Parexel International Regulatory Affairs Associate Interview Questions and Answers

IP can refer to intellectual property, internet protocol, or intraperitoneal in medical field.

• Intellectual property (patents, trademarks, copyrights)

• Internet Protocol (IP) addresses for devices on a network

• Intraperitoneal (IP) administration of drugs in medical field

Quality control is a process that ensures products or services meet specified requirements and standards.

• Quality control involves monitoring and testing products or services to identify any defects or deviations from standards.

• It aims to prevent defects or errors from occurring and to ensure consistent quality throughout the production or service delivery process.

• Quality control includes activities such as inspections,...read more

Change control is a process used to manage and document changes to regulated products or systems.

• Change control ensures that changes are properly evaluated, approved, and implemented.

• It helps maintain compliance with regulatory requirements and quality standards.

• Change control involves identifying the need for a change, assessing its impact, and implementing it in a controlled manner.

• Documentation and tracking of chang...read more

Types of packaging include primary, secondary, and tertiary packaging.

• Primary packaging is the immediate container of the product, such as a bottle or blister pack.

• Secondary packaging is used to group primary packages together, like a box or carton.

• Tertiary packaging is used for transportation and storage, such as pallets or shrink wrap.