FDC Senior Officer QA Interview Questions, Process, and Tips for Experienced

Validation ensures that a product meets specified requirements and functions correctly in its intended environment.

• Define validation criteria based on user needs and regulatory requirements.

• Conduct validation planning, including scope, resources, and timelines.

• Execute validation activities such as testing, inspections, and reviews.

• Document results and ensure traceability to requirements.

• Examples include software valida

The sampling process involves defining the population, selecting a sample, and analyzing data to draw conclusions.

• Define the population: Identify the entire group you want to study, e.g., all patients in a hospital.

• Determine the sample size: Decide how many individuals to include in the sample, e.g., 100 patients.

• Select the sampling method: Choose a technique like random sampling or stratified sampling, e.g., random se...read more

Deviation is a departure from a standard or norm, often in the context of quality assurance.

• Deviation is a variation from an established process or procedure.

• It can be caused by human error, equipment malfunction, or external factors.

• Deviation must be documented, investigated, and corrective actions taken to prevent recurrence.

• Examples include a machine malfunction causing a product defect or a missed step in a manufac

Sampling is the process of selecting a subset of a population to represent the entire group for testing or analysis.

• Determine the population to be sampled

• Choose a sampling method (random, stratified, cluster, etc.)

• Decide on the sample size

• Collect the samples

• Analyze the samples and draw conclusions

AQL sampling is a statistical method used in quality control to determine the acceptable quality level of a product batch.

• AQL stands for Acceptable Quality Level, which is the maximum percentage of defective units that is considered acceptable in a batch of products.

• AQL sampling involves randomly selecting a sample of units from a batch and inspecting them for defects.

• The AQL limits are predetermined values that specif...read more