50+ Bharat Ram Global School Interview Questions and Answers

Analgesic drugs are pain relievers that work by blocking pain signals to the brain.

• Analgesic drugs are used to relieve pain.

• They work by blocking pain signals to the brain.

• Examples include aspirin, ibuprofen, and acetaminophen.

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

ADR refers to adverse drug reactions while AE refers to adverse events. ADR is specific to drugs while AE is a broader term.

• ADR is a reaction caused by a drug while AE can be caused by any medical intervention or procedure.

• ADR is a known and expected side effect of a drug while AE can be unexpected and not necessarily related to the intervention.

• ADR is reported to regulatory authorities while AE can be reported to any healthcare provider.

• Examples of ADR include nausea, vomiti...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

Clinical trials typically have four phases.

• Phase 1: Small group of healthy volunteers to test safety and dosage

• Phase 2: Larger group to test effectiveness and side effects

• Phase 3: Even larger group to confirm effectiveness and monitor side effects

• Phase 4: Post-marketing studies to monitor long-term effects and compare to other treatments

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

I handle changing requirements by prioritizing them based on impact and feasibility.

• Regular communication with stakeholders to understand the changes

• Prioritizing changes based on impact and feasibility

• Adapting the project plan and timeline accordingly

• Implementing Agile methodologies to accommodate changes

• Ensuring clear documentation of changes for team members

I know Python, R, SQL, and Java.

• Python

• R

• SQL

• Java

PV is important for identifying and managing potential risks in various industries.

• PV stands for pharmacovigilance, which is crucial in the pharmaceutical industry for monitoring the safety of drugs.

• PV is also important in other industries such as aviation, where it helps identify potential safety hazards and prevent accidents.

• PV involves collecting, analyzing, and evaluating data on adverse events and taking appropriate measures to minimize risks.

• Effective PV can improve pub...read more

Causality refers to the relationship between an event (the cause) and a second event (the effect), where the second event is a result of the first.

• Causality is the principle that everything has a cause and effect.

• It is the relationship between an action and its consequences.

• Causality can be used to determine the root cause of an accident or incident.

• Examples of causality include smoking causing lung cancer, or lack of sleep causing fatigue.

• Causality is important in safety sci...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

Medra is a medical dictionary used for coding adverse events and medication errors in clinical trials and post-marketing surveillance.

• Medra stands for Medical Dictionary for Regulatory Activities

• It is a standardized medical terminology used for coding adverse events and medication errors in clinical trials and post-marketing surveillance

• It is maintained by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

• It includes ...read more

ICH stands for International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.

• ICH is a global organization that develops guidelines for the pharmaceutical industry.

• It aims to promote the safety, efficacy, and quality of pharmaceutical products.

• ICH guidelines cover various aspects of drug development, including clinical trials, manufacturing, and registration.

• Examples of ICH guidelines include the Common Technical Document (CTD) and Good Cl...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

Calculate average age of male and female and list below average age.

• Separate male and female ages into two arrays

• Calculate average of each array

• List out ages below the average for each array

PV stands for Process Validation.

• PV is a documented evidence that a process consistently produces a product meeting its predetermined specifications and quality attributes.

• It involves establishing scientific evidence that a process is capable of consistently delivering quality products.

• PV is an important aspect of quality assurance and is required by regulatory agencies in industries such as pharmaceuticals and medical devices.

• Examples of PV include testing the sterilization ...read more

I prioritize backlog based on value, dependencies, deadlines, and customer feedback.

• Prioritize user stories with high business value

• Consider dependencies between user stories

• Meet deadlines by prioritizing critical tasks first

• Incorporate customer feedback to adjust priorities

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Pharmacovigilance is the process of monitoring and evaluating the safety of drugs.

• It involves the collection, analysis, and reporting of adverse drug reactions (ADRs) and other drug-related problems.

• Pharmacovigilance aims to improve patient safety by identifying and minimizing the risks associated with the us...read more

Team development parameters include communication, skill development, goal setting, and feedback.

• Regular team meetings to discuss progress and challenges

• Individual development plans to identify skill gaps and training needs

• Setting SMART goals to track progress and measure success

• Providing regular feedback and recognition for achievements

• Encouraging open communication and collaboration within the team

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

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Pharmacovigilance is concerned with the safety of drugs and medicines.

• It involves monitoring and reporting adverse drug reactions (ADRs) and other drug-related problems.

• Pharmacovigilance activities include collecting and analyzing data on drug safety, evaluating the risks and benefits of drugs, and communicat...read more

Adverse reactions are unwanted effects of drugs that occur at normal doses. Adverse effects are harmful effects of drugs.

• Adverse reactions are usually predictable and dose-dependent.

• Adverse effects can be caused by overdose, drug interactions, or idiosyncratic reactions.

• Examples of adverse reactions include nausea, headache, and dizziness.

• Examples of adverse effects include liver damage, kidney damage, and allergic reactions.

• Pharmacovigilance is the process of monitoring and ...read more

DTYPE and PARAMTYPE are data types used in statistical programming.

• DTYPE stands for Data Type and refers to the type of data being used in statistical programming.

• PARAMTYPE stands for Parameter Type and refers to the type of parameter being used in statistical programming.

• Examples: DTYPE can be numeric, character, or date. PARAMTYPE can be input, output, or inout.

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

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

• Pharmacovigilance involves monitoring and evaluating the safety of drugs.

• It aims to identify and prevent adverse drug reactions (ADRs) and adverse events (AEs).

• ADRs are unwanted or harmful reactions caused by the use of a medication.

• AEs are any untoward medical occurrences associated with the use of a drug, w...read more

Expected CTC refers to the salary range that the candidate is expecting for the position.

• Expected CTC is the salary range that the candidate is looking to receive for the job.

• It is important for the employer to know the candidate's salary expectations to ensure they are aligned with the company's budget.

• Candidates should research industry standards and their own experience to determine a reasonable Expected CTC.

• Candidates can negotiate their Expected CTC during the job offer ...read more

User stories are short, simple descriptions of a feature told from the perspective of the person who desires the new capability.

• As a user, I want to be able to create a profile so I can personalize my experience

• As a user, I want to be able to search for products by category so I can easily find what I need

• As a user, I want to be able to add items to my shopping cart and checkout quickly

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.

Frequency counts can be obtained by counting the number of occurrences of each unique value in a dataset.

• Use the COUNTIF function in Excel to count occurrences of a specific value in a column

• Use the value_counts() function in Python's pandas library to get frequency counts of unique values in a dataframe column

• Use the table() function in R to get frequency counts of unique values in a vector or dataframe column

ICH GCP Guidelines are international standards for designing, conducting, recording, and reporting clinical trials.

• ICH GCP Guidelines ensure the safety, rights, and well-being of trial subjects.

• They also ensure the credibility and accuracy of trial data.

• Adherence to ICH GCP Guidelines is mandatory for conducting clinical trials in many countries.

• Examples of ICH GCP Guidelines include requirements for informed consent, data integrity, and investigator qualifications.

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, sampling, testing, and documentation.

• It may involve the u...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 changes are essential parts of the change control process.

• Examp...read more

Real World Evidence is data collected from real-world settings to evaluate the safety and effectiveness of medical treatments.

• Real World Evidence is collected from sources such as electronic health records, claims data, and patient-generated data.

• It is used to complement data from clinical trials and provide a more complete picture of a treatment's safety and effectiveness.

• Real World Evidence can be used to inform regulatory decisions, clinical guidelines, and healthcare poli...read more

The Rave process is a comprehensive validation process used to ensure accuracy and reliability of data.

• The Rave process involves multiple steps such as data entry, data cleaning, data validation, and data analysis.

• Data entry involves entering the collected data into a database or system.

• Data cleaning involves reviewing and correcting any errors or inconsistencies in the data.

• Data validation involves verifying the accuracy and completeness of the data.

• Data analysis involves an...read more

The day to day activities of a Validation Associate involve conducting validation tests, analyzing data, documenting results, and collaborating with cross-functional teams.

• Conducting validation tests on equipment, processes, and systems

• Analyzing data and interpreting results to ensure compliance with regulations and standards

• Documenting validation activities, including test protocols, reports, and standard operating procedures

• Collaborating with cross-functional teams, such as...read more

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

New changes in CT rules affect clinical research

• New CT rules require more transparency in clinical trial data

• Changes include mandatory registration of clinical trials and reporting of results

• CT rules also require informed consent from trial participants

• These changes aim to improve patient safety and ensure reliable data for drug approvals

GCP stands for Good Clinical Practice, a set of international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials.

• GCP ensures the safety and well-being of trial participants

• GCP ensures the credibility and accuracy of trial data

• GCP is mandatory for all clinical trials involving human subjects

• GCP guidelines cover various aspects of clinical trial conduct, including trial design, informed consent, data management, and moni...read more

ALS SPEC TABS DETAILS

• ALS refers to Amyotrophic Lateral Sclerosis, a progressive neurodegenerative disease

• SPEC stands for Speech Generating Device, which helps individuals with communication difficulties

• TABs are communication software applications installed on SPEC devices

• ALS SPEC TABs DETAILS may refer to the specific features, functions, or options available in the TABs for ALS patients