Fortrea Development India Private Limited Junior Regulatory Affairs Specialist Interview Questions and Answers

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.

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

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.

• Exa...read more