What is Dress Code for Interview???

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Dress Code for Interview

Believe it or not, you are examined from head to toe in all interviews. Not only is your experience and personality sized up…but also your appearance.

The purpose of your clothing is to project an image of professionalism. Deciding what to wear to an interview is often a stressful part of the preparation process.

Successful job interviews depend on both how well you answer questions and how you present yourself.

That’s why a smart, pulled together appearance can help convince the hiring manager that you’re a great fit for the company.

Many people take for granted the appearance aspect of the job hunting process. The better you are dressed, the more confident you will feel and exude.

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Dress Code for Men:

1) Shirts:

Wear collared shirts with long sleeves

Wear single color shirts. Stripes on shirts look good, but they shouldn’t be too bold or too thin and too close to each other.

Wear a light-colored, pressed button-down shirt with long sleeves and a collar, and make sure it’s neatly tucked into your pants.

You can wear a knit tie with a simple pattern or solid color, but this is completely optional.

It’s also appropriate to layer a nice sweater over a button-down shirt for a polished business casual look. Although it’s not mandatory, consider throwing on a grey, black or navy blue blazer or lightweight sports jacket for a more pulled together outfit.

Avoid wearing a polo shirt even if you’re interviewing at a laid-back company.

2) Trousers:

The length of the trousers should be just right; it should fall well and not bunch up at the bottom.

Tapering trousers are in vogue, but make sure that it doesn’t taper to the extent of hugging your calves and ankles.

Crisply pressed cotton trousers, light-colored chinos or khakis are great options for a business casual interview.

Avoid self-print or striped trousers. Stick to neutral colors like grey, black, brown and navy blue, since these match many shirt colors.

In some workplaces, it may be acceptable to wear dark colored jeans. If you’re not sure if jeans are appropriate in this office, wear trousers instead.

3) Tie:

A double-knot tie is the right size to wear. A larger tie knot can give you a more confident look while a symmetric one looks elegant.

Choose a tie knot that fits the collar opening of the shirt. For example, a small tie knot like the four-in-hand suits shirts with a narrow collar opening, while a large tie knot like the Windsor suits shirts with a wide collar opening.

As for the ideal length of your tie, the tip of the wider end should be at the same level as your belt.

And be wise in deciding the color of the ties. Ties with dark colors are preferred.

4) Dark shoes with matching socks:

Gentlemen, if you are wearing a black belt then match it with black shoes, a brown belt with brown shoes.

Choose dark-colored, freshly-polished leather shoes. You can wear brown or black loafers, lace-up dress shoes, Oxfords or another professional closed-toe shoe that compliments your outfit.

Shoes should be polished; and no pointed, long shoes. Be sure to wear mid-calf length dress socks that match the color of your trousers. Avoid athletic socks.

Recruiting companies say it’s a good idea to match the shoes or the belts with the color of the spectacles, handbags or briefcases. So keep that in mind, as well.

5) Simple Accents:

You may choose to wear a classic wristwatch with a metal or leather band, but you should remove any distracting jewelry, such as earrings, necklaces or bracelets.

Always wear a leather belt that closely matches your shoe color. You could add a simple pocket square to a blazer pocket to complete the look.

6) Hair-say:

Nothing looks neater than a short haircut in men. Gel your hair to avoid any stray hair sticking out, but do not overdo it or back comb your hair as it will send out a wrong message.

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Dress Code for Women:

1) Simple, professional tops:

While Salwar-suits do look elegant, managing the stole can be a task, unless it’s of a material that stays and you don’t have to keep adjusting it in its place.

A kurti and salwar is, in fact, a better option. Since there’s no stole with it, with the right pattern and color, it can look formal and business-like. But no heavy sequins or embroidery!

Wear a top that is comfortable, professional and conservative. Try a button-down shirt paired with a cardigan, a simple blouse with a casual jacket, a navy blue blazer or a knit sweater.

Choose neutral colors and simple patterns. Avoid slouchy or oversized sweaters, ill-fitting clothes, plunging necklines and fabric that wrinkle easily. It’s also an option to wear a casual dress paired with a cardigan and simple belt.

2) Dress Pants or a Skirt:

Pair your top with black or navy slacks or a pencil skirt (knee length or longer) that have been ironed.

If you’re wearing a button-down shirt, you may want to tuck it into your pants or skirt for a polished look. It’s also acceptable to wear khaki or cotton pants, as long as they look professional.

3) Comfortable, Closed-toe shoes:

For your business casual interview, wear black or brown closed-toe flats, pumps or low heels.

No fancy heels, stilettos, and bright colors. Make sure your shoes are not scuffed, scratched or dirty, and avoid strappy sandals, flip-flops, sky-high stilettos, sneakers or brightly colored shoes.

4) Simple accessories:

Keep your jewelry choices simple and professional. Traditional nose pins are acceptable, provided they are small and pretty.

Don’t wear any gaudy stuff. As for necklaces and earrings, small is beautiful and smart. Avoid chunky, large or distracting bracelets, necklaces and earrings.

Instead, wear simple hoop or stud earrings, a delicate necklace and one or two simple bracelets that don’t jangle.

If you wear nail polish, make sure it’s unchipped and in a classic, muted color.

5) Hair say:

Women could wear their hair in a bun, neatly held in pins or a plain black scrunch. A high, top bun will look right for the aviation sector.

If you wish to wear your hair open, then blow-dry and set it. When you comb or brush your hair, please brush the stray strands off your shirts or tops.

In case there’s a dandruff problem, take care of it; white skin flakes on a dark suit is not a good idea.

As for bulging pockets, body-piercing, tattoos, low-waist trousers and male jewelry common sense would say: avoid it, please. One gem stone ring is fine; too many might show you in a different light.

Final Step: Do a dress rehearsal

Try on your complete outfit a few days ahead of the interview to ensure everything fits properly and looks clean and professional. Do a mock interview with a friend or family member while wearing your interview outfit to see how it fits and feels. The night before, check one last time for any wrinkles, stains, holes or pet hair.

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  • Trick to Improve Communication Skill
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Interview & its Types

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“Luck is what happens when preparation meets opportunity.” By Seneca, Philosopher


What is interview?

The word interview comes from Latin and middle French words meaning to “see between” or “see each other”.

Generally, an interview means a private meeting between people when questions are asked and answered.

When you split the word ‘interview’ you get two words, ‘inter’ and ‘view’. This roughly translates to ‘between view’ or seeing each other.

An Interview is a formal consultation or meeting for the purpose of ascertaining and evaluating the qualifications of a person, group of people, or company to fill a particular job situation.

The person who answers the questions of an interview is called in the interviewee. The person who asks the questions of an interview is called an interviewer.

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Types of Interviews:

There are many types of interviews that an organization can arrange. It depends on the objectives of taking the interview.

An interview can be broadly seen as a formal meeting arranged to evaluate a prospective employee by obtaining his/her career-oriented details, like qualification and work-experience.

An interview presents the applicants an opportunity to elaborate on certain components of their CV and talk about their areas of expertise. It also tests their ability to think critically and independently.

Depending on the position and the company you are getting hired for, you might need to appear in various types of interviews.

1. Personal Interview (One-to-One Interview):

It is the most common among the interview types; it involves the interviewer asking questions maybe both technical and general to the interviewee to investigate how fit the candidate is for the job.

There are only two participants — the interviewer (usually the representative of the company) and interviewee. It’s a simple question and answer session, in order to transfer information.

Personal interview is designed to obtain information through discussion and observation about how well the interviewer will perform on the job.

Personal Interviews include:

  • Selection of the Employees
  • Promotion of the Employees
  • Retirement and Resignation of the Employees

2 Formal Interview (structured interview):

It is held in formal atmosphere with Pre-decided and planned procedures and questions.

Here in the traditional form of an interview, the questions asked are all in a standard format and the same is used for all the candidates.

It is also known as a patterned or guided interview.

Example: Entry level Jobs for Fresher.

3 Informal Interview (unstructured interview):

This is the opposite of a informal interview. There is no specific procedure followed in this case.

They are conducted at any place, and any types of questions can be asked to the candidate.

The discussion is free flowing, and questions are made up during the interview.

The interviewer may deviate and a conversation type interview follows.

Example: Mid-level job interview for managerial position

4 Stress Interview:

Stress Interview is very rare, but such interviews are conducted to see how the candidate will be able to react in stressful situations and to assess if he will be able to handle the crisis at his job.

The employer uses stress interview for those jobs which are more stress prone.

It is conducted to evaluate the behavior of the candidate under stressful conditions.

A number of harsh, rapid fire questions are put to the interviewee with intent to upset him & Verifies whether candidate remains quiet and calm or becomes stressed.

It indicates their stress-handling capacity in future.

Some tactics involved include:

  • Completely ignore the candidate by maybe, making a phone call in the middle of the interview.
  • Or some other tactic like continuously interrupting the candidate when he answers the questions.
  • Trying to enforce your point of view forcefully even if he disagrees.
  • Asking a whole lot of questions all at once.
  • Interrupting him by asking another question not related to his answer.

5 Situation Interview:

An imaginary situation is told to the candidates and they are asked to respond to it.

Directive Interview:

It is structured interview. A same set of questions is repeated for every candidate to make the comparison among the answers received from them.

Non-directive Interview:

It is non-structured interview. There is no specific format, and any questions can be asked to candidates. Candidates are free to express themselves under this type.

6 Panel Interview:

A selection committee appointed for interviewing candidates is called a panel.

The interviewers here are a group from among the company representatives who are in a senior position.

It generally consists of three or more members who collectively perform the task of selection.

The final decision is taken with the consent of all panel members.

7 Group Interview:

Candidates are supposed to form groups, and one group together will be interviewed at one time.

This involves multiple candidates and they are given a topic for discussion. It is a sort of group discussion.

The person’s ability to lead, their presence of mind, conversational ability and how satisfactorily they are able to have their own views and make others believe in them can be evaluated under this technique.

Here, the best among the lot gets selected.

8 Depth Interview:

When you need to ascertain everything about the interviewee right from life history, academic qualifications, work experiences, hobbies, and interests; you conduct the depth interview.

All the minute details of important nature are asked to a candidate to have the extensive information about them.

Interviewer has a clear idea about the questions he will be asking but once the question is asked, he allows the conversation to flow and is more of a listener.

This interview takes time and more of a friendly approach of the interviewer towards the interviewee.

9 Behavioral-based Interview:

Many companies increasingly rely on behavior interviews since they use your previous behavior which helps interviewer to understand the candidate’s future performance based on his past

The interviewee is asked questions that required problem-solving skills, past work experiences, adaptability, leadership, conflict resolution, multi-tasking & initiative or stress management.

You will be asked how you dealt with the situations. The probing maybe in detail to assess the candidate’s behavior and responses and this determines the candidate’s future job prospects.

Example: Interview for managerial positions, executive posts.

10 Problem-solving Interview (Task Oriented Interview):

Here the interviewer is more concerned about the problem-solving abilities be it technical, managerial, creative or analytical skills.

This is the most common among the interview patterns and it may involve either writing and answering a questionnaire set or answering the technical questions orally.

Example: Interviews for Software recruitment, technical industries, and managerial positions.

11 Competency Interview:

This type of interview focuses on your work-related skills and abilities rather than questions about your personality.

These are structured to reflect the competencies the employer is seeking for the particular job.

This is most advanced interview type. Candidate will be tested on different situations e.g. ‘tell me about a time when you showed good teamwork’.

Prepare by reading the job ad carefully as the core skills mentioned usually make up the questions asked.

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Based on the Facilities or Settings

1 Telephonic Interview:

Instead of inviting a large army of candidates to battle it out in the interview room, many employers use a telephone interview as a quick and cost-effective way to whittle down candidates in the first round.

This is done in the initial stages and before the personal interview. Also when the candidate is far-off.

Company first conducts a telephonic interview and if satisfied then arranges the travel expenses for a one-to-one interview.

This interview is conducted over the phone and its main objective is to narrow down the probable list of candidates so that only the most eligible ones finally get shortlisted.

An advantage to being interviewed over the phone is that you can easily refer to notes that remind you of key points to include.

A disadvantage is that you will not be able to receive or convey non-verbal cues. It is the most economical and less time consuming, which focuses on asking and answering questions.

2 Online Interview:

This interview may be was done by instant messaging, online chats, email or through videos.

Video interview are growing in popularity with the growth of Skype. You may be invited to an office or asked to connect at home using your own computer.

It is more convenient for the interviewer that he can fix the interview at his spare time and convey the message to the candidate a few hours before or so.

Sometimes video interviews are done by agencies, using questions set by the company (managers can then see each candidate answering the same questions and can compare responses).

Due to its flexibility, rapidity and inexpensiveness, it is used increasingly.

3. Job Fair Interview (Career Fair Interview):

Most selection procedures for fresher involve an initial screening stage and a second interview stage.

Interviews are usually conducted by one interviewer. Questions are usually based around key selection criteria.

Then basic technical questions are asked to know if the candidate can proceed further for the main interview. This is a very short interview to net only the potential candidates.

The interviewer also provides information about the organization, its operations and goals, and opportunities available for graduates.

4. Lunch Interview:

This interview is more of a conversational interview mainly designed so that the interviewer gets to know more about the candidate.

At a lunch interview, an employer can afford to take more time and relax some while questioning a candidate.

Interview conducted in a restaurant to assess how well you handle yourself in social situations.

Lunch interview is an entirely different ball game for both the interviewer and the interviewee.

This also helps the interviewer to assess how the candidate conducts himself in a less-formal environment and how he presents himself.

5. Tea Interview:

This is the same as a lunch interview but only that it differs in the time limit. Here the interviewee gets less time to prove himself.

The interviewer here has a structured format for questioning since there is a time limit.

Example: Interview for positions in the fashion and glamour industry and sales posts.

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Importance of Mock Inspection & its Benefits

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Introduction of Mock Inspection

MHRA has said, “QA should also review a sample of relevant audit trails, raw data and metadata as part of self- inspection to ensure ongoing compliance with the data governance policy/procedures.”

According to PIC/S, “The effectiveness of data integrity control measures should be assessed periodically as part of self-inspection (internal audit) or other periodic review processes. This should ensure that controls over the data life cycle are operating as intended.”

A continuous self-inspection program is an important element of overall data integrity governance. Aside from the standard data verification checks built into normal controls, organizations should incorporate a wider range of measures: training checks, consistency and risk-based sample checks, and quality metric tracking.

Mock Inspection is an essential tool in identifying issues that could affect the quality of manufactured pharmaceuticals or medical devices, and become compliance issues with FDA.

Mock inspections are simulations of actual FDA audits conducted to assess Good Clinical Practice, Good Laboratory Practices, and Good Manufacturing Practices.

They can be performed by:

  • An Internal team using FDA procedures, or
  • An External team of ex-FDA employees

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An internal team consists of qualified professionals with experience in regulatory compliance. If an external team is used, it generally consists of members of an outside consulting firm with FDA work experience.

 Mock audits can help pharmaceutical and medical device executives do three things:

1. Determine what FDA inspectors are looking for during an actual audit

2. Preparation for an actual FDA audit

3. Identify common issues of compliance and learn how to rectify them

Why Inspection

The inspection programs cover the gamut of pharmaceutical organizations including but not limited to clinical investigators, sponsors and monitors, contract research organizations (CROs), laboratories, and institutional review boards.

 Although the rules and regulations seem complex, it helps to remember that all inspections are designed to answer a few key questions.

  • Is the organization knowledgeable of, and adhering to, the federal laws and regulations governing clinical trials?
  • Are the safety, rights, and welfare of trial subjects being protected?
  • Can the validity of the clinical data supporting a New Drug Application (NDA) or Biologic License Application (BLA) be confirmed?
  • Was the targeted study well controlled and conducted according to applicable protocols, standard operating procedures (SOPs), and regulations and guidelines?
  • Is complete documentation available to support all of the organization’s training, monitoring, and compliance programs?

When investigators inspect a facility, they expect the organization to be able to supply timely and complete answers in support of these basic questions.

Accomplishing that task quickly and efficiently, however, requires planning and practice. The time to begin preparing for inspections is not the day your organization receives Notice of Inspection.

By designing and implementing a training program for inspections in advance, you will better prepare your organization to meet the demands of any inspection.

The benefits of Mock Inspections

Mock inspections are a good way for your organization to provide a training experience that approximates the intensity of a real inspection.

In essence, a mock FDA inspection is a role-play that casts an individual in the role of an FDA investigator who conducts an inspection “in character” and helps the organization live through a simulated FDA inspection.

 This type of experience is valuable for a number of reasons. It allows you to test your “inspections SOP” under realistic conditions and to determine whether it covers the process completely and provides the guidance people need to respond to the situation quickly and appropriately.

 It also gives you the opportunity to analyze your logistic capabilities, corporate procedures, and information systems to determine whether they can handle the documentation and data demands of an inspection in a timely fashion. As a result, you can identify and correct weaknesses and can enhance your systems and procedures before their shortcomings inflict damage on your organization.

Another important benefit of mock inspections is their ability to make the inspection process more real to those who have never participated in one. With the experience of mock inspections, your employees will have a much better idea about the types of questions they might be asked, what role they should play, and how they should react in various situations.

The primary goal of a mock inspection is to identify gaps prior to an actual inspection.

Below, some tips to proceed in the right direction:

1) Put the right people in the right roles

2) Appropriately prepare your team and documentation

3) Follow the industry standard inspection process

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Traits (Qualities) on which Interviewee will be judged

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Traits on which Interviewee will be judged

An employee is considered the biggest asset of any organization, having the power to manage other assets of the company in the most efficient manner.

Looking for the right job candidate can be difficult, but it doesn’t always have to be. The success of the interview largely depends on the traits and qualities of the interviewee.

Many companies are now focusing on evaluating the personality traits and potential culture fit of candidates in order to find the individual most suited for the job and environment.

The traits are seeking may be determined by the role interviewer are trying to fill, the company they work for, the industry they’re in – or just personal preference.

Interviewers also ask questions about their lifestyle, hobbies, skills, social media presence, and whether they can easily adapt to changes in technology.

Interviewer use targeted interview questions and techniques that help them uncover who the candidates really are instead of just what they can do.

By focusing on a candidate’s personality, companies can find someone who can ‘fit in’ with the organization, which is a win-win for both parties.

1) Personal Characteristics: Do you have good grooming? Do you have good manners? Do you maintain good eye contact?

2) Self-Expression: Are you confident in expressing your ideas?

3) Personality: Questions based on personality traits are commonly asked in interviews and hold a major portion of questions in interviews.

What are you like? Outgoing? Shy? Overbearing? Quiet? Will you fit into their corporate culture?

The interview panel attempts to gauge your ability to answer in a coherent manner.

Your answers also reflect your clarity of mind, self-awareness, strong and weak points of your personality.

You need to answer these questions in an optimistic and confident tone to make a good first impression on the panel.

4) Emotionally Intelligent:

Apart from evaluating the professional competency of a potential employee, interviewers are always on the lookout for people who will add value to the team by a high level of Emotional Intelligence (EQ).

EQ isn’t taught in school, yet it’s so valued today.

It implies that the employee will be able to work successfully in a team, can properly channelize the negative emotions arising due to various reasons and will show a high level of maturity in every situation.

5) Correct Professional Image:

The appearance of a candidate is a powerful feature that defines their personality. It is always necessary to create the right impression by dressing appropriately and observing professional etiquette.

This can be a make or break factor in the interview, where a professionally dressed candidate has better chances of being viewed favorably than a candidate with casual clothing and attitude.

6) Intellectually Curious:

If you have intellectual curiosity, then you’re always looking to learn and better yourself

A very appealing trait because it suggests you is not satisfied with the status quo.

  • Experience. What about your academic achievements? Involvement in extracurricular activities? Job skills?
  • Enthusiasm and Interest. Are you really interested in the employer? The particular job? Industry?
  • Clarity of Goals:

The interview panel intends to probe you on your short-term and long-term career goals.

Questions based on your career objectives are frequently asked in interviews.

What do you want to do in your professional life? Is it consistent with the company goals?

Your answers are evaluated for your suitability to the institute. You need to answer these questions in a manner that links your academic background and interests to your career goals.

7) Stress Management:

While every candidate vouches for the hard work done by him/her, it is rare to find employees who can keep their calm during high-stress situations.

Handling stress efficiently is undoubtedly a good quality, which has a direct impact on the performance of the employee.

Interviewers are always looking for people who will be able to contribute as much during conditions of stress as they do at other times.

8) Subject Knowledge:

This is another crucial area in which the candidate is assessed for his learned skills and abilities.

You should be prepared to answer the fundamental questions related to your academic areas.

The interview panel frequently poses questions from your favorite subjects in order to check your honesty.

Your answers are generally evaluated in terms of the following:

  • Conceptual Clarity
  • Ability to draw from examples

9) Communication Skills:

It is essential to use appropriate and effective language to ace your personal interview.

You need to be brief and precise while answering the questions. The way you answer is as much important as what you answer.

Also, you need to be a good and active listener to answer the questions well.

Your communication skills are checked on the basis of following parameters:

  • Ability to express your views and opinions
  • Command over language & humor
  • Command over voice

10) General Awareness:

You are required to be aware of the current happenings, changing scenarios in political and business world, society, etc.

GK-based questions assess your ability to process current and past information.

11) Honest, Trustworthy, and Reliable:

“These are three cornerstones of good character,”.

“You can tell a hiring manager that you are these things, but your demeanor and the conversation will be far more credible. They are critical because trust is at the core of any sustainable relationship.”

12) Respectful:

One of the biggest deal breakers in an interview is a job candidate who is disrespectful, which can take many subtle forms (like bringing in coffee, looking at your cell phone or forgetting to turn it off, or acting haughty).

Remember your ‘please’ and ‘thank you’; wait to be asked before you’re seated; and offer your undivided attention.

13) Passionate:

Hiring managers want to know that you love your work and field, and care about outcomes.

Let them know that you follow the industry closely, and aspire to constantly learn and contribute more

14) Professional:

Professionalism takes many forms, but erring on the side of conservatism is always your best bet.

You can and should be friendly, but don’t act like the interviewer is your Closed friend.

Dress professionally, show up on time, be polite, and stick to appropriate topics of conversation.

15) Team Oriented:

Interviewers are attracted to team players; those who know it takes more than one person to get the job done.

Employees are judged for their ability to perform in a team or group, by willing to co-operate as per the guidelines and adding to team cohesion.

They should be able to perform well in different roles or positions within a team without any hassles.

This quality can also reflect in the employee’s personal life and sometimes the Job Interviewer may indirectly ask questions about their co-operative behavior.

16) Results-Oriented:

It’s one thing to talk about how great your skills are, but another to prove it.

Give with help of examples of how you achieved specific results,

for example: “We increased sales 20% in six months,” or “Turnover dropped to 5%,” or, “I led the team that landed the XYZ account.”

17) Flexible:

The only thing that remains the same is change, and the workplace is no exception.

If you can demonstrate that you can switch gears with poise, as circumstances require, that will advance your cause.”

18) Maturity:

What about your overall sense of balance? Can you make value judgments and decisions?

19) Dedicated:

Interviewer knows that you do what it takes to get the job done. If you’re in a managerial position that means you may have to work longer when there’s a deadline and deliver on your promises.

20) Diligence:

How committed an employee is to the company matters in the long run, while commitment towards day-today tasks determines their efficiency.

21) Confident:

There’s a fine line between appearing confident and haughty. There’s also a fine line between being humble and self-effacing.

Find a place in the middle, and speak with pride about your work without sounding like a braggart.

You can demonstrate your confidence by your posture, smile, pacing, and examples of successful projects.

21) Sense of Humor:

A sense of humor is appealing to most interviewers because they know that when the chips are down, levity can go a long way.

Clever, well-timed humor demonstrates intelligence and that you can put others at ease.

22) Enthusiastic:

If you can’t get excited about the company in the interview, then how motivated can you be once on board?

“This is standard thinking among hiring managers,” she says. “My best hires, without exception, have always been those who are genuinely eager, energetic, and upbeat.”

Taylor says it can help to keep in mind a personal phrase that keeps you on your game, such as, “Be amazing!” “I’ll crush this!” or “I love this job!”

“This doesn’t mean being giddy, but looking as if your cat died won’t help you, either

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Root Causes of Data Integrity Issues

Data Integrity App

In simplest terms, if your data can’t be trusted, neither can you.

The integrity of the data collected and recorded by pharmaceutical manufacturers is critical to ensuring that high quality and safe medicines are produced.

Data integrity issues impact the entire company, bringing into the question the capability of those tasked with assuring quality and managing the operation.

Your company’s executive management is responsible for ensuring the quality, safety, and integrity of your products. Implementing adequate controls and systems to prevent manipulation of laboratory data is at the foundation of fulfilling this critical responsibility.

Data integrity is mandatory for the regulated healthcare industry, as processing and disposition decisions regarding product quality, safety, efficacy, purity, and compliance with the applicable regulatory requirements are made based on data that is recorded and reported.

What happens when data integrity is breached? The worst case scenario is impact on patient safety and the loss of lives.

Some of Root causes of Data Integrity Issues

  1. Shortage of Manpower

Shortage of staff and excessive work pressure can lead to inaccurate and incomplete documentation.

2. Always follow a written procedure:

In Many 483 and warning letters, procedures do not include the level of detail that allows for consistent performance.  Variability in performance equals variability in output and, subsequently.

3. Quantity Vs Quality:

Employees may be forced to compromise the acceptable quality levels in order to meet production targets or dispatch timelines.

All data must always be recorded as part of the official record.

As per written procedures, all data generated must be captured and documented appropriately even data that is invalidated due to known errors.  Without it, we lack a complete trail of our activities and decisions for each batch of product produced and tested.

4. Lack of Awareness:

Often, employees are not trained or inadequately trained to understand GMPs. This causes employees to consider activities as a chore rather than understanding their relevance in light of GMP.

5. Effectiveness of Training:

While the company may hire the best international trainers, employees mentioned that there were language and accent barriers, which prevented the employees from understanding the content, thereby making the training redundant. K

• Time Pressure

• Insufficient education & understanding (WHY)

• Fear for mistakes

• Performance Pressure

• Am told by leader

• Reputation

• Money

• Culture or accepted behavior

6. Data Maintenance and archiving:

  • Access controls, including sharing of passwords and providing unauthorized personnel access to edit/delete programming or critical data
  • Failing to backup data or protect records from accidental deletion/ Altering/Overwriting of Data.
  • Hybrid systems lacking processes to manage/maintain both the paper and electronic components of the system
  • Retention of raw data or of the complete data acquired or generated during a process
  • Problems with issuance, use or control of batch records, worksheets, and notebooks

7. Equipment/Systems

 Verify that the elements that ensure accuracy and control of equipment and systems are in place and functioning, including:

  • Alignment with GAMP 5, GAMP Good Practice Guides and/or USP expectations, as appropriate
  • Validating/qualifying of equipment, test methods, computer processes & data calculation/information transfer mechanisms to ensure accuracy and correct performance prior to use
  • Appropriate levels of user roles, security, policies & Limited access to data are defined and have been verified to function as expected
  • Always enable audit trails

8. Supplier Quality:

Quality agreements (with suppliers, contract labs or contract manufacturing organizations) should be in place.

Across the internet, there are millions of resources are available provide information about almost everything.

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

Objectives of Interview

Mind Blowing App

Objectives of Interview:

Interviews an effective tool for selection. It is a two way communication between interviewer and interviewee.

Information flows in both directions. recruiter learns about the applicant and the applicant also gets a chance to know about the employer.

So, why are the interviews carried out? In what way does it help the interviewer zero in on the right candidate?

In the selection process, interview serves the following objectives:

  1. Interview gives an opportunity to the interviewer to know about the applicant. Verifies quality and accuracy of information obtained through application form and tests.
  2. Interview helps to obtain additional information from the candidates as required by the job.
  3. Verifies the candidate has written in the CV are the main points. What other additional skill set does he have? All these are known by conducting interviews.
  4. Gives the candidate necessary facts and information about the job, organization policies, products manufactured and so forth.
  5. It not only gives the interviewer information about the candidate’s technical knowledge but also gives an insight into his much needed creative and analytical skills.
  6. Interview helps to establish mutual understanding between the company and candidates. Also create a good image of the company, among applicants.
  7. Interview beneficial for the interviewer and the interviewee as individuals, because both of them gain experience, both professionally and personally.
  8. Interview helps the candidate to assess his creative and analytical skills and know where he lacks and the places where he needs improvement.

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What is Data in Pharmaceutical Industry?

What is Data?

“Facts, figures and statistics collected together for reference or analysis. “

All original records and true copies of original records, including source data and metadata and all subsequent transformations and reports of these data, that are generated or recorded at the time of the GXP activity and allow full and complete reconstruction and evaluation of the GXP activity.

Data should be:

A – Attributable to the person generating the data

L – Legible and permanent

C – Contemporaneous

O – Original record (or true copy)

A – Accurate

Source MHRA GXP Data Integrity Guidance and Definitions; Revision 1: March 2018

ALCOA Meaning Explanation

A: Attributable:

Who performed an action and when? If a record is changed, who did it and why?

Who did it? Source Data

L: Legible:

 Data must be recorded in a permanent durable medium and be readable

Can you read it? Needs to be permanent

C: Contemporaneous:

Data must be recorded when it was performed followed by date and time.

Was it done in real time?

O: Original:

Is the information the original data or a certified true copy of the original data?

Is it original or true copy?

A: Accurate:

No errors or editing performed without documented amendments

Is it accurate?

Data governance measures should also ensure that data is complete, consistent, enduring and available throughout the lifecycle, where; 

Complete – the data must be whole; a complete set  

Consistent – the data must be self-consistent  

Enduring – durable; lasting throughout the data lifecycle 

Available – readily available for review or inspection purposes 

Data may be generated by:

(i) Recording on paper, a paper-based record of a manual observation or of an activity or 

(ii) Electronically, using equipment that range from simple machines through to complex highly configurable computerized systems or 

(iii) By using a hybrid system where both paper-based and electronic records constitute the original record or

(iv) By other means such as photography, imagery, chromatography plates, etc.

Raw Data:

Raw data is defined as the original record (data) which can be described as the first-capture of information, whether recorded on paper or electronically. Information that is originally captured in a dynamic state should remain available in that state.

Raw data was first defined in the FDA’s Good Laboratory Practice regulations in 1978 (1) and was described in 21 CFR 58.3(k) as:

“Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof; those are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. “

Meta Data:

Metadata is nothing but data about data which gives information about data. Metadata is data that describe the attributes of other data, and provide context and meaning.

Metadata is structured information that describes, explains, or otherwise makes it easier to retrieve, use, or manage data.

Simply, these are data that describe the structure, data elements, inter-relationships and other characteristics of data. It also permits data to be attributable to an individual (or if automatically generated, to the original data source).

For example, the number “23” is meaningless without metadata, such as an indication of the unit “mg.”

Transient Data

Transient data is not defined as an electronic record. It is the data generated by a computer that is not retained or stored by the system, although it may remain in the computer’s memory for a significant period.

Transient data is unalterable by the user while it remains in memory. Transient data may be sent to a printer, processed further by the system, or transmitted to another computer system, where it may or may not become part of an electronic record.

But if the system enables the stored data to be modified, then the stored data constitutes an electronic record, and it cannot be considered transient data.

Across the internet, there are millions of resources are available provide information about almost everything.

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free “Data Integrity” app & stay updated in world of Pharma IT compliance.

What is Interview ???

Introduction

“Luck is what happens when preparation meets opportunity.” –Seneca, Philosopher

The word interview comes from Latin and middle French words meaning to “see between” or “see each other”.

Generally, an interview means a private meeting between people when questions are asked and answered.

The person who answers the questions of an interview is called in the interviewee. The person who asks the questions of an interview is called an interviewer.

There are some easy steps that you can take that will increase your chances of success at interviews. 

First, remember that job interviews should be a process of two-way communication. Not only are they a tool for employers to use to evaluate you, but they are also an opportunity for you to assess the job, the organization, and to see if there is a “fit.” 

Be prepared to the best of your ability. There is no way to predict what an interview holds, but by there are some important rules you will feel less anxious and will be ready to positively present yourself during interview.

Mental fear of the unknown is often what produces the physical symptoms of nervousness. In addition to preparing yourself physically, you need to prepare yourself mentally. The best way to prepare mentally is to know what may be coming. Fear of the unknown can only exist when there is an unknown.

It is your opportunity to find out more about the position and it’s an opportunity for the interviewers to assess whether you have the relevant skills and experience required.

The interviewers will be looking for someone with confidence and character, who is a team player and will fit in within their company. They will be able to provide more information about the role and the company during the interview.

You prepare answers to commonly asked questions so you can respond confidently and concisely. You may be asked why you are seeking alternative employment, more about your current skills, workload and experience, your long term plans and what you can offer the company.

The keys to a successful interview are preparation and practice.

What is an Interview?

When you split the word ‘interview’ you get two words, ‘inter’ and ‘view’. This roughly translates to ‘between view’ or seeing each other.

An interview is a formal consultation or meeting for the purpose of ascertaining and evaluating the qualifications of a person, group of people, or company to fill a particular job situation.

It can be simply defined as the formal meeting between two people where the interviewer asks questions to the interviewee to obtain information.

An interview is beneficial to both the candidate and the organization, for it helps them to grow.

The interview process is a two-way street. You are traveling toward a goal—the right job and the employer is traveling toward a goal—the right hire.

During the job interview, the employer has the opportunity to appraise applicant’s qualifications, appearance and general fitness for the job opening.

In parallel the applicant tries to learn more about the position, to appraise the employer and to find out if your needs and interests will be met.

Depending on the size of a company and its organization, an applicant may only have one job interview. This is common with small businesses, in which candidates are often interviewed directly by the employer.

In other cases, a representative of the human resources department may interview a candidate first, and then he or she will go through a series of interviews with potential supervisors and other personnel.

Larger companies may also have interview panels with multiple members who cooperate to make a decision.

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History of Computer System Validation in Pharmaceutical Industry

History of CSV:

History:               

The concept of validation was derived from engineering principles of validation of           mechanical system that has been extended to the software industry.

To extend it further during mid-1970’s, Ted Byers and Bud Loftus, two Food and Drug Administration (FDA) officials first proposed the concept of validation in order to improve the quality of pharmaceuticals (Agalloco 1995).

In 1987 the FDA published a document entitled ‘FDA Guidelines on General Principles of Process Validation’.

It state that

“Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.”

Feeling the necessity of Validation, FDA published a guide to the inspection of Computerized Systems in Pharmaceutical Processing, also known as the ‘bluebook’ (FDA 1983).For MHRA this is Annex 11 of the EU GMP regulations (EMEA 1998), whereas for American FDA, this is 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997).

FDA issued final part 11 regulations In March of 1997, became effective in August 1997 & Revised in August 2003.

Basics of Computer System Validation:

According to both American FDA and UK MHRA, computer system validation is defined as “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”

Validation of computer systems is not a onetime event it periodic activity.

CSV should be performed by person other than those responsible for building system.

Purpose of CSV:

The purpose of the validation process is to provide a high degree of assurance that a specific process (or in this case computer system) will consistently produce a product (control information or data) which meets predetermined specifications and quality attributes.

Need of CSV:

FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of law.

Having the evidence that computer systems are correct for their purpose and operating properly represents a good business practice.

Failure to take corrective action in a timely manner can result in shutting down manufacturing facilities, consent decrees, and stiff financial penalties.

Principle of CSV:

Validation of computer systems is not a onetime event.

List of Guideline

Following is the list of some Validation Guiding Specification commonly used in validating Laboratory Automation System:

  • General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 21 CFR 11, 21 CFR 820.
  • GAMP (Good Automated Manufacturing Process).
  • PDA Technical Report 18, Validation of Computerized Systems.
  • ASTM E2066-00 Standard Guide for Validation of Laboratory Information Management Systems.
  • NRC Regulatory Guide 1.170 in compliance to 10 CFR 50.
  • 1012-2004 IEEE Standard for Software Verification and Validation.

Across the internet, there are millions of resources are available provide information about almost everything.

Here all useful Pharma IT Compliance & Inspection preparation information is available in your hands for your ready reference.

We recommended you this “Data Integrity” App which contains most important Pharma IT Compliance tricks & techniques which help you to understand

  • Current Regulatory Agencies thinking on Data Integrity.
  • Importance of Mock Inspection & its tricks and techniques how to conduct.
  • Checklist for Inspection
  • Best Practices for CSV.
  • Useful Resources & References

So, let’s try this Free Data Integrity app & stay updated in world of Pharma IT compliance.

Team Innovative Appz

 

 

Innovative Appz

What we are

We Passionate in Human Research/ Pharma Regulatory Compliance (Data Integrity & CSV) Entrepreneur and founder of the Innovative Appz.

We are offering worldwide apps which provide guidance to Job Seekers, Career Changers, those in transition on most effective methods of self-marketing, networking, & relationship building and Pharma Compliance Officers (Data Integrity & CSV).

OUR SERVICES

We have developed apps which add values in your professional career & Get Guarantee to achieve your Goals.

– Job Hunting Methodology
– Interview Preparation techniques
– Job Search techniques and Mindset Coaching
– Toughest Interview Question & Answer.
– LinkedIn Profile Optimization
– LinkedIn Strategy
– CV Optimization
– Work Etiquette
– Pharma Regulatory Compliance (Data Integrity & CSV)

Our Apps optimized your CV’s, Maximized LinkedIn Profiles, Aced Job Interviews, and Landed Dream Job.
Enjoy ours Apps & share your valuable comments/feedback for further improvement.

ALL THE BEST!!!
From Team Innovative Appz

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