Associate Quality Assurance Interview Questions and Answers

Adverse events are any undesirable experience associated with the use of a drug. Serious adverse events are those that result in death, hospitalization, disability, or birth defects.

• Adverse events can include side effects, but not all side effects are adverse events.

• Side effects are any unintended effect of a drug, whether it is beneficial or not.

• Examples of adverse events include allergic reactions, liver damage, and heart attacks.

• Examples of side effects include drowsiness,...read more

To determine the number of classes required for a page with 5 tabs, each containing common elements and varying numbers of total elements.

• Identify the common elements shared by all tabs on the page.

• Calculate the total number of unique elements on the page.

• Determine the number of classes needed based on the total number of unique elements.

• Consider the possibility of multiple classes for tabs with a higher number of elements.

6 degrees of freedom in CMM refers to the ability to move in 6 different directions, CMM accuracy is the ability to measure accurately, and CMM least count is the smallest measurement that can be displayed.

• 6 degrees of freedom in CMM allows movement in X, Y, Z axes as well as rotation around these axes

• CMM accuracy is determined by factors like machine calibration, environmental conditions, and part fixturing

• CMM least count is the smallest increment that can be measured by the...read more

Dechallenge and rechallenge are important steps in drug trials to determine the causality of adverse events.

• Dechallenge is the process of stopping the administration of a drug to see if the adverse event resolves.

• Rechallenge is the process of reintroducing the drug to see if the adverse event reoccurs.

• These steps help determine if the adverse event is caused by the drug or if it is coincidental.

• Dechallenge and rechallenge are important in determining the safety and efficacy o...read more

Hierarchy of pharma covigilance refers to the levels of responsibility and authority in ensuring drug safety.

• The highest level is the regulatory authority, such as the FDA or EMA

• Pharmaceutical companies have their own internal pharmacovigilance departments

• Healthcare professionals and patients also play a role in reporting adverse events

• The hierarchy ensures that drug safety is monitored and maintained at all levels

Clinical trials have four phases to test the safety and efficacy of a new drug or treatment.

• Phase 1: Small group of healthy volunteers to test safety and dosage

• Phase 2: Larger group of patients to test efficacy and side effects

• Phase 3: Even larger group of patients to confirm efficacy and monitor side effects

• Phase 4: Post-marketing surveillance to monitor long-term safety and effectiveness