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Biotechnology disease > Lecture 5A & B > Flashcards

Lecture 5A & B Flashcards

1
Q

What is the 3 main frame of quality management system

A

Pre-examination
examination
Post-examination

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2
Q

What is the optimal path of workflow

A

Procedures:
Processes:
Policies

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3
Q

What is the procedure of the workflow

A

Standard operating

procedures. “How to do it”

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4
Q

What is the process of the workflow

A

carrying out quality
policies to transform inputs into
outputs. “How it happens”

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5
Q

What is the policies of the workflow

A

: documented
statement of overall intentions
and direction of the
organization. “What to do”

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6
Q

What part of the workflow is in the laboratory section manual

A

Procedures

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7
Q

Which part of the workflow is in the quality system manual

A

Processes

Policies:

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8
Q

What does the lab section manual step-by-step protocal ensures

A
  • Consistency (multiple staff)
  • Accuracy (not relying upon memory)
  • Quality (complies with standard)
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9
Q

What is Document Controlled Laboratory Manual

A

making sure all the documents are up to dated
and make sure all things done in the lab are documented

Traceability

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10
Q

What is equipment log and maintenance in lab

A

• Asset register
• Maintenance schedule
• Cleaning roster
• Calibration (e.g. micropipettes every 3 months)
• Metrological traceability:
result can be related to a reference through documented
unbroken chain of calibrations e.g. balance

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11
Q

What is quality assurance

A

• Planned and systematic set of quality activities focused
on providing confidence that quality requirements will
be fulfilled
• Quality assurance panel (QAP), proficiency test
• Quality assurance versus quality control?

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12
Q

What is the Enrolment in Quality Assurance Panels

A
  • Accreditation requirement
  • Education
  • Verify methods & procedures
  • Identify problems
  • Assess performance
  • Comparison with peers
  • Demonstrate competence
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13
Q

What are the few quality management system

A 
Section manual
Biosafety
SOPs
Staff training
Quality system manual
Defined management structure
GLP
Document control
Internal audits
Quality assurance panels
Quality control Method validation
Equipment maintenance
Result recording & reporting
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14
Q

What is gap analysis

A

Implementation of changes required to
improve the system will come from
audits, QAP, management review, quality
indicators (e.g. turnaround time)

Outdated

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15
Q

What is PDCA

A

Plan
Do
Check
Act

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16
Q

What is (ISO

A

• International Organization for Standardization (ISO)
• Standards Australia: development and adoption of
standards in Australia but do not enforce, regulate or
certify compliance with these standards

17
Q

What is the international standard organization the australia use

A

• National Association of Testing Authorities (NATA)
• Established in Australia in 1947, first laboratory
accreditation body
• NATA determines a facility’s technical competence
based on the relevant international standard
• Only endorsed assessing body for pathology
accreditation in Australia

18
Q

What is Laboratory biosafety

A 
containment
principles, technologies, and practices
implemented to prevent unintentional
exposure to pathogens and toxins, or their
unintentional release
19
Q

What is Laboratory biosecurity

A

protection,
control and accountability for valuable
biological materials within laboratories, in
order to prevent their unauthorized
access, loss, theft, misuse, diversion, or
intentional release

20
Q

What are the two categories based on scientific assessment of risk during transportation

A
  • Category A: capable of causing permanent disability, lifethreatening or fatal disease in otherwise healthy humans or animals
    eg. Avian paramyxovirus type 1 – velogenic Newcastle disease virus
  • Category B: does not meet the criteria for inclusion in Category A
    eg. swabs for investigation of equine influenza infection; stool specimens for
    diagnostic testing
21
Q

What SSBA

A

Security Sensitive Biological Agents
• National standards for the handling, storage, disposal and
transport of SSBA and suspected SSBA

22
Q

What are the two tiers of Security Sensitive Biological Agents (SSBA)?

A

• Tier 1 agents pose the highest security risk
e.g. foot-and-mouth disease virus, highly pathogenic influenza virus
infecting humans
• Tier 2 agents pose a high security risk
e.g. sheep pox virus and goat pox virus, Yellow fever virus

23
Q

What is Equine influenza

A 
Outbreak 2007
• Exotic disease in Australia
• Routine vaccination not permitted except for
horses intended for export
• Largest exotic animal disease event in
Australia
24
Q

What is the main detection of equine influenza virus

A

Detection of virus or virus product from nasal swabs

25
Q

What are the type of Diagnostic Laboratory Tests

A
  • Antigen/pathogen detection: ELISA, PCR, EM
  • Serology: single or paired sample
  • Histopathology
  • Culture (tropism)
26
Q

What are the factors on Diagnostic Laboratory Tests

A
  • Specificity including wild vs vaccine
  • Sensitivity
  • Validation
  • Controls
  • Timeliness
27
Q

What is the reservoir for Global Rinderpest

A

• Disease of cloven-hoofed animals, cattle most
important reservoir
• Morbillivirus related to viruses causing peste
des petits ruminants, canine distemper &
measles
• Differential diagnosis includes bovine viral
diarrhea and foot-and-mouth disease

28
Q

What is the AMP model

A

Biorisk Management =
Assessment + Mitigation +
Performance

29
Q

Waht is the likelihood and consequences of risk

A

Likelihood
Factors that affect
whether or not the
incident happens

Consequences
Factors that affect
the severity of the
incident

30
Q

What is the Mitigation: hierarchy of controls

A 
Elimination or Substitution
Engineering Controls
Administrative Controls
Practices and Procedures
Personal Protective Equipment
31
Q

What is the Assessment of biorisk management

A

Risk identification
Hazard/threat identification
Likelihood evaluation
Consequences evaluation

32
Q

What is Mitigation of biorisk management

A 
Elimination or Substitution
Engineering Controls
Administrative Control
Practices and Procedures
Personal Protective Equipment
33
Q

What is the performance of biorisk management

A

Gap analysis

Biotechnology disease (8 decks)

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