The Justice Department announced that yesterday a federal court in Ft. Worth, Texas permanently barred Karena Mondrianh, of Southlake, Texas, from preparing tax returns and from operating a tax-preparation business.

A former LaPorte County deputy auditor has been indicted by a federal grand jury in the Northern District of Indiana for embezzling over $150,000 from the LaPorte County government and committing tax fraud.

You know you need a computer systems audit, but that’s literally the extent of what you know.
Has this ever been you?

Yes, you use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply. Terms like “cloud computing” make you feel slightly queasy. You’d rather get a root canal than discuss “distributed processing.” Your expertise is in manufacturing. Or clinical research. Or non-clinical lab operations. And somehow it’s your job to make sure an effective and properly-sized system audit is conducted. Great.



Yet your Quality Assurance colleagues -- whether they’re from your internal QA department or an external compliance company -- need your input. They need to understand what software is being purchased, what services are being contracted, how and where components of the system are being implemented, and how the system will be used.

The good news is that the QA auditors can help you. They know that FDA favors a risk-based approach to validation and Part 11 implementation, and they even know what that means. They love to talk about configuration management and change procedures. They love gathering evidence that demonstrates your system works correctly and is in a state of control, and they know what rocks they should look under to find and fix vulnerabilities.

What follows are examples of the types of information you need to convey to QA – and that they should be asking you about – to properly size and scope an audit.

How do You Plan to Use the System?

Suppose you need to audit the supplier of a new Document Management System. The first thing an auditor would need to understand is how you plan to use the system. How mission critical are the documents you’re looking to store?  Are they covered under regulatory scope?  Maybe you plan to use the system as a collaboration environment for developing new SOPs. That would require a relatively low level of scrutiny, especially if you only plan to print out the finalized documents for wet ink signature. (As a point of comparison, if you plan to use the system to finalize SOP approval, the auditor would need to check that Part 11 requirements for electronic signatures are properly implemented.) What if the Document Management System will be housing critical GxP documents, such as Trial Master Files, Master Schedule Sheets, or Master Batch Records? In these cases, the validation would have to be far more thorough, and Part 11 electronic record features, such as audit trails and archiving functionality, would have to be implemented and verified.

Here’s another “use” example. Similar to the term “Document Management System,” the term “Analytics System” does not tell the whole story. From a business perspective, study start up (SSU) metrics may be vital for sponsors and CROs to collect and analyze. But since they have no regulatory impact, the FDA would not require an SSU analytics system to be validated. (That doesn’t necessarily mean you might not want to, though.) On the other hand, a system that performs statistical analysis on study data for regulatory submission is about as critical as it gets, and would require thorough validation and Part 11 implementation. Other analytics systems, such as dashboards that pull data from critical systems, might fall somewhere between these two extremes.

What is the Vendor Providing? And How? And Where?

If you need to audit a complex system, the questions QA will ask you will go beyond system use. The auditors will need to understand the combination of software and services the vendor is providing, and where the software and data reside.

• Does the software and data reside internally at your company or does the vendor provide a hosting service?
  If the vendor is hosting, the auditor needs to tour the facilities and review SOPs and records to evaluate physical security, staff training, environmental controls, backup procedures, disaster recovery plans, data retention, computer infrastructure, and change control.
  
  
• Does the hosting vendor own its own servers or does it, in turn, outsource that function to a 3rd party hosting company, (possibly even in the cloud)?
  If the hosting is outsourced, ideally an auditor would be able to visit the hosting site. Failing that, the auditor would ask questions about the vendor’s qualification processes and review SOPs that govern vendor selection/management procedures. If the vendor outsources other services beyond hosting, those services might need to be considered, as well.
  
  
• Is the vendor providing any other services?
  Many EDC vendors will provide study-specific services such as screen development and data entry validation edits. Auditors would need to review SOPs for providing these services and understand how the vendor tests and manages modifications to these components as the study proceeds.
  Sometimes computer systems vendors provide ancillary services, such as help desk functions and user account management. That would mean additional SOPs and training records for the auditor to look through.

Other Considerations

There are many. For example, where are you in the product life cycle? You ask different questions about a new system than you would about one that has been operating for a few years. Is the product Commercial off-the-shelf (COTS) or highly customized? COTS systems vendors often have their own validation package which auditors would review, and then ensure proper operation in the sponsor/CRO’s specific environment. A highly customized or custom-built system would require a more extensive validation process.


The Take Away

CSV/Part 11 audits will never be standardized, cookie cutter type activities; there are simply too many factors -- in too many combinations -- to consider. You want your QA efforts to be worth the money you spend and be able to answer the questions FDA says you need to be asking. If you’re unsure how to do that, that’s ok. Other people know, as long as you can help them understand how you plan to use the system, what software and services are being supplied, and how components of the system are being implemented.

In case you missed it, our previous post was Notes 2 Fix Your Notes 2 File.
_______________________________________________
Many thinks to Lisa Olson for sharing her insights with me.

Last month, I scheduled one-on-one discussions with our most experienced GCP auditors to ask each of them the same question: What surprises you most about the audits you conduct?

I guess you could say that I was the one who was surprised. I’m not sure exactly what I was expecting to hear, but I thought my teammates were going to talk about things that were new. Instead, I heard a lot more about things that have been around for a long time. To a person, my colleagues said they were surprised to be observing some of the same audit findings they were observing 30 years ago...which *is* surprising when you consider most of them were mere children at the time. ;-)  It seems we have some stubbornly persistent quality and compliance issues in the biopharma industry that decades of neither experience nor technology have seemed to remedy. And the problems are not just persistent; they’re interrelated.



Standard Operating Procedures (SOPs)
It’s quite common for auditors to encounter sponsors, CROs, and sites that lack an adequate set of SOPs to describe local procedures. There are several reasons for this. Sometimes it’s a lack of resources. Sometimes smaller, established organizations believe writing it all down is unnecessary, as “people know their jobs.” Sometimes newer companies are simply unaware that written procedures are required for particular operations. But when procedures are not documented, organizations are unable to demonstrate GCP compliance, cannot ensure that activities are performed correctly or consistently, and have difficulty training new staff members. (We’ll come back to training in a bit.)

Frequently missing from a good working set of SOPs are procedures for Disaster Recovery, Handling of Suspected Fraud, and Management of Regulatory Inspections. These SOPs are not used for day-to-day operations, so perhaps that’s why they don’t garner as much attention. Nevertheless, the inability to recover from a disaster, protect the organization from fraud allegations, or pass a regulatory inspection can sink a company.

A fourth SOP that is commonly absent from the set is the document that describes how to write, approve, distribute, revise, and retire SOPs. Also frequently missing from a working set of SOPs is our next topic: Training.

Training
Training can be expensive and time-consuming, and companies increasingly have to do more with less. In-person training has largely been replaced by computer-based systems, on-site training has given way to distance learning, and mentoring has gone the way of the dodo.

The good news is that study sites typically adhere to formal GCP training requirements. What’s often missing, though, is the training that connects GCP concepts to everyday activities. A trainee might correctly answer a multiple-choice question about audit trails, but without that “last mile” of coaching, use Wite-Out to correct a source document error. This is where SOPs come in. When training is conducted using well-written SOPs, it can help bridge the gap between standard GCP training and specific site operations.

It is not uncommon for study-specific training to be lacking in CROs – protocol training, device training, computer systems user training. As part of their vendor oversight procedures (also an SOP!), sponsors should be making sure that CRO staff is adequately trained. 

Trial Master Files (TMFs)
Whether paper or electronic, it’s common for TMF documents to be missing or expired. Replacements for these documents can usually be produced and filed at the time of the audit. Misfiled documents are another matter; they are already there but cannot easily be found. Locating and refiling them essentially doubles the time and cost of the original effort. For example, documents from multiple labs, such as certificates, credentials, vendor audit results, etc., are often mistakenly commingled. Documents must be sorted and refiled so that each facility listed on the 1572 has its own file or electronic folder.


Another very common mistake is treating every document on letterhead as if it’s general correspondence. Search for the word “letter” in the DIA Reference Model and you can see how many opportunities exist for misclassifying correspondence. For example, an IND safety report sent by the sponsor on letterhead should be filed under “Notification of Safety Information,” Section 8.3.18 in ICH E6(R2), not “Relevant Communications,” Section 8.3.11. In an eTMF, an IRB approval letter belongs in 04.01.02, its designated DIA Reference Model position, not 04.04.01, which is reserved for general communication.

The root cause of these misfilings? The filer does not know enough about the filing structure of the TMF and often is not familiar enough with clinical research to know the purpose of each document and where it belongs. The corrective action? Training. Training on the TMF plan, the TMF Management SOP, ICH GCP, and study operations in general.

Technology to the Rescue?
No doubt, CTMSs, eTMFs, eCRFs, ePRO, and other systems have improved clinical operations and reduced error. However, three decades of technological advances have done little to address the most common quality and compliance issues encountered by GCP auditors – and by extension regulators. Some might find that discouraging, but isn’t it also a little satisfying that the solution to our most persistent problems comes down to human communication?

______________________________________________________________________
A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

In an effort to tease out the priorities of a clinical study site audit, I asked six of our most experienced GCP auditors the following question:

If you only had one hour to conduct a study site audit,
what would you look at?
[Obligatory warnings:  Do not try this at home. This is just a simulation. Caveat lectorem. Dinosaurs in the mirror are bigger than they appear. Et cetera.]

Of course it’s not possible to conduct any kind of meaningful audit in so short a time, but it’s an interesting thought exercise because it gets to the heart of study site risk.
In order to respond to this question, the auditors needed to ask themselves:

(1) What are the greatest site risks to a study?
(2) Where can evidence be found that those risks are being managed?

Answering the first question is pretty easy. The very first paragraph of ICH E6(R2) tells us “Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected…and that the clinical trial data are credible.” So there it is: the reason GCP exists. When we conduct clinical research, our highest priorities are human subject protection and data integrity. It follows, then, that jeopardizing these obligations is our greatest risk.

So with only an hour to evaluate whether a study site is managing these risks, we can move on to the second question. What would our audit (now referred to as “hour audit”) look like?

IRB Approvals

Hour Auditor has decided to spend the first twenty minutes at the site reviewing IRB approvals. Are all of the IRB approval letters in the Investigator Site Files (ISF)? Is the protocol that’s being executed the same version that the IRB approved? Have the protocol amendments and all of the associated Informed Consent Forms (ICFs) also been approved?

Missing approval letters aren’t necessarily the end of the world. It’s quite possible that the required approvals are sitting on the sponsor portal, having been received from a central IRB. Their absence from the ISF could just be a clerical error. However, it’s a first-order finding if the site was responsible for getting approval from its local IRB and failed to do so. The IRB would have to be notified. The FDA would have to be notified. Without review and approval from an ethics body, the safety of study participants is jeopardized and their rights violated. Everything stops.


Informed Consent

With forty minutes left to go, Hour Auditor spends the next twenty minutes reviewing participants’ ICFs. The selection of these participants may be random or targeted, depending on the results of the IRB approval review. Has each participant signed every applicable version of the ICF? Were they signed before any associated study procedures were conducted? If not, was the delay noted in the subject notes? How was the situation remedied? Was there a CAPA to ensure that any other incidents were corrected and future occurrences prevented? Was the IRB informed?


Inclusion/Exclusion Criteria

Now down to the final twenty minutes, Hour Auditor asks to see the Inclusion/Exclusion (I/E) criteria for two screened and enrolled participants. Most likely, the particulars of the study -- the vulnerability of the patient population, the therapeutic area, and the protocol complexity, among other things -- would drive the selection.

We’re running out of time, and this could be our final stop. With so much else to look at, including source data, IP accountability, staff qualification and training, and Adverse Events reporting, why focus on I/E criteria? Because they give us a glimpse of many aspects of study conduct all at once. When a site can assess complex I/E criteria correctly, it demonstrates protocol compliance and a commitment to producing reliable study data. Examining I/E criteria also gives Hour Auditor a chance to assess source data quality and provides further assurance of subject safety.

Best Laid Plans
As with any audit, particular findings at any step could (and should) alter the plans for this one-hour visit. If the ICF review left Hour Auditor concerned about fundamental flaws in the IC process, the rest of the audit might be spent trying to determine the extent of the problem. An incidental discussion could raise red flags about staff proficiency that may have Hour Auditor poring through protocol training records or scrutinizing the Delegation of Authority log. (Plus, Hour Auditor really, really wants to take a peek at the IP accountability records, and so may find a reason to do so*.)

The point of this thought exercise was to consider (1) the obligations of the clinical research industry to protect subjects and produce reliable data, (2) where the biggest risks to that obligation lie, and (3) how site audits should be prioritized to ensure those obligations are being met and those risks are being managed.

_________________________________________________________________________

*The auditors involved in this discussion did their best to honor the absurdly artificial time constraint I gave them. That meant foregoing activities no self-respecting auditor could bear to forego. This paragraph recognizes some of those activities. (Thank you all. I know this hurt.)

A version of this article originally appeared in InSite, the Journal of the Society for Clinical Research Sites.

Alarm Clock Image via Good Free Photos

Guest Blogger: Greg Weilersbacher
Founder & President, Eastlake Quality Consulting

All companies outsource. It’s a humbling fact that you simply can’t do it all yourself. This often has to do with resource allocation; your company may allocate dollars to build and sustain some activities in-house while choosing to contract higher-cost operations to qualified suppliers who already have the expertise and equipment. 

You may outsource the manufacturing of tablets, sterile injectable, or topical dosage form, or the GMP release and stability testing of your product. Once the production and testing is complete, the product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The Contract Development and Management Organizations (CDMOs) who execute these critical operations are of paramount importance to your company’s success. Choosing the right suppliers will also help to minimize stress-induced headaches throughout your organization. Here are the top five ways to get the most out of a supplier audit.



1.  Come to the Audit Prepared
This seems obvious. However, more often than not, quality auditors step into the supplier’s lobby without doing their homework. Ask yourself the following questions: Why am I auditing this supplier? Is this supplier new to my company or one that we have used before? If used previously, have I read over the audit observations as well as the supplier’s responses and do I understand them? Which audit observations do I suspect would be the most challenging for the supplier to address and which are most important to my company’s requirements for this product? Have I reviewed previously executed production batch records and testing data and are there issues that need to be resolved? Are their deviations and CAPAs to follow up on?

Your understanding the supplier’s work proposal is of great value in refining the scope of the audit. Ask yourself:  Which of our products may be manufactured and tested here and which strengths (e.g., potency) will be produced? Which equipment is likely to be used? For a tablet production, the equipment train could include balances, blenders, roller compactor, spray dryer, solvent-rated oven, comils, tablet press and tooling, gravity feeder, coating systems, de-duster, weight sorter, metal detector, tablet counter, etc. This list of equipment will assist you in requesting equipment records during the audit. 

2.  Stay On Point
Proper audit planning will help to keep the audit organized and adhere to the audit timeline. In advance of the audit, provide the audit host with a list of the technical, lab, and manufacturing staff you wish to speak with and the records you need to review. A well-organized host will have this available for your review. Stick to your audit agenda. This is critical. The best way to derail your progress is to spend precious time chasing down minor issues while glaring problems get little to no attention. Continually refer back to the audit agenda and remember to keep the content of your audit report in mind while executing the audit.


3.  Know Your Technical Expertise and Limitations
Many auditors have led previous lives in the laboratory or in manufacturing while others started their careers in quality assurance and may have little technical background with regard to equipment, manufacturing processes, GMP utilities and laboratory testing. Know your limitations and if necessary strengthen them by hiring an expert consultant to assist you during the audit.

A common problem area that is at best glossed over and at worst completely ignored during an audit is the CDMO’s compliance with GMP utilities requirements. All too often, this is due to the auditor’s lack of understanding of the operation, inputs and outputs, validation parameters, and periodic testing and maintenance requirements for utilities such as HVAC, clean or pure steam, purified water and WFI systems, autoclaves, clean compressed air, nitrogen and other gases used for operating equipment or used during processing activities in manufacturing. Typically, these areas are also less well understood by the CDMO’s employees and as a result noncompliance abound. 

Some GMP utilities may be connected to the facility’s building management system, while others may be stand-alone equipment. In either case, the CDMO should have records of alarms (e.g., out of specification or out of range conditions), an acknowledgement of each alarm by designated staff members, and documentation of corrective actions. The last item is key. This is where the execution of quality systems tends to fail. Make a point to request documentation of corrective actions for each utility alarm. 

Additionally, purified and WFI water systems along with gases, such as clean compressed air and nitrogen, require periodical sampling/testing at each point-of-use. Verify that the timelines (monthly, quarterly, or annual) for sampling and testing were performed as directed by the CDMO’s procedures. These timelines are typically not well adhered to. A clear understanding of all the operations of the supplier’s GMP utility management process will keep your thoughts clear during the audit and help identify areas that are in need of improvement. 

4.  The Auditor’s Job is to Identify the Good and the Bad (Not to Win the Debate)
An important goal of a supplier audit is to identify the supplier’s strengths and weaknesses and come away from the audit with a compliance assessment that your company can use to make important decisions. It is of no value to your company if the goal of the auditor is to show the supplier how much he or she knows by debating the fine points of compliance. GMP auditors with decades of experience generally avoid this competitive exchange as it is unproductive. Rather, it is more important to the spend the necessary time identifying compliance issues, making them known to the audit host in a professional manner, and taking detailed notes that assist in writing the audit report. Your company’s senior managers need to know the supplier’s good and not-so-good points; detailing all of these provides the greatest value. 

5.  Interview the CDMO's Lab Staff, Manufacturing Operators, and Shipping/Receiving Personnel
CDMO’s quality systems are generally written by managers and directors who have many years of industry experience. It is of utmost importance that staff members who execute these systems understand them if your company’s product is to be manufactured, tested, stored, and distributed in a compliant manner. Request to speak with manufacturing staff members who work on the production floor and are likely to work on your product. Ask them about the process they would follow to conduct lines clearance, charge powders to a blender, operate a spray dryer, use a comil, set-up of a tablet press, inspect tablets, use metal detectors, etc. Compare the information they provide to the CDMO’s SOPs to determine if the staff understands their jobs. Listen for phrases such as “I usually do it this way…” or “it’s a different every time but I typically set up the equipment like this…” These phrases reveal a lack of control and adherence to procedures. 

The Take Away
The audit itself lays the foundation for a relationship with the supplier and the take-away message should address the following questions: Will the supplier work to resolve the issues I’ve identified? Am I confident that the supplier will immediately notify and involve my company’s representatives when deviations occur during production or testing? Do the supplier’s quality systems and records meet my company’s requirements and those of regulatory agencies? How confident am I that the supplier will produce and/or test a quality product that my company can stand behind? Is the supplier simply a pair of hands or are they committed to be my partner in this product’s success? The answers will provide you with a comfort level in making the decision to move forward with the CDMO or to look to the their competition.  

*********************************************************************************

A version of this article was first published in Outsourced Pharma.

 About the Author
Greg Weilersbacher is the Founder and President of Eastlake Quality Consulting, a GMP consulting firm based in the Southern California area. Over the last 25 years, he has held director and vice president positions leading Quality Assurance, Quality Control, Analytical Chemistry, Materials Management, GMP Facilities, and Product Manufacturing in biotech and pharmaceutical companies. His unique experiences and technical background have led to the manufacture and release of hundreds of solid oral, sterile, and biologic investigational products to clinics in the U.S. and abroad. Email Greg at weilersbacher.greg@gmail.com.

When it rains guidance, it pours. The MDCG just released Guidance on temporary extraordinary measures related to medical devices Notified Body audits during COVID-19 quarantine orders and travel restrictions. The guidance takes immediate effect and is valid for the whole period of duration of the pandemic COVID-19 as declared by the World Health Organisation. It […]

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Bank audit revision notes by CA Ekta Shah prepared from ICAI Module covering all questions

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Following an outcry from the residents of Dosti Blossom and Dosti Daffodil, the Brihanmumbai Municipal Corporation (BMC) has decided to appoint IIT-Bombay or VJTI engineers for a structural audit of the buildings, to ascertain damage to them due to excavation on the adjoining Krishna Steel plot.

On Monday, a huge landslide at the neighbouring Lloyds Estate raised serious questions about the construction going on Krishna Steel plot, which is being developed by the builder Dosti Realty Ltd. After the accident, residents of Lloyds Estate, Dosti Blossom and Dosti Daffodil alleged that the builder was doing excess excavation at Krishna Steel plot and weak shore piling has been damaging their buildings for the past year. They also claimed no action was taken by BMC and the developer to avert a mishap.

Commissioner's approval needed
Speaking to mid-day, deputy chief engineer of the Building Proposal (BP) Department (city), R S Potdar said, "We have prepared a proposal to appoint experts like IIT-Bombay or VJTI for a structural audit of these buildings. Since we don't do structural audits of private buildings, we will have to take approval from the municipal commissioner. After that we will decide the further course of action." However, residents of Dosti Blossom said that they don't know anything about BMC's plan of appointing IIT-Bombay or VJTI experts. "We met officials from the building proposal department on Wednesday but there was no word about any such plan," said a resident.

'BMC harassed us'
Residents of Dosti Blossom and Dosti Daffodil buildings have alleged that last year when they raised an alarm over the sinking portions of their compound and cracks in their buildings due to excess excavation done at Krishna Steel plot, the BMC harassed them instead of taking action against builder. On Thursday, committee members of Dosti Blossom and Dosti Daffodil showed their letters to different civic departments regarding the dangerous condition of their buildings.

Manoj Gurav of Dosti Blossom said, "Last year after April we observed cracks on the building columns and sinking in the parking area which is adjoining the plot where excavation is going on. A huge portion of our parking area had sunk about a foot. Following this we had sent letters to the builder and the BMC to take action and make the premises safe." He added, "Instead of taking action against the builder, the F-North ward of the BMC sent us a letter, and held us liable for the damage done to the building. BMC officials told us to carry out a structural audit otherwise action would be initiated against us."

Also Read: Lloyd estate wall collapse: BMC bars Dosti Realty from construction at Wadala site

Catch up on all the latest Crime, National, International and Hatke news here. Also download the new mid-day Android and iOS apps to get latest updates

As Bollywood's 'Queen,' Kangana Ranaut completed 14 years in the Indian film industry on Tuesday, her team shared a throwback picture from one of her early portfolios. The 33-year-old actor was shortlisted for an audition for her debut film 'Gangster' on the basis of the picture that her team shared on Twitter.

The priceless picture from the past featured a younger version of the actor with her signature curly locks and bold expressions.

#Trivia: On 14th anniversary of #KanganaRanaut ’s Bollywood debut #Gangster, here’s the image from her portfolio on basis of which @anuragbasuofficial selected her for an audition#Throwback #14YearsofKanganaRanaut #14YearsofGangster pic.twitter.com/CkDWat9TJv

— Team Kangana Ranaut (@KanganaTeam) April 28, 2020

Ranaut is seen wearing a white and brown coloured muffler in the picture.

"#Trivia: On 14th anniversary of #KanganaRanaut 's Bollywood debut #Gangster, here's the image from her portfolio on basis of which @anuragbasuofficial selected her for an audition #Throwback #14YearsofKanganaRanaut #14YearsofGangster," Kangana's team tweeted along with the picture.

Kangana Ranaut stepped into Bollywood at a very young age and began her career with her debut film 'Gangster' 14 years ago. Helmed by Anurag Basu, the romantic thriller featured Emraan Hashmi and Shiney Ahuja besides Kangana in the lead roles.

'Gangster' received great appreciation from critics as well as the audiences and also won Kangana the best debut award at Filmfare. Earlier in the day, the team of the 'Fashion' actor marked her 14th anniversary in Bollywood by preparing a video reel of her 14-year-long journey.

Catch up on all the latest entertainment news and gossip here. Also, download the new mid-day Android and iOS apps.

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This story has been sourced from a third party syndicated feed, agencies. Mid-day accepts no responsibility or liability for its dependability, trustworthiness, reliability and data of the text. Mid-day management/mid-day.com reserves the sole right to alter, delete or remove (without notice) the content in its absolute discretion for any reason whatsoever

Allow us to say this but if Hrithik Roshan had a staggering debut with Kaho Naa... Pyaar Hai in 2000, Karishma Tanna made her debut with an equally successful piece of work- Kyunki Saas Bhi Kabhi Bahu Thi. Ekta Kapoor more or less revolutionised the television industry by introducing a concept that was never heard of until it became a dying genre as times passed by.

Talking about Tanna, she didn't have it easy at all, and which actor has. In a chat with Pinkvilla, she candidly spoke about her audition for this iconic show and how it was bad, very bad. "My audition for Balaji was horrible (laughs). I'm generally a good student when learning lines, but in front of the camera, things go haywire. I have fumbled multiple times and it was a very 'ganda' (bad) audition."

She added, "But still, I got chosen. Ekta (Kapoor) ma'am does not see dialogues, she wants the actor to fit in the role, acting is then taken care of. So, I guess I fit the role and that is how I got it." And today, thanks to her success and even the social media sensation, she's known by one and all. She was also seen in Sanju in a special appearance.

Catch up on all the latest entertainment news and gossip here. Also, download the new mid-day Android and iOS apps.

Mid-Day is now on Telegram. Click here to join our channel (@middayinfomedialtd) and stay updated with the latest news

Auditions of MTV Roadies Revolution will be held live on social media for the first time ever, in the wake of the COVID-19 lockdown. This is the 17th season of the popular adventure reality show. "Since its inception, 'Roadies' has had a lot of firsts to its credit. Going virtual is another innovative dimension to its iconic journey and speaks volumes of its repute as a reality show. At a time when social distancing has become the norm of life and we have found respite in our phones, 'Roadies LIVE' auditions is a great effort and a well-timed step to reach the youth. This is also a first for me in 17 seasons and I am looking forward to a power-packed experience. To all the young, high-spirited souls, here's your last chance to make the cut and be a part of this exhilarating journey," show host Rannvijay Singha said.

Starting from Monday (April 27) on the MTV Roadies Facebook page, the first-ever virtual audition will go on up to Friday, and will give one contestant a chance to join the official journey this year.

Neha Dhupia, one of the judges on the show, is excited. "Social media and the euphoria around it is undeniable, more so during this lockdown when we are glued to our phones more than ever. We're excited to bring 'Roadies' to digital platforms that connect the masses. Digital auditions are the best way to tap into the young psyche amidst lockdown and get them prepped up for something challenging. Keeping up with our theme of 'Revolution', I am excited to meet some spirited people during the LIVE auditions who have it in them to take positive action and join us on the journey ahead," she said.

 

 

 

View this post on Instagram

Dare to watch @princenarula & @nikhilchinapa test the wild skills of the entries? Watch it LIVE today at 5 PM on @mtvroadies Facebook page! Also, keep sending in your entries on @voot telling us why you deserve to be on the #RoadiesRevolution journey. Click the link in bio. @oppomobileindia @castrolbiking @axiom_ayurveda @manforceindia #RoadiesLiveAudition

A post shared by MTV Roadies (@mtvroadies) onApr 27, 2020 at 1:28am PDT

 

Added her co-judge Nikhil Chinappa: "Every year, Roadies ups the ante with innovative formats that resonate with the sentiments of the youth. Virtual auditions are a leap ahead in that direction to leverage a platform that is extremely relevant in the present scenario and reach out to a wider demography. 'Roadies' auditions have always called for mass attention and It would be interesting to witness the traction online."

Rapper Raftaar, also a judge on the show, feels "digital has emerged as the new normal" amid the ongoing crisis and lockdown.

"For a show which defines youth, their goals, and preferences, this digital effort can engage the youth and amplify 'Roadies Revolution' in a way never seen before. I am glad to be a part of this one-of-a-kind experience," he said.

Prince Narula, who also judges the reality show, feels "The live auditions are yet another feat in creating a revolution and reaching out to our young audience".

"I'm really excited to meet some brilliant people and look forward to their perspective. This is going to be a great precursor to our adventurous journey later in the year," Prince added.

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The Commissioner of the Philippines Bureau of Internal Revenue, Caesar Dulay, has said the country will introduce a more stringent audit program in 2019, to further improve the tax take.

With everything going digital amid lockdown due to Coronavirus outbreak, reality shows have found a new way to conduct auditions. Madhuri Dixit, Shashank Khaitan, and Tushar Kalia will return as judges for Dance Deewane 3.

For the show, the makers have begun virtual auditions. Madhuri Dixit kicked off her work by recording the promo for the show and asking the audience to participate by uploading their videos oh Viacom18's digital platform.

The final aspirants will be selected for the show once the film and TV bodies resume shoots. Arjun Bijlani will be returning as the show host. They'll kick off the new season after everything goes back to normal.

ALSO READ: Madhuri Dixit and Kajol reminisce about sharing screen space with late Rishi Kapoor

Malaysia's Inland Revenue Board has denied allegations that it is more aggressively pursuing taxpayers affiliated with opposition political parties or their supporters.

EU customs controls are not being applied effectively, an EU audit has found, with importers able to take advantage of loopholes to reduce or evade their duty liabilities.

Company: Resource Access Management Solutions Private Limited
Experience: 7 to 10
location: India
Ref: 24410397
Summary: Company: Global Investment Bank Experience: 7 - 10 Yrs Job Location: Bangalore Key Skills: Compliance Audit Must Have Skills: Compliance Audit INDUSTRY Banking ROLE Senior Manager - NAC Controller ....

The OECD and the United Nations Development Programme (UNDP) have launched a new initiative to help developing countries bolster domestic revenues by strengthening their tax audit capacities.

International tax experts gathered today at the OECD in Paris to share experiences and identify best practices in the implementation of Tax Inspectors Without Borders (TIWB) programmes.

Company: Golden Opportunities Private Limited
Experience: 4 to 8
location: Pune
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Summary: Description Manager/Assistant Manager Internal Audit Job Description: Role incumbent will be responsible for conducting end to end Internal Audit for Indian based clients in the manufacturing Industry. Should be a qualified CA....

Brazil’s supreme audit institution – the Federal Court of Accounts (TCU) – has began a process to reform its audit of the Accounts of the President of the Republic to enhance transparency and accountability of federal budget execution.

OECD signed agreement for a peer review with the Comptroller General of Chile

Brazil’s supreme audit institution – the Federal Court of Accounts (TCU) – has began a process to reform its audit of the Accounts of the President of the Republic to enhance transparency and accountability of federal budget execution.

After three years in development, the International Auditing and Assurance Standards Board (IAASB) has released a set of standards that are game-changing for shareholders and the profession, says PwC.

Master Circular No: 2/2011 - Master Circular on Cost Accounting Records and Cost Audit

On her Instagram Live show Bright Minds, Miley Cyrus, 27, told Hilary Duff, 32, this Wednesday that she only bothered auditioning for Hannah Montana 'to copy you no matter what.'

HECTOR NUNNS AT ALEXANDRA PALACE: Stuart Bingham became the oldest Masters champion on Sunday night in a final dramatically halted by a phantom raspberry-blower.

Speaking to The Mirror on Saturday about the ordeal, the TV personality, 24, said she tried out for Our Girl, but lost out to Michelle Keegan following a car-crash audition.

She stunned the nation 11 years ago when she walked onto the Britain's Got Talent Stage and blew everyone away with her rendition of I Dreamed A Dream.

The 40-year-old coach broke into song to win talented contestant Khalea Lynee, 36, on Tuesday's episode of The Voice, crooning to her until she picked him to be her mentor.

The 43-year-old country star was schooled on emo rock by his fellow coaches on Monday's episode of The Voice after he asked them if it was an actual form of music.

State election officials said Thursday that they're sending the voters' names to the attorney general's office for possible prosecution after an audit found people voted absentee and in person.

She's currently looking for her soulmate in the Love Island Australia villa.

Lonnie Donegan's son is among the first round of hopefuls to take to the stage in the new series of The Voice 2019.

Ronan Keating's daughter Missy has auditioned for The Voice UK.

The hitmaker, 34, was speaking to the judging panel of Tom Jones, Jennifer Hudson and Will.i.am, about the importance of song choice for the show's auditionees.

The singing duo take on Cee Lo Green's 2010 hit Forget You for the nerve-wracking performance on Saturday.

erry Katona's daughter Heidi appears to be following in her mum's showbiz footsteps as she has reportedly auditioning for The Voice Kids over the weekend.

A spoiler clip of her star turn, which will be aired during tomorrow's episode of the show, shows the mother-of-one explain: 'I just wanna show my daughter that you can be whoever you wanna be.'