Risk Assessment & Management Flashcards
7 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Risk Assessment & Management flashcards as text
In pharmaceutical risk management, what is the primary goal of a Quality Risk Management (QRM) process per ICH Q9?
Answer: To proactively identify, evaluate, and control risks to quality to protect the patient
ICH Q9 states that the primary goal of QRM is to protect the patient by proactively managing risks to product quality throughout the product lifecycle.
A software-based medical device (SaMD) is classified as a Class C (serious injury) device per IEC 62304. Which risk management standard applies specifically to the software lifecycle risks?
Answer: IEC 62304 in conjunction with ISO 14971
IEC 62304 governs the software lifecycle for medical device software and is applied in conjunction with ISO 14971 for risk management of software hazards.
Which element is NOT a required output of the risk management process under ISO 14971?
Answer: Marketing authorization number
ISO 14971 requires a risk management plan, risk management report, and residual risk evaluation, but marketing authorization numbers are regulatory approval outputs, not risk management outputs.
A device manufacturer discovers during PMS that a previously identified risk control is no longer effective. Which action is MOST appropriate?
Answer: Update the risk management file, evaluate the residual risk, and implement revised controls if needed
Post-market findings must feed back into the risk management file; the manufacturer must reassess residual risk and implement revised controls as required by ISO 14971 Clause 10.
In the context of combination products (drug-device), which agency takes the lead review role when the primary mode of action is pharmacological?
Answer: FDA Center for Drug Evaluation and Research (CDER)
When the primary mode of action of a combination product is pharmacological, CDER typically serves as the lead FDA center for review.
What is the significance of the 'probability of harm' distinction in ISO 14971 compared to 'probability of occurrence of a hazardous situation'?
Answer: Probability of harm accounts for both the likelihood of the hazardous situation occurring AND the likelihood that it leads to harm
ISO 14971 separates probability of a hazardous situation from probability of harm—the latter is a compound probability reflecting both exposure and the chance that exposure results in harm.
A regulatory affairs manager is reviewing a risk management plan. Which element confirms the plan complies with ISO 14971 scope requirements?
Answer: Definition of the device, its intended use, and the life cycle phases covered by the plan
ISO 14971 requires the risk management plan to define the device, its intended use, and the scope of risk management activities across the relevant lifecycle phases.