Senior Executive Quality Control Interview Questions and Answers

Computer systems used in the medical field must be compliant with 21 CFR part 11.

• Electronic medical record systems

• Laboratory information management systems

• Pharmacy management systems

• Clinical trial management systems

• Medical device software

• Electronic data capture systems

Both 21 CFR part 11 and EU Annex 11 are equally precise for computer system.

• Both regulations provide specific guidelines for electronic records and signatures.

• 21 CFR part 11 applies to FDA-regulated industries in the US, while EU Annex 11 applies to pharmaceutical companies operating in the EU.

• Both regulations require validation of computer systems and controls to ensure data integrity and security.

• EU Annex 11 places more emphasis on risk management and data privacy.

• Complianc...read more

Handling customers and internal communications in NC involves clear communication channels and timely responses.

• Establish clear communication channels for customers and internal teams

• Ensure timely responses to customer inquiries and feedback

• Implement regular updates and feedback mechanisms to keep stakeholders informed

• Train staff on effective communication strategies and customer service best practices

Toilet soap is used for personal hygiene while laundry soap is used for washing clothes.

• Toilet soap is formulated with ingredients that are gentle on the skin.

• Laundry soap is designed to remove tough stains and dirt from clothes.

• Toilet soap comes in various forms such as bars, liquid, and foam.

• Laundry soap is available in powder, liquid, and bar forms.

• Toilet soap may contain moisturizing agents like glycerin and shea butter.

• Laundry soap may contain enzymes and surfactants to ...read more

8D Analysis is a problem-solving methodology used to identify, correct, and prevent recurring problems.

• 8D stands for 8 disciplines, each representing a step in the problem-solving process.

• It involves identifying the problem, forming a team, implementing temporary and permanent corrective actions, and preventing recurrence.

• Examples of tools used in 8D Analysis include fishbone diagrams, Pareto charts, and root cause analysis.

Alcoa+ is a quality improvement program developed by Alcoa to enhance productivity and safety.

• Alcoa+ focuses on continuous improvement in quality, safety, and productivity.

• It involves a structured approach to problem-solving and decision-making.

• Alcoa+ has been successful in reducing costs, improving efficiency, and increasing customer satisfaction.

• Examples of Alcoa+ initiatives include employee training programs, process improvements, and data analysis.

• The program has been ad...read more

ICH guideline provides recommendations for conducting stability studies on pharmaceutical products.

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

• The guideline outlines the minimum requirements for conducting stability studies on drug substances and drug products

• It includes recommendations on the design, testing conditions, and evaluation of stability data

• Stability studies are conducted to determine the shelf ...read more

HPLC principle stands for High Performance Liquid Chromatography, a technique used to separate, identify, and quantify components in a mixture.

• HPLC involves the use of a liquid mobile phase and a solid stationary phase to separate components based on their interactions with the phases.

• It is a widely used analytical technique in various industries such as pharmaceuticals, food and beverage, environmental analysis, and more.

• HPLC can be used to analyze complex mixtures, such as ...read more