Significance of Food Recall

Plenty of control measures are being taken by food manufacturers to ensure product safety. Sometimes there are some adverse situations wherein a product manufactured and sold in the market is defective and some people fall sick or get injured, or is not in compliance with the legislation. In such a situation when a problem product has left the control of the manufacturer, it must be removed from the market or recalled.

The concern for food safety to your customers and employees must be a constant focus for all operators in the system. Ultimately, how well your company manages the crisis situations will make significant difference in how your company brand is perceived in the public's eyes and how well it succeeds in today's highly competitive marketplace. Most importantly failure to ensure food safety can jeopardize the health of your customers and could be detrimental to your business and reputation.

To understand why your company should have a crisis management plan, why having an effective product recall is critical in your company, FDA Food Safety Modernization Act, how to develop an effective crisis management program for food recall attend this webinar by Angeline Benjamin “Planning and Conducting an Effective Food Recall” Angeline Benjamin is the president of B&B Food Safety Solutions, a food safety consulting firm. She has been in the quality assurance and food safety businesses for over 30 years. Angeline began her quality assurance career at Hunt-Wesson Foods. http://www.onlinecompliancepanel.com/webinar/EffectiveFoodRecall-501024/OCT-2015-SM

Common HMDA Reporting Requirements and Mitigation Steps

The Home Mortgage Disclosure Act (HMDA) demands covered institutions to make loan information readily available to the public. Public, industry leaders and the regulators rely on this data to analyze the performance of mortgage lenders in achieving goals that are achieved under the Equal credit Opportunity Act and the Fair Housing Act and the Community Reinvestment act. Incorrect HMDA data hurdles efforts to track discriminatory patterns that might exist in home mortgage lending and other compliance violations.

The major four errors in HMDA reporting are as follows. Errors in recording any one of these three variables will give incorrect calculations.

• Failure to Capture All HMDA-Reportable Transactions
• Inaccurate Loan Amount
• Incorrect Geocoding
• Wrong Rate Spread Calculation

Some of these mistakes are considered more significant than others. Some are more common than others. If the number of mistakes is high, it can result in rework and even fines. This can lead to loss of trust in your institution by regulators, which is never a good thing.

To learn the significance of HMDA reports, common mistakes in HMDA reports and how to reduce errors attend this webinar http://www.onlinecompliancepanel.com/webinar/HMDA-ReportingMistakes-501070/OCT-2015-SM

Differences between Device and Drug Regulation

Differences between Device and Drug Regulation

http://www.onlinecompliancepanel.com/webinar/DeviceAndDrugResearch-501007/OCT-2015-SM

Here are a few definitions: Clinical investigation is nothing but an investigation involving a test article and one or more than one human subjects.

A Drug is known as a substance recognized by an official pharmacopoeia or formulary. Drug is a substance used in diagnosis, treatments or prevention of a disease.

An investigational Drug means a new drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.

Research Involving Drugs Exempt from IND Requirements: Research Involving Drugs Exempt from IND Requirements means a clinical research of a marketed drug (i.e, an FDA-approved drug) is exempt from the IND requirements if every criteria for exemption are truly met: The drug product is marketed in the United States lawfully; the investigation is not planned to be reported to the FDA as a well-controlled study supporting a new indication and there is no intent to use it to support any other major change in the labeling of the drug. As per the Investigational Device Exemption regulations there are three types of device investigations: Exempt Device Studies, Non-significant Risk (NSR) Device Studies and Significant Risk (SR) Device Studies.

Clinical Investigation: The term Clinical Investigation refers to any research involving one or more than one subjects to determine the safety and effectiveness of a device.

http://www.onlinecompliancepanel.com/webinar/DeviceAndDrugResearch-501007/OCT-2015-SMThis webinar will discuss the differences between device and drug clinical research and the current regulations governing the use of drugs and devices in a clinical study.

Orphan Drug Act

http://bit.ly/ClinicalResearchStudies 

Rare diseases (RDs) are significant public-health issue and they pose a challenge to the medical community. These rare diseases are called ‘health orphans’, because research and developments have neglected them for years due to many RED challenges. Amendments were made to the existing law in the 1960s, mandating that every drug must be proven to be safe and effective through ‘adequate and well-controlled studies’ before getting market approval. Then raising drug development cost ended in drugs for small disease populations being ‘orphaned’ by many top drug companies.

Congressional Findings for the Orphan Drug Act

(1) There are many diseases and conditions, such as Myoclonus, Huntington's disease, ALS (Lou Gehrig's disease), muscular dystrophy and Tourette syndrome, which affect a few individuals residing in the United States that the diseases and conditions are regarded as rare in the United States

(2) Satisfactory number of drugs for treatment of many of such diseases and conditions has not been developed

(3) Drugs for such diseases and conditions are generally referred to as "orphan drugs"

(4) Because very few individuals are affected by such rare diseases or conditions, a pharmaceutical company which develops an orphan drug may expect the drug to generate moderately small sales when compared with the cost of developing the drug and consequently to incur a financial loss

(5) There is reason to believe that some promising orphan drugs will not be developed unless changes are made in the applicable Federal laws to reduce the costs of developing such drugs and to provide financial incentives to develop such drugs; and it is in the public interest to provide such changes and incentives for the development of orphan drugs.

The Orphan Drug Act began many years ago and now, many believe that this is not the best use of resources. Attend the webinar “Orphan Drugs: The Conundrum” by Marybeth Regan, to learn more about the topic.

State-Wise Rules on Mail Order Pharmacy in the USA

http://bit.ly/PharmaRegulatoryCompliance 

Many pharmacies are developing and expanding compounding practices. Based on the uniqueness of the practice, these pharmacies can increase earnings substantially by developing a mail order component and marketing their practice to patients in other states. This program would serve as a guide to enable these pharmacies to expand into mail order. 

Here are the state-wise rules on Mail Order Pharmacy in the USA.

California and Texas

California and Texas require nonresident pharmacies to register with the regulatory board, but do not require them to submit prescription data. 

Georgia and Pennsylvania

Georgia and Pennsylvania neither require nonresident pharmacies to submit prescription data nor dothey require them to be licensed to do business in the state.

Nebraska and Wisconsin

Nebraska and Wisconsin require nonresident pharmacies to be licensed, permitted and/or registered in their state; however, neither Nebraska nor Wisconsin has regulations in place at this time regarding submission of PMP data.

Massachusetts

Massachusetts requires nonresident pharmacies to submit prescription information to the state PMP by rule.  However, there is no corresponding requirement for a nonresident pharmacy to be licensed, registered or permitted by the regulatory board.  Therefore, the Massachusetts PMP has no authority to require nonresident pharmacies to report prescription data.

Alabama

Alabama law requires every mail-order house (also known as a “nonresident pharmacy”)located outside of Alabamathatdispenses drugs or medicines to anywhere inside the state of Alabama obtain a permit from the State Board of Pharmacy.  Alabama regulation requires that every nonresident pharmacy comply with all statutory and regulatory requirements for controlled substances

New Jersey

All pharmacies permitted by the New Jersey Board of Pharmacy are required to submit information about controlled substance prescriptions to the state PMP.  All nonresident pharmacies that ship, mail, distribute or deliver in any manner into the state of New Jersey are required to be registered with the board.

New Mexico

The New Mexico Board of Pharmacy shall monitor the dispensing of all Schedule II, III, IV and V controlled substances by all pharmacies licensed to dispense such substances to patients in the state of New Mexico.  No nonresident pharmacy shall ship, mail or deliver prescription drugs to a patient in New Mexico unless it is first licensed by the Board. 

Washington

Nonresident pharmacies located outside of Washington that ship, mail, or deliver, in any manner, controlled substances, legend drugs, or devices into Washington must be licensed by the department of health and must submit all transactions involving patients with a Washington zip code to the PMP.

http://bit.ly/PharmaRegulatoryCompliance Attend this webinar to know more on the advantages and pitfalls for pharmacy and pharmacist licensure in other states.

Why do you need to use Indemnification Clauses?

Indemnification is a contractual obligation by one party to pay or compensate for the loss or damage example one of your careless consultants leaves certain equipment on the ground causing a visitor to trip over it and injures himself/herself. The visitor sues you because the accident occurred on your office premises. What will you do? If there was an indemnification clause in the contract between you and your consultant, you can seek the consultant to reimburse the amount that you had to pay to the injured. This clearly explains how you can shift the responsibility for payment to the concerned party who caused the injury.

or liability incurred by another party to the contract or by some third person. For

Indemnity is not necessarily limited to personal injuries or property damage. It can also apply to contractual obligations.

Register for the webinar by Kenneth A. Sprang  “IndemnificationClauses: Protecting your Company When Drafting Contracts” to understand significance of the clause deeper.

Health Care Marketing Program

Marketing is one amongst the least understood functions in mainstream health care. This is part as a result of the necessity to vie within the public forum is new to the trade, part as a result of the mediums and technologies have dramatically modified and part as a result of there are so few experienced people with combined trade, technology and marketing experience.

Why is marketing so vital now? 3 reasons: 

Medical technology has created outcomes a lot of consistent and also the internet has created patients a lot of educated; High insurance deductibles drive increasing consumerism wherever eight of 10 people currently choose their suppliers mistreatment search engines, and eight of 10 of them use Google and Service, convenience and perceived value are on par, and will shortly succeed, delivering sensible clinical outcomes, that are currently generically expected.

Competing effectively, and dominating your specialty, is increasingly vital as a result of the current delivery and compensation system is financially unsustainable. those who fail to adapt can possible fail to survive. Size goes to matter because there are crucial efficiencies in scale and volume which will build the distinction.

Marketing is an investment that brings massive returns with the correct partner, and prices dearly with the incorrect one. selling isn't a website, search engine optimization or marketing, advertising, hoarding or pamphlet though plenty of purveyors of these services want you to think thus. Those are simply techniques to support ways that are driven and changed by applied math analysis - which takes experience, deep understanding of the health provision system and knowledge. As Thomas Edison once magnificently aforesaid regarding invention, selling is "99% perspiration and one hundred and twenty fifth inspiration."

Marketing is knowing wherever the competition is vulnerable and wherever you're robust, becoming excellent at the former and higher at the latter - and adapting. it's understanding what the term "patient experience" extremely means and delivering superior service with consistency, competency and a smile. It's hiring people who match your culture, and basing your culture on excellence, clinically, social control and service-wise. it's setting clear goals supported by skilled strategic designing, determinant the simplest combination of techniques and mensuration the results.

It is straightforward for marketers to create claims, thus however does one understand what you're obtaining is working? you cannot fix what you cannot live, and you do not understand what desires fixing while not knowing however it should perform. Our recommendation - follow the money.

When we have a tendency to place during a dollar, expect it to come back ten in revenue at intervals an inexpensive amount of your time. We have a tendency to live output perpetually, calibrate for accuracy and regulate for optimum performance. Once mistreatment solely 2 or 3 techniques without an overall strategy, we have a tendency to expect a come back of 5 to at least one.

Most vendors, particularly advertisers, website developers and search engine optimization professionals, tout their ability to drive traffic, the best metric to attain.

The hard part is to drive quality inquiries, capture and convert them into patients, retain them as patients and earn their referrals. that's what marketers do - and that they count the money, not simply the cars.

Investing during a comprehensive selling program isn't creating a bet; it's stacking the deck, taking part in a full hand and investigation the cards. A comprehensive, expertly managed marketing program can deliver, maintain dominance and secure your future. Check out this link for more knowledge Effective and Compliant Health Care Marketing Program