10+ TechNova Imaging Systems Interview Questions and Answers

QA focuses on preventing defects while QC focuses on detecting and correcting defects.

• QA stands for Quality Assurance while QC stands for Quality Control

• QA is a proactive process while QC is a reactive process

• QA focuses on preventing defects while QC focuses on detecting and correcting defects

• QA involves the entire process of product development while QC involves testing the final product

• Examples of QA activities include process mapping, risk assessment, and training while ex...read more

Qualitative analysis involves non-numerical data to understand qualities, while quantitative analysis involves numerical data to measure quantities.

• Qualitative analysis focuses on characteristics, attributes, and qualities of data.

• Quantitative analysis involves the use of numbers and mathematical calculations.

• Qualitative analysis is subjective and exploratory, while quantitative analysis is objective and conclusive.

• Examples of qualitative analysis include content analysis, th...read more

The medical authority of Japan is the Pharmaceuticals and Medical Devices Agency (PMDA).

• The PMDA is responsible for the approval and regulation of pharmaceuticals and medical devices in Japan.

• It was established in 2004 as an independent administrative agency.

• The PMDA works closely with the Ministry of Health, Labour and Welfare (MHLW) to ensure the safety and efficacy of medical products.

• It also collaborates with international regulatory agencies to promote global harmonizati...read more

Certificate of Analysis is a document that provides information on the quality and purity of a product.

• It is a document that accompanies a product and provides information on its quality and purity.

• It includes information on the product's composition, potency, and impurities.

• It is often required by regulatory agencies as part of the product registration process.

• It is typically prepared by the manufacturer or a third-party laboratory.

• Examples of products that may require a Cer...read more

Regulatory affairs involves ensuring compliance with regulations and laws related to products, processes, and services.

• Regulatory affairs specialists ensure that products, processes, and services meet regulatory requirements

• They work with government agencies to obtain necessary approvals and certifications

• They also monitor and report on changes to regulations and laws that may affect their organization

• Examples of regulations they may work with include FDA regulations for medi...read more

In vivo refers to experiments or studies done in living organisms, while in vitro refers to experiments or studies done in a controlled environment outside of a living organism.

• In vivo studies involve testing on living organisms such as animals or humans.

• In vitro studies involve testing in a controlled environment like a test tube or petri dish.

• In vivo studies are more complex and closer to real-life conditions.

• In vitro studies are often used for preliminary testing before mo...read more

Change control process involves documenting, evaluating, and implementing changes to regulated products or processes.

• Document all proposed changes

• Evaluate potential impact on quality, safety, and efficacy

• Implement changes only after approval from relevant stakeholders

• Maintain detailed records of all changes and approvals

Assay is a test used to measure the presence or quantity of a substance in a sample.

• Assays can be qualitative (presence/absence) or quantitative (amount)

• Types of assays include ELISA, PCR, Western blot, and bioassays

• Assays are commonly used in research, diagnostics, and quality control

Melting point is the temperature at which a solid substance changes into a liquid state.

• Melting point is a physical property of a substance.

• It is the temperature at which the solid and liquid phases of a substance are in equilibrium.

• Different substances have different melting points.

• For example, the melting point of water is 0 degrees Celsius.

• Melting point can be affected by pressure and impurities.

Boiling point is the temperature at which a liquid turns into vapor.

• Boiling point is specific to each substance and can be affected by factors like pressure.

• It is the temperature at which the vapor pressure of the liquid equals the atmospheric pressure.

• Water boils at 100 degrees Celsius at sea level.

• Boiling point can be used to identify and characterize substances.