What are Suspicious Activity Reports and Who Should File ?

The BSA also requires every US national bank to file a Suspicious Activity Report (SAR) when they detect certain known or suspected violations of federal law or suspicious transactions related to a money laundering activity or a violation of the BSA. A SAR filing is required for any potential crimes:

-          involving insider abuse regardless of the dollar amount;

-          where there is an identifiable suspect and the transaction involves $5,000 or more; and

-          where there is no identifiable suspect and the transaction involves $25,000 or more

An SAR filing also is required in the case of suspicious activity that is indicative of potential money laundering or BSA violations and the transaction involves $5,000 or more. A customer must not be informed that an SAR related to his transactions is being filed.

In the BSA/SAR context, a “transaction” includes any of the following:

-          a deposit

-          a withdrawal

-          a transfer between accounts;

-          an exchange of currency;

-          an extension of credit;

-          a purchase or sale of any stock, bond, certificate of deposit, or other monetary instrument or investment security; or

-          any other payment, transfer, or delivery by, through, or to a bank

The law requires the following institutions to file SARs:

-          Depository institutions

-          Money Service Businesses (MSBs)

-          Casinos and card clubs

-          Securities and futures industries

-          Insurance companies

-          Mutual fund operators

Schedule of Penalties by OSHA

Typically when an employer has violated any rules or standards related to OSHA , OSHA sends a citation and proposed penalty by registered email and it is must for the employer to put the copy of citation at the place of violation for at least 3 days or until the violation is rectified.

Below are few examples of violations and the penalties associated with it.

Other-Than-Serious Violation — A violation that has a direct relationship to job safety and health, but probably

Minimum: $0 / Maximum: $1,000

Serious Violation Minimum: $1,500 / Maximum: $7,000

Willful Violation Minimum: $5,000 / Maximum: $70,000

Willful Violation (results in death) Individuals: $250,000 + 6 months jail / Corporation: $500,000 + 6 months jail

Willful Violation – Egregious Multiplier Willful penalties are applied on a violation-by violation basis or employee by employee exposure.

Repeat Violation Maximum: $70,000

Failure-to-Abate Up to $7,000 a day for each day violation continues beyond abatement date

Falsifying records or making false statements $10,000 fine or up to 6 months jail or both

Violating Posting Requirements (failure to post OSHA poster, OSHA 300 Annual summary, citations, etc) Maximum: $7,000

Failure to report fatality/catastrophic event within 8 Hours Minimum: $5,000

Providing advance notice of inspection $1,000 fine or up to 6 months jail or both

FDA warning Indian drug manufacturing units - Is it a retaliation to court ruling against Novartis

One after other drug manufacturing units of India getting warning letters or getting banned to manufacture licenses getting cancelled. Is this a systematic fight back (to the set back of patent disputes in favor of local generic manufacturers)  by big pharma by their arm twisting techniques or is it real the plants are not following procedures.

Today Hospira's manufacturing unit in India received a warning letter from FDA concerning the drug safety i.e contamination of drugs manufactured at its facility in India.

Indian pharmaceutical companies have also recently come under the FDA's scrutiny after generic drugmakers Ranbaxy Laboratories and Wockhardt Ltd faced issues related to manufacturing practices. Incidentally Indian court's ruling against Novartis came in April and after that FDA is finding issues and issuing warning letters. Or is it simply they have not followed the procedures.


Ranbaxy earlier this month agreed to pay $500 million in civil and criminal fines under a settlement agreement with the U.S. Department of Justice, after it pleaded guilty to three felony counts related to the manufacture of drugs at two Indian locations.

The FDA imposed an "import alert" on a plant operated by Wockhardt in the western state of Maharashtra on May 22.


As in the case of Hospira plant which is bought by Hospira from India-based Orchid Chemicals & Pharmaceuticals Ltd , the FDA said it found that surfaces in the facility were not always sanitized prior to use and that sterile drug products were not protected from contamination

Selecting medical device interconnects

Technology advances in electronic consumer devices and the telecommunications industry are converging at a rapid rate with medical device technology. For example, the medical industry now embraces membrane switches from the appliance industry and relies on mobile phone interconnects within portable medical monitoring devices. In addition, super-precise surgical tools have been further improved by combining advanced fiber optic and interconnect design technologies

In this article published in http://www.eetimes.com there is a detailed explanation on this subject . click here to read full

Top 10 risks and opportunities for global organizations. Published by E&Y.

1. Regulation and compliance
2. Cost cutting
3. Managing talent
4. Pricing pressure
5. Emerging technologies
6. Market risks
7. Expansion of government's role
8. Slow recovery/double-dip recession
9. Social acceptance risk/CSR
10. Access to credit

In this report,  the global top 10 business risks and opportunities emerging from it is explored. As in previous years, it has been taken a “bottom-up” approach to the work, gathering opinions from leading industry-based and academic commentators, across seven global sector groups.

This comprised a large-sample survey of companies and governments in 15 countries in order to rank the risks and opportunities, obtain forecasts on whether these challenges would be more or less important in 2013, and discover how leading organizations in each of the seven sectors are responding to these challenges.

The research suggests that regulation and compliance continues to be the biggest overall risk. In fact, four out of the seven sectors we surveyed ranked this as number ranking, although many respondents indicated steps taken to mitigate these risks have been reasonably effective. 

With regard to opportunities, improving execution of strategy across business functions was ranked number one overall. Looking across the sectors, the impact of this opportunity is uniformly high in all cases. Investing in processes, tools and training to achieve greater productivity was ranked second overall. However, individual sectors and countries vary widely in the relative importance they give to this opportunity

Read The full report

Top 5 global risks of 2013 - World Economic forum

In a report published by global economic forum the top five risks for 2013 are

1. Severe income disparity
2. Chronic scal imbalances
3. Rising greenhouse gas emissions
4. Water supply crises
5. Mismanagement of population ageing

The top 5 impacts due to these risks are 

1. Major systemic fi nancial failure
2. Water supply crises
3. Chronic scal imbalances
4. Failure of climate change adaptation
5. Di usion of weapons of mass destruction

The World Economic Forum’s Global Risks 2013 report is developed from an annual survey of over 1,000 experts from industry, government, academia and civil society who were asked to review a landscape of 50 

global risks.

The global risk that respondents rated most likely to manifest over the next 10 years is severe income disparity, while the risk rated as having the highest impact if it were to manifest is major systemic financial failure. There are also two risks appearing in the top five of both impact and likelihood – chronic fiscal 

imbalances and water supply crisis.

Read The full Report

Major Risks of 2013

In an article published by www.boardmember.com below are the major risks of 2013 as assessed by corporate leaders by a survey sought the views of more than 200 board members and C-level executives across a wide variety of industries about the risks their organizations expect to face in 2013. Participants were asked to rate a list of 20 risk issues on a scale of one to 10, with one indicating "no impact" and 10 indicating "extensive impact."

According to the survey results, the top 10 risks rated as having the greatest impact in 2013 are

Device Tax Could Cost Almost 150,000 jobs

As per http://www.mddionline.com/blog/devicetalk/device-tax-could-cost-almost-150000-jobs-says-conservative-economist

Diana Furchtgott-Roth told the Energy and Commerce Committee today that the device tax will stifle innovation and push production overseas, to the tune of 146,000 jobs. 

The Washington Examiner reports on Furchtgott-Roth's testimony, saying "the tiny provision in Obamacare that puts a 2.3 percent tax on 'medical devices' such as heart valves, insulin pumps and dental fillings will stifle development of the devices and push production overseas since no other country taxes the items." 

I'm not sure if Furchgott-Roth said that "no other country taxes the items," or if that is a misread by the Washington Examiner reporter. Those of us who've been following the device tax know that it has nothing to do with where the device is manufactured—it has to do with where the devices are sold. However more than one expert has said that to alleviate the cost burden of the tax, medical device companies will look overseas for cost-effective means of production. 

The question is, how many jobs would it cost? 

Furchtgott-Roth predicted a 10% shift in production overseas that would cost up to 64,000 jobs and a 30% shift would cost up to 146,000 jobs.  

If those numbers are correct, we have a bigger story to tell for repeal efforts. 

FDA 2012 and 2013 acceptances vs denials - hot pursuit

Although the number of new drugs approved by the U.S. Food and Drug Administration (FDA) rose to a 15-year high last year, there have been several high-profile denials so far in 2013, according to a recent announcement made by the regulatory agency. 

 

 

The FDA approved a total of 35 novel drugs in 2012. In the last decade, the FDA averaged about 23 approvals per year. According to many analysts, these approvals are likely to increase with the passage of the Prescription Drug User Fee Act (PDUFA). 

The 35 new drugs approved last year included a groundbreaking treatment for a form of cystic fibrosis, the first human cord blood product ever approved and the first drugs to treat advanced basal cell carcinoma—a form of the most common skin cancer—and the bone marrow disease myelofibrosis. 

 

Read full story http://www.drugdiscoverynews.com/index.php?newsarticle=7142

Compliance 5 years before and 5 years after

Different people might have different opinions about the changes in Compliance happened in last 5 years. But the basic thing that has happened is govt's has formulated new rules and companies are trying to adhere more and they have ways to do it and more and more tool and techniques has come to the forefront. Earlier companies were thinking that it is mandatory to pay fines and get caught in the legal battles and hence used to put some amount of money as bad debt to pay these fines but now with better education and knowledge sharing they are looking to overcome the compliance hurdle. Now they are thinking about cost of no-compliance vs cost of compliance i.e what they have to pay as fine vs what they can pay to create compliant organization.

This is more and more going to be prominent in the next five years with the advent of more and more vendors and tools the real time monitoring and assessment becomes possible and hence the frequency of assessment has gone down and companies are looking for Real-time assessments and measurements.  New technologies for capturing data, analyzing the data and monitoring compliance risks on a real-time basis will supplement  the existing techniques for monitoring compliance program performance. Overall companies are looking for a single platform based compliance where all areas of corporate compliance is connected and the compliance officer can have a holistic view to control all..

Types of DMF (Drug Master File)

The types of DMFs are:

• Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
• Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
• Type III Packaging Material
• Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
• Type V FDA Accepted Reference Information

As per geography -

EU DMF 

• Active Substance Master File (ASMF) procedure, commonly known as the European Drug Master File 
• EU Authority (EMEA) does not give DMF number.
• If the API is in EU Pharmacopoeia, EMEA can accept EDMF filing and issue a “Certificate of Suitability” for it.
• If the API is not in EU, EMEA would not accept DMF filing alone. 
• The EDMF procedure can be used for the following active substances, including herbal active substances/preparations (except biological active substances,), i.e.: New active substances 
• Existing active substances not included in the European Pharmacopoeia (Ph. Eur.) or the pharmacopoeia of an EU Member State 
• Pharmacopoeial active substances included in the Ph. Eur. or in the pharmacopoeia of an EU Member State 

Canada DMF

A Canadian DMF, like a DMF submitted to the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER), is a submission that may be used to provide detailed information about facilities, processes, or articles used in the manufacture, processing, packaging, and storage of human drug products. 

Australia DMF

Where a drug substance used in the manufacture of a medicine is sourced from a third party 

manufacturer, data on its manufacture, quality control and stability may be submitted via a Drug Master File (DMF). The relevant European guidelines for the European Drug Master File Procedure, which has been adopted by the Therapeutic Goods Administration (TGA), are available from the TGA web site1. 

A DMF using the United States format is acceptable if a DMF formatted according to the Common Technical Document (CTD) or the older European format is not available.

Details of DMF - 

US http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm

Canada:

http://www.hc-sc.gc.ca/dhp-mps/prodpharma/fees-frais/dmfcost_fmmfrais_e.html

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/edqm_2007_e.pdf

EU:

http://www.emea.europa.eu/pdfs/human/qwp/013402en.pdf

Australia:

http://www.tga.gov.au/pdf/pm-argpm-ap11.pdf

Guidelines to follow while firing - avoid counterproductively

1. It should be the last option not a option. We should be very careful and should have series of performance discussions actions, documentations and efforts to make it work
2. Be prepared for the nitty gritty of answering right to the questions which might come across in a firing meeting.  When is the official end date? Are there severance arrangements? Are there opportunities elsewhere in the company? Is career counseling available? What happens with benefits? You may need help from HR to make sure that these answers are available.
3. At the meeting be ready to listen but not react. Listen with respect and then direct the person towards the practical realities of moving on. Offer to talk again later when the emotions are not so raw, or ask a trained HR counselor to join you.
4. After the firing, talk to your team about the process, the reasoning, and the implications for them (within the limits of confidentiality).
5. Do not avoid facing your team and talking about reality as it is.

Related Training - 

Effective Discipline and Lawsuit-Proof Termination: How to Remedy Performance and Conduct Problems While Minimizing Your Legal Risks

Hitech Tip Jars - loss benefit analysis for workers

As many people are doing online ordering and credit card payments, it becomes obvious they do not leave aside something as tip as the average size of day today transactions in coffee shops are around  $10-$20. So the workers tend to lose on their tips. So have it not stop now an advanced hitech tip jar is introduced where customers can pay tip by swiping their card , but will not get receipt and it is unaccounted transaction. An old-fashioned cash-register chime alerts them that the transaction has gone through, but there is no receipt. Counter workers later divvy up the proceeds, which right now are not subject to a processing fee.

In this way though people do not use coins to tip but now they can tip through this machine. Some of the jobs depend on tips to make a good days earnings and with no tips these jobs lose attractiveness.

What most restaurant-goers don't realize is that when they tip on plastic, management will often deduct a portion, usually for processing fees, before distributing the money to servers on a weekly or monthly basis. State law in New York and several other states prohibits management from taking any part of tips for any reason.
Baristas, on the other hand, don't work for tips. By law they make at least minimum wage. At major coffee houses like Starbucks, they may also qualify for health benefits.

Technology, of course, isn't always a solution. When Swork Coffee in Los Angeles recently swapped paper receipts for an iPad checkout system at its three locations, tips dropped more than 25 percent overnight, the workers  who make between $9 and $12 per hour, could once count on $50 in tips per shift, but now sometimes make less than $5.

Is compliance with standards and regulation an obstacle

Are you worried about Compliance. are following things bothering you.
What i should know about compliance ?
what areas affect my company ?
What i have to do when ?
What is requied as a compliance professional to grow professionally?
Where to go to find resources ?
This blog tries to answer above things.