. Initial testing phase*

B. Initiation of the stability study

C. Stability test

 

Q - 164: Which of the following is the second phase of a stability

study?  5-2

A.

B. Initial Test phase*

 

Q - 165: The entry of the usage decision for an inspection lot for

an initial sample is a step in what phase of a stability study?  5-2

A. Initiate Stability Study

B. Initial Test Phase*

C. Stability Test

D. Stability Planning

E. Completion of Stability Study

 

Q - 166: The activities of the initial testing phase of a stability

study include which of the following?  5-2

A. Create inspection lot for initial sample*

B. Perform Initial Test*

C. Record Test Results*

D. Complete initial test with usage decision for inspection lot*

 

Q - 167: The basic data for a stability study includes which of the

following?  11-1

A. Storage conditions to be tested*

B. Scheduling strategies*

 

Q - 168: A scheduling strategy includes which of the following? 

11-1

A.  Time intervals*

B. Times Bases*

 

Q - 169: What is the first step in planning a stability study?  12

A.

B. Selecting a storage condition*

 

Q - 170: Which of the following is a step in the 'process stability

test' phase of a stability study?  48

A. Print physical sample labels*

B. Attach labels to physical samples*

C. Place samples in storage*

 

Q - 171: The creation of a physical sample record for the 'initial

sample' is a step in what phase of a stability study?  5-1

A. Initiate the stability study*

 

Q - 172: Which of the following is an example of a storage

condition?  12-1

A. Temperature*

B. Humidity*

C. Light*

D. Atmospheric Pressure*

 

Q - 173: What is a 'storage condition'? 12-1

A. Description of an attribute of the environment in whcih the

material or product is stored *

 

Q - 174: How is a storage condition defined?

A. Master record

B. Customizing*

 

Q - 175: Which of the following is a prerequisite to planning a

stability test?  12-2

A. Storage conditions defined in IMG*

 

Q - 176: What is the significance of a storage condition to a

stability study?  12-2

A. A stability study examines the effects of individual storage

conditions on specific characteristic of a material over an

extended period of time*

 

Q - 177: A 'month' is an example of what in relation to a stability

study?  11-2

A. Time Base

B. Time Interval*

C. Strategy

D. Package in Strategy

 

Q - 178: A 5-year period is an example of what/  11-2

A. Time base in stability study strategy*

B. Time interval in stability study strategy

C. Strategy

D. Package

 

Q - 179: What is a package in relation to a stabiity study?  11-2

A. Basic data for a stability study*

B. Time interval for a stability study*

 

Q - 180: How is a physical sample drawing number created?  10-2

A. Automatically created when initial sample is created*

 

Q - 181: What is a prerequisite to create an inspection lot for the

initial sample?  26-2

A. Inspection plan with characteristics required for the initial test*

B. Plan to process physical samples*

 

Q - 182: 26-2 requirement to process physical samples

 

Q - 183: What is the effect of the completion of the initial test

with a usage decision for the inspection lot?  25-4

A.  An acceptance leads to the continuance of the stability study

and the need to plan stability tests*

B. A rejection leads to the discontinuance of the stability study

and the initiation of follow-up functions by means of the action

box in a quality notification*

C.

 

Q - 184: A stability study must be completed for which of the

following?  25

A. Each storage condition in the study*

 

Q - 185: What completes a test for a storage condition in a

stability study? 25

A. Entry of usage decision for inspection lot*

 

Q - 186: Identify a characteristic of a physical sample drawing

number.  10-2

A. One physical sample drawing number is associated with all

physical samples processed in the study*

B. The physical sample drawing number is created automatically

when an initial sample is created*

C. A physical sample drawing number is associated with both

initial samples and stability samples*

D. All physical sample records refer to one physical sample

drawing number*

 

Q - 187:  What is the purpose of the 'cal horizon' scheduling

parameter in the structure of a 'strategy'? 13-3

A.

B. Determines the start date of a test on basis of planned

date......*?

 

Q - 188: What types of samples are referenced by one physical

sample drawing number?  10-2

A. Initial sample

B. Stability sample

 

Q - 189: What is the effect of the creation of an inspection lot for

an initial sample? 27-2

A. Inspection lot is created  to which inspection characteristics

are assigned*

B. Initial sample is inspected*

C. Inspection results are recorded*

D. Inspection lot is completed for the initial test*

 

Q - 190: What activity completes the initial test? 28-1

A. Entry of usage decision*

 

Q - 191: Which of the following is a valid usage decision code that

is used to complete an initial test? 28-1

A. Complete initial test - study will be continued*

B. Complelte initial test - study will not be continued*

C. Do no complete initial test - study will not be continued

 

Q - 192: The user status is set automatically following a usage

decision by what means?  28-2

A. The follow-up action triggers the entry of the status 'Initial Test

Completed'*

 

Q - 193: Identify a prerequistie to the completion of an initial

test.  28-2

A.  Record inspection results for characteristics*

B. Valuate and close characteristics *

C.

 

Q - 194: What determines that stability test is not continued

following the initial test phase of the study? 28-1

A. Entry of usage decision - complete initial test: study should not

be continued*

 

Q - 195: T/F The user status that is triggered by the completion of

the initial test depends on the usage decision for the inspection

lot.28-2

A. True

B. False*

 

Q - 196: Which of the following can occur following the entry of a

usage decision for an initial study of a stability study?  29-1

A. Stability study is continued for storage condition*

B.

C. Stability study is deactivated on a temporary basis*

D. Stability study is completed*

 

Q - 197: What effect is achieved by the entry of the usage

decision for an inspection lot? 29-2

A. Stability study is completed for a storage condition*

 

Q - 198: Identify a required assignment to an inspection plan. 32-

3-2

A. Assign strategy to inspection plan header*

B. Assign package(s) in strategy to inspection operation(s)   *

 

Q - 199: What is the effect of the selection and assingment of a

storage condition to a stability study? 32-3-1

A. Physical sample record is automatically created to document

the stability sample to be stored and tested under the specified

storage conditions*

 

Q - 200: What determines that stability test is continued following

the initial test phase of the study? 28-1

A. Entry of usage decision - complete initial test: study should be

continued*

 

Q - 201: An inspection plan is created for which of the following? 

32-3-2

A. Each storage condition identified in the stability study*

B. The stability study

 

Q - 202: What is the third step of the stability study?  32

A. Plan stability study*

 

Q - 203: What is a prerequisite to the 'Plan Stability Study' phase

of a stability study?  32-2

A. Create initial sample*

B.

C. Define storage conditions*

D. Create strategy*

 

Q - 204: What is one purpose of the scheduling and deadline

monitoring function of the stability study?  33-2

A. View test dates for stabilitys study*

 

Q - 205: On what basis are the testing dates for the duration of

the study calculated?  33-2

A. Start date specified in the stability study*

 

Q - 206: Which of the following is an element in the stability study

structure?  34-3

A.Header in which the maintenance strategy scheduling

information is assigned to the test schedule*

B. Items created by follow-up function for each storage condition

defined for the stability study*

 

Q - 207: What data is maintained for the testing schedule item for

each physical sample associated with a storage condition? 3-2

A. Inspection type that is assigned to inspection lot*

B. Inspection plan that is assigned to each storage condition*

 

 

Q - 208: 34-4-2

 

Q - 209: 34-3-1

 

Q - 210: What method is used to create a testing schedule? 34-2

A. Follow-up function defined for stability study*

 

Q - 201: What is a stability study test schedule?  34-1

A. Object used to plan the scope and frequency of stability tests*

B. Object used to determine the storage conditions to be tested,

testing dates and inspection plans to be used??*

 

Q - 202: What is determined by a testing schedule? 34-1

A. Frequency of stability tests*

B. Scope of stability tests*

 

Q - 203: Which of the following is defined for a stability test?  34-

1

A. Scope of stability test*

B. Storage condisions to be tested*

C. Test dates*

D. Inspection plans*

E. Frequency of stability tests*

 

Q - 204: The scope of stability study testing as specified in the

testing schedule refers to what?  34-1

A. Storage condisions to be tested*

B. Testing dates*

C. Inspection plans*

 

Q - 205: A testing schedule is created for which of the following? 

34-2

A. Study that tests storage conditions in predefined intervals*

 

Q - 206: Which of the following is a true statement? 34-2

A. A testing schedule is assigned to any stability study

B. The one stability study for which it is created*

 

Q - 207: What method is used to create a stability study testing

schedule?  34-2

A. Follow-up function in stability study*

 

Q - 208: How does the assignment of an inspection plan to a

storage condition occur?  34-2

A. Testing schedule*

 

Q - 209: What is the relationship between the number of items in

a test schedule to the number of storage conditions in a stability

study?

A. One to one relationship between an item in the schedule to a

storage condition specified in a stability study*

 

Q - 210: A stability study requires that an inspection plan be

assigned to which of the following?  34-2

A. A storage condition defined for the stability study

B. Each storage condition defined for the stability study*

 

Q - 211: An item in a testing schedule is defined for which of the

following?  34-2

A. Each storage condition in a stability study*

 

Q - 212: Which of the following is an element in a testing

schedule?  34-3

A. Header*

B. Item*

 

Q - 213: The header of a testing schedule includes which of the

following?  34-3-1

A. Scheduling data retrieved from the assigned maintenance

strategy*

 

Q - 214: An item in a testing schedule is automatically calculated

for which of the following?  34-3-1

A. Each storage condition in the strategy*

 

Q - 215: T/F  A follow-up function in the stability study can be

used to create a testing schedule. 34-3-2

A. True*

B. False

 

Q - 216:  What is maintained for each testing schedule item? 

A. Inspection type used to create the inspection lots for each

storage condition*

B. Inspection plan used to inspect the storage condition*

 

Q - 217: Which of the following describes a testing schedule?  35-

2

A. Time-based strategy*

 

Q - 218: On what basis are test dates automatically calculated

using a follow-up function?  35-3

A. Start date for the stability study*

 

Q - 219: A testing schedule is a type of which of the following? 

35-2

A. Maintenance plan*

 

Q - 220: The creation of inspection lots for specified dates occurs

on what date?  35-4

A. Planned date as specified in test schedule*

B. Data calculated on the basis of lead time* ?????

 

Q - 221: What is the result of the completion of the test schedule

for a stability study?

A. Status of stability study confirms that activity is completed*

 

Q - 222: What is a prerequisite to the assignment of storage

conditions in a stability study?  36-2

A. Definition of storage conditions....*

 

Q - 223: How is a storage condition selected for a stability study? 

36-3-3

A. Follow-up function in quality notification defined for stability

study*

 

Q - 224: What is the effective quantity of physical samples for a

storage condition?  36-3-5

A. Quantity for a specific storage condition * Number of planned

tests for the storage condition*

 

Q - 225: What is the result of specifying the storage condition in a

stability study?  36-4

A.

B. Storage condition is stored in the stability study*

C. Physical sample is automatically created for each storage

condition*

 

Q - 226: What is the purpose of the physical sample record?

A. Identify  a physical sample to be stored under the defined

storage condition*

 

Q - 227: What is required to create a test schedule?  37-1

A. Storage conditions specified in a stability study*

B. Scheduling period defined in stability study*

C. Inspection type defined*

D. Strategy defined*

 

Q - 228: What activities are performed using the test scheduling

function? 37-1

A. Create test schedule*

B. Revise test schedule*

 

Q - 229: Which of the following can occur following the creation of

a testing schedule?  38-2

A. Test schedule can be processed to assign an inspection  plan

to each storage condition*

 

Q - 230: Identify the elements of an inspection plan created for a

stability study. 39-2

A. Header*

B. Operation*

C. Package*

D. Characteristic*

 

Q - 231: Which of the following is a prerequisite to processing the

testing schedule?  40-2

A. Creation of an inspection plan for each storabe condition*

 

Q - 232: What occurs when a test schedule is processed? 41

A. Assignment of inspection plan to each storage condition or

item in test schedule*

 

Q - 233: What occurs following the assignment of an inspection

plan to a storage condition? 42-2

A. Completion of the testing schedule*

 

Q - 234: What occurs following the completion of a test schedule?

43-4

A. Print the storage list*

 

Q - 235: Which of the following is included in a stability study

storage list?  44-1

A. Description of each storage condition*

B. Description of the physical sample associated with each

storage condition*

C. Planned Quanity of physical samples created for each storage

condition*

D. Number of test performed for each storage condition*

E. Storage location for each stability sample*

F. Actual quantity of physical samples created for each storage

condition*

 

Q - 236: Identify a prerequisite to printing physical sample

labels?  48-2

A. Release of stability samples for storage conditions*

 

Q - 237: Identify a prerequisite to the definition of a start date for

a stability study.  49-1

A. Completion of test schedule*

B. Storage of stability samples under specified conditions*

 

Q - 238: T/F The definition of a start date for a stability study is a

follow-fup function.  49-1

A. True*

B. False

 

Q - 239: Identify a restriction related to the definition of the start

date for a stability study.  49-1

A. Date must not lie in the future*

B. The storage date of the initial sample must be prior to the start

date of the stability study*

 

Q - 240: What must occur prior to the completion of a test

schedule?  43-2

A. Assignment of inspection plan to each storage condition in the

test schedule*

 

Q - 241: What is the result of the definition of a start date for a

stability test?  49-4

A. Calculation of test dates for the duration of the stability study*

 

Q - 242: Which of the following refers to the duration of a stability

study? 49-4

A. Scheduling periodof in the testing schedule*

 

Q - 243: What is used to ensure the system creates an inspection

lot for each storage condition when the due date of a stability

study is reached?  50-2

A. Deadline monitoring*

 

Q - 244: The performance of a stability test includes which of the

following?  50-3-4

A. Selection of the inspection lot for the test using the work list

for results recording*

B. Inspection of sample for a storage condition and recording

results for characteristics*

C. Complete test with a usage decision for the inspection lot*

 

Q - 245: Work list 50-3 4a

 

Q - 246: Complete stability study  50

 

Q - 247: Remove stability samples from storage  50

 

Q - 248: Which of the following is a prerequisite to the

performance of a stability study?  50-2

A. Definition of the start date for a stability study*

 

Q - 249: perform stability test   50

 

Q - 250: What is used to view and process test dates for planned

stability tests?  51-1

A. Test Scheduling functions*

B. Deadline monitoring functions*

 

Q - 251: On what basis are due dates for stability tests

calculated?  51-2

A. Assigned packages*

B. Scheduling parameters in test schedule*

 

Q - 252: Which of the following is a method used to display or

process test dates that should be processed?51-2

A. Test Schedule Display function*

B. Scheduling functions*

 

Q - 253: Deadline monitoring functions are initiated at regular

intervals by what?  51-3

A. Planned Report *

 

Q - 254:Identify a function performed by the 'planned report'

used in deadline monitoring? 51-3-2

A. Monitor due dates for planned stability tests for a defined time

period*

B. Create inspection lots for test dates as they become due*

 

Q - 255: Scheduling overview   51-4

 

Q - 256: What is the purpose of scheduling evaluations?  51-4

A. Monitor test dates by means of a worklist*

 

Q - 257: What is displayed in the 'Packages in Inspection Plan'

list?  61-1

A. released inspection plans with inspection operations and

assigned packages*

 

Q - 258: What report is used to determine the packages that have

been assigned to operations or operations to which packages

have not been assigned?  61-1

A Display Packages in Inspection Plans list*

 

Q - 259: True/False   The definition of a start date for a stability

study is a follow-up function in a quality notification action box. 

49-3

A. True*

B. False

 

Q - 260: The 'scheduling function' is _______? 51

A. First step of the Perform Stability Test phase*

 

Q - 261: The automatic deadline monitoring function controls

what?  51-3

A. Creation of inspection lots for test dates*

 

Q - 262: Identify a prerequisite to the creation of a scheduling

overview.  53-2

A. Start date is defined for the study*

B. Test dates are scheduled*

 

Q - 263: Identify a purpose of deadline monitoring report. 44-1

A. Monitor test dates for testing schedule*

B. Create inspection lots for test dates*

C. Update test schedule*

 

 

Q - 264: Which of the following can occur following the creation of

an inspection plan for a storage condition?  40-2

A. Process a testing schedule*

 

Q - 265: Identify a requirement to start deadline monitoring at

regular intervals?  55-2

A. Create report variant containing selection criteria for the

execution of a planned report*

B. Create a background job that specifies dates or intervals of job

execution*

 

Q - 266: T/F The deadline monitoring planned report can be an

automated or manual process. 55-2

A. True*

B. False

 

Q - 267: Identify a pre-requisite to deadline monitoring for a

stability study.  55-3

A. Define start date for stability study*

 

Q - 268: What is the 'scheduling overview list'? 58-1

A. Workplace-related list of all test dates for selected testing

schedule items*

 

Q - 269: stability study history list   60-1

 

Q - 270: As inspection plan should be created for which of the

following?  40-12

A. Each storage condition*

 

Q - 271: The creation of a testing schedule to reflect the desired

scope and frequency of tests is a step in what phase of the

stability test? 5-3

A. Initiate Stability study

B. Initiate tests

2

A. Automatic assignment following creation of test schedule*

 

Q - 273: Identify a follow-up functin accessed by the quality

notification action box?  62-4

A.Complete*

B. CAncel*

C. Deactivate*

 

Q - 274: Identify a method used to complete a stability study.  62-

1

A. Complete study as planned*

B. Cancel study*

C. Deactivate study*

 

Q - 275: Identify a result of the completion of a stability study. 

62-2

A. User status is set ot complete*

B. Test schedule is deactivated*

C. Physical samples are locked*

 

Q - 276: When are stability study samples removed from

storage?  62-4

A. Completion of study*

B. Cancellation of study*

C. Deactivation of study*

 

Q - 277: Identify a prerequisite to the completion of a stability

study.  63-2

A. No test date remains open in the schedule*

 

Q - 278: How is the removal of a sample from storage triggered? 

64-1

A. Follow-up function in study*

 

Q - 279: What method is used to deactivate and reactivate a

stability study?  65-1

A. Follow-up function*

 

Q - 280: What does the 'X' status of a stability study sample

mean?  68-2

A. Physical sample no longer exists*

 

Q - 281: Identify a determinant of the procedure used to add a

storage condition to a stability study? 71

A. Activities that have been performed to date*

 

Q - 282: What is an inspection lot in relation to a stability study?

A. Record used to process a stability  test*

 

Q - 283: How is a stability study inspection lot created?

A. Scheduling objects are executed to determine test dates*

 

Q - 284:What is the purpose of a stability study scheduling

object?

A. Determine test dates*

 

Q - 285: What is the significance of a quality notification in

relation to a stability study?

A. Manage activities of a stability study*

 

Q - 286: the creation of a testing schedule to reflect the desired

scope and the frequency of tests is a step in what phase of a

stability test?  5-3

A. Initiate stability study

B. Initiate test

C. Stability planning*

D. Stability test

E. Complete stability study

 

Q - 287: Whiat is the processing step that follows the completion

of an inspection lot for the initial test? 31-2

A. Accpetance usage decision leads to continuting the study and

planning the stability tests

B. Rejection usage decision leads to cancellation of the study or

completing the study*

 

Q - 288: Identify a step in a stability study that occurs after the

creation of a stability study.  18-2

A. Create initial sample*

B. Assign stability BOM to study*

C. Confirm initial sample*

 

Q - 289: The second step of the first phase of a stability study is

which of the following? 19=1

A. Create initial sample*

 

Q - 290: The physical sample to be tested is delivered to the lab

at what point in the stability study? 19

A. After the creation of the study*

B. Before the creation of the study

C. A or B

 

Q - 291: Which of the following is a prerequisite to the creation of

an initial sample? 

A. Creation of stability study*

 

Q - 292: Which of the following describes the initial sample?  19-1

A. Physical sample subject to a stability test that determines the

suitability of the sample for a stability study**

B. Sample delivered t lab following creation of the stability study*

 

Q - 293: What is a possible source of material for the stability

study?  19-1

A. Identifcal supply of materials from which initial sample is

selected*

B. Different supply of materials than that from which initial

sample is selected*

 

Q - 294: Which of the following is true regarding the creation of a

physical sample record for an initial sample? 19-1

A.  Function is documented in the quality notification*

B. Physical sample record status is updated*

 

Q - 295:  What is represetned by a physical sample record?  19-1

A. The plan for the receipt of the initial sample by the test

facility*

 

Q - 296: What is a stability BOM?  21-1

A. comonents or ingrediants of a material or product to be

tested*

 

Q - 297: What is required by the receipt of the initial sample?  23-

1

A. Confirm the receipt of the sample by the execution of a follow-

up function in an action box*

 

Q - 298: Which of the following refers to the confirmation of the

initial sample?  23-2

A. Record inspection results during initial test????

 

Q - 299: What is a restriction related to the confirmation of the

initial sample function? 23-1

A. The activity can be performed one time only*

 

Q - 300: What is the difference between the creation of an

inspection plan for an initial test and for a stability test?  25-2

A. Inspection plan for initial test can be created using QM function

or Engineering Workbench*

B. Inspection plan for stability study can be created with

Engineering Workbench*

 

Q - 301: The 'confirmation of an initial sample' is documented as

what?  23-2

A. Task in quality notification*

 

Q - 302: Which of the following may be required to confirm the

receipt of the physical sample in the lab? 23-2

 A. Digital signature*

 

Q - 303: What is a requirement to confirm the initial sample?  23-

2

A. Creation of stability study*

B. Creation of the initial sample*

 

Q - 304: Which of the following is a step in the second phase of a

stability study?  25-1

A. Create, confirm, test initial sample*

 

Q - 305: Which of the following is a method that can be used to

create an inspection plan for a stability study?  25-2

A. Engineering Workbench*

B. QM function*

 

Q - 306: What is the objective of the the inspection of the initial

sample of a stability study?  25-1

A. Determine by inspection results if initial samples meet the

requirements of the study prior to the conduct of the stability

tests*

 

Q - 307: Identify a requirement to perform the initial test of a

stability study.  25-2

A. Create stability study*

B. Create initial sample*

C. Confirm initial sample*

Create inspection plan with inspection characteristics*

 

Q - 309: The functions of the Engineering Workbench can be used

for which of the following?  25-2

A. Creation of an inspection plan for an initial test of a stability

study*

B. Creation of an inspection plan for the stability study*

 

Q - 310: What activity occurs subsequent to the creation of a

physical sample record? 20-2

A. Confirm receipt of physical sample*

B. Assign stability BOM

C. Create inspection lot for initial sample*

D. Define storage conditions for stability samples*

E. Create test schedule*

 

Q - 311: What is the effect of the creation of a physical sample

record? 19-1

A. Task is documented in quality notification*

B. Status in physical sample record is unpdated*

C. Data retrieved from stability study and entered to physical

sample record*

 

Q - 312: What is the effect of the confirmation of the initial

sample?  23-1

A. System confirms the physical sample drawing*

B. System updates physical sample record*

C. Initial sample is released*

 

Q - 313: Which of the following is an activity of the stability

planning phase that can be triggered by a follow up function for a

stability study? 5-3

A. Define storage conditions*

B. Create test schedule*

C. Assign inspection plans to storage conditions*

D. Complete test schedule*

E. Maintain data for storage samples*

F. Calculate test dates*

 

Q - 314: Identify a step in the performance of the initial test. 35-3

A. Create inspection lot for initial sample*

B. Select inspection lot in worklist for results recording*

C. Inspect initial sample and record inspection results*

D. Complete initial test with usage decision for the inspection lot*

 

Q - 315: Identify a function performed by the automatic deadline

monitoring planned report..  51-3

A. Due dates for stability test are monitored for specified time

period*

B. Inspection lot is created for each storage condition for due

dates of test*

 

Q - 316: What statement is true regarding a stability study

strategy? 13-2

A. Strategy is assigned to inspection plan*

B. Strategy packages assigned to inspertion operation*

C.

 

Q - 317: Which of the following is an activity of the performance

of an initial test of a stability study?  25-3

A. Create inspection lot for initial sample*

B.  Inspect initial sample and record results*

C. Complete initial test with usage decision for inspection lot*

 

Q - 318: Which of the following data is maintained for each

sample to be stored under a storage condition?  46-1

A. Quantity of each sample to be placed in storage*

B. Storage Date*

C. Location of storage condition *

D. Number of physical sample labels*

 

Q - 319: Which of the following is an object used in a stability

study?

A. Quality notification*

B. Test Schedule*

C. Physical sample record*

D. Inspection lot*

E. Scheduling object*

 

Q - 320:  What is a storage removal list?  67-1

A. List of samples for all storage conditions and their processing

status*

B.

 

Q - 321: What is the result of the completion of a stability study? 

63-4

A. Test Schedule is locked*

B. Physical samples are locked*

C. Lots that are not completed are cancelled*

D. Usage decision closes characteristic*

E. Print storage removal list*

F. Samples removed from storage or reserve samples created*

 

Q - 322: Which of the following is a rule that governs the

maintenance of storage data?  46-1?????

A. Storage date must be subsequent to the date of receipt of

sample*

B. Storage date must not be a future date*

C. Default quantity for a storage condition must be replaced with

an actual quantity*

D. Total sample quantity is greater than 0*

E.

 

Q - 323: Which of the following is an activity required to plan a

stability test?  5-3

A. Define storage conditions for samples*

B. Create physical sample record for sampe*

C. Create test schedule to plan frequency and scope of test*

D. Create inspection plans for stability study*

E. Assign strategy to test plan header*

F. Assign packages to inspection operation*

G. Create test schedule by creating one item for each storage

condition in study*

H. Process test schedule to assign test plan to each staorage

condition in schedule*

I. Complete test schedule*

J. Print storage list for sample*

K. Calculate quantity for samples and storage conditions*

L. Maintain data for samples*

M. Draw samples from material of first sample*

N. Prnt sample labels and atach to samples*

O. Place samples in storage*

P. Define start date of study*

Q. Calculate test dates*

 

Q - 324: Identify a step performed for each sample during the

performance of a stability test. 50

A. Inspection lots for test dates are created using deadline

monitoring*

B. Shop papers are printed for each inspection lot when it is

created*

C. Sample drawing instruction is used to remove samples from

storage conditions and delivered to lab for test*

D. Perform test*

E. Complete stability study*

F. Remove stability samples from storage*

 

Q - 325: Identify a step used to create an inspection plan for a

storage condition when the engineering workbench is used in the

process.  39-1

A. Select a work area*

B. Activate inspection points for physical samples in the plan

header*

C. Assign a strategy to plan header*

D. Specify intervals at which each operation in plan will be

tested*

 

Q - 326: Identify a step in the execution of a stability test

A. Deadline monitoring function is used to create inspection lots

for future test dates*

B. Shop papers accessed for inspection lot when lot created*

C. Remove samples from storage conditions per sample drawing

instruction and deliver to lab for testing*

D. Perform test*

E. Record test results*

F. Return sample to storage*

G. Complete test with usage decision for lot*

H. Repeat for each test in study*

I. Evaluate results of test*

 

Q - 327: Identify an unlanned activity for a stability study. 70-2

A. Add storage conditions for samples*

B. Creat lot for a storage condition*

C. Revise storage condition*

D. Deactivate storage condition*

E. Activate storage condition*

F. Deletion of storage condition*

G. Addition of tests to inspection plan*

H. Addition of test dates to test schedule*

I. Deactivation of stability study*

J. Reactivation of stability study*

 

Q - 328: What is the objective

 

Q - 329: What is the objective

 

Q - 400:  is calculated on the basis of

 

Q - 401: Which of the following is an example of a function

 

Q - 402: Control indicator

 

Q - 403:  is dependent on

 

Q - 404: Why is      used

 

Q - 405: can be changed

 

Q - 406: What is the function of

 

Q - 407: indicator determines

 

Q - 408:   difference

 

Q - 409:    _______, _____________, and _______ are examples of x.

 

Q - 410: What is triggered by x?

 

Q - 411: Which of the following is defined in the IMG

 

Q - 412:  Attributes of x include

 

Q - 413: The x function requires

 

Q - 414: Which of the following is a restriction regarding

 

Q - 415: x determines

 

Q - 416: x is determined by which of the following?

 

Q - 417: If x, which of the following is an example of

 

Q - 418: which of the following can be replaced

 

Q - 419: which of the following cannot be replaced

 

Q - 420: list displays

 

Q - 421: requirement to delete

 

Q - 422: restriction regarding the deletion

 

Q - 423: Which of the following is an example of a function

 

Q - 424: What is the purpose of the x data element

 

Q - 425: What statement is relevant to

 

Q - 426: What procedures exist to

 

Q - 427: determines

 

Q - 428: Where is x specified

 

Q - 429: What determines

 

Q - 430: What determines how

 

Q - 431: How is x determined

 

Q - 432: What determines if

 

Q - 433: What determines the format

 

Q - 434: default values

 

Q - 435: determines what is used

 

Q - 436: determines if x deleted

 

Q - 437: What IMG element

 

Q - 438: Is x data defined for each

 

Q - 439: _________,___________, and _________- is defined

 

Q - 440: For each

 

Q - 441:_______________ can be defined

 

Q - 442: What data element(s) is found in

 

Q - 443: What x data is defined in

 

Q - 444: Which of the following is a true statement regarding

creation

 

Q - 445:  Why are x assigned

 

Q - 446: difference between

 

Q - 447: functions that can be performed using the x transaction

code

 

Q - 448: function that can be performed using the x list

 

Q - 449: purpose of the assignment

 

Q - 450: At the time x, you can

 

Q - 461: The parameters     are defined in

 

Q - 462:    is flagged for         by

 

Q - 463: What is used to determine x for

 

Q - 464: What is a prerequisite

 

Q - 465: What is the result

 

Q - 466: Where is x set

 

Q - 467: is defined at the x level of

 

Q - 468: Data elements that are defined at the x level include

 

Q - 469: What is the function of the x

 

Q - 470: What is the function of the x field

 

Q - 471: What types of

 

Q - 472:______,_______, and _____ are data elements in a

 

Q - 473: ______, ________, and ______ is entered in the definition of

x

 

Q - 474: x function is dependent on x

 

Q - 475: default values are dependent on x

 

Q - 476: the date of x is dependent on

 

Q - 477: the x that is used is dependent on

 

Q - 478: As x, you can

 

Q - 479: What is the effect

 

Q - 480: What is the x date

 

Q - 481: Why is x used

 

Q - 482: is not found

 

Q - 483: function requires

 

Q - 484: x refers to

 

Q - 485: restriction related to

 

Q - 486: Which of the following is a result

 

Q - 487: The purpose of the assignment

 

Q - 488: restriction related to the change

 

Q - 489: x and y data elements determine

 

Q - 490: result of a linkage

  

Q - 491: What controls

 

Q - 492: Which of the following controls x

 

Q - 493: Which of the following pertains to

 

Q - 494: Which of the following is true

 

Q - 495: What is the ffect

 

Q - 496: Which of the following is controlled

 

Q - 497:  x cannot be changed

 

Q - 498: Data elements

 

Q - 499: What enables

 

Q - 500: What activity

 

Q - 501: What is the effect

 

Q - 502: What is the purpose

 

Q - 503: example of functions

 

Q - 504: As x is created, you can

 

Q - 505: is dependent on

 

Q - 506: What is the function

 

Q - 507: ________, ___________, and __ are data elements in

 

Q - 508: ___________, _____, and ___________ is entered during th e

definition of x

 

Q - 509: is dependent on

 

Q - 510: What is the result

 

Q - 511: Where is x set

 

Q - 512: What is used to determine x

 

Q - 513: What is the result

 

Q - 514: What determines

 

Q - 515: is data defined for

 

Q - 516: What is the function of

 

Q - 517: What statement is relevant

 

Q - 518: x,x, and c are examples of what

 

Q - 519: What method

 

Q - 520: Advantage of

 

Q - 521: Which of the following is an example of

 

Q - 522: What is the significant of

 

Q - 523:  The x function can be used

 

Q - 524: A x list can be created for

 

Q - 525: What is the relationship between

 

Q - 526: How is x identified

 

Q - 527: A x is snonomous with y

 

Q - 528: is automatically

 

Q - 529: x date is referenced for what purpose

 

Q - 530: More than on x can be

 

Q - 531: x is an example

 

Q - 532: is dependent on

 

Q - 533: is used in

 

Q - 534: Which of the following describes

 

Q - 535: What is used to specify