How to develop a standard approach to complying with the voluntary C-TPAT guidelines?

The U.S. Customs and Border Protection’s (CBP) introduced a major cargo enforcement strategy, the Customs Trade Partnership Against Terrorism (C-TPAT) in November 2001. A voluntary pact between government and business; C-TPAT is an important layer in firming up the international supply chain and increasing border security. It was created out of the realization that it is only the government agency, the CBP, which can provide security for cargo landing in American shores or destined for overseas locations, and that for it to do so, the players in the international supply chain, such as importers, consolidators, carriers, manufacturers, and licensed customs brokers have to work in close cooperation with it.

Based on the Security and Accountability for Every Port Act of 2006; the C-TPAT works by framing agreements with any entity that joins it. This C-TPAT agreement requires such a joining entity to take specific steps aimed at:

  • Protecting the supply chain
  • Identifying security gaps
  • Implementing specific security measures and best practices.

Such an entity -a partner of the C-TPAT -is required to comply with a wide-ranging number of issues relating to the security of the cargo. It has to present details relating to the security of its cargo and should explain what action plans it has put into force aimed at ensuring security for the cargo throughout the supply chain. The C-TPAT certifies entities that have met its requirements. Today, more than 11,000 partners that span a wide variety of business activities work closely with the CBP.

The CBP considers cargo from C-TPAT partners to be of significantly lower risks than non-partners. These cargoes are likely to be given a more relaxed examination at any US port of entry than cargo emanating from a non-C-TPAT partner. This apart, enormous benefits follow from becoming a C-TPAT partner.

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C-TPAT Compliance Strategies

All the dynamics and intricacies of a C-TPAT partnership, the ways of developing a standard for complying with it, as well as the current industry best practices relating to C-TPAT partnership, the strategies by which the cost and complexity of complying with the C-TPAT, and the ways of deriving the full benefits of the C-TPAT program

Strategy, program guidelines and highlights, and ways of ensuring C-TPAT compliance.

A complete overview of the C-TPAT

  • S. Customs and Border Patrol
  • C-TPAT Strategy Design
  • C-TPAT Certification and Benefits
  • International Terrorism as a Challenge
  • Mitigation of Terrorist Threats
  • Mutual Recognition Arrangements
  • Best Industry Practices.

 

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Which is the Best Pathway for Submitting an ANDA for Review and Approval by the US FDA?

A company that wants to manufacture a new drug has to file for a New Drug Application (an “NDA”) with the FDA, which is typically a very expensive and lengthy process, during which the company has to provide umpteen details such as the findings of the clinical research that goes into the development of the new drug, along with filing a patent application at the appropriate stages.

In 1984, the American Congress enacted the Drug Price Competition and Patent Term Restoration Act, or what came to be popularly called the “Hatch-Waxman Act”. The essence of this Act was to fulfil a rather dichotomous aim: to encourage the research and development of new drugs through pharmaceutical research, and to also ensure that the American public had greater ease of access to generic drugs.

Abbreviated New Drug Application1

The latter of these two aims was to basically make sure that the American public would not continue to pay through their nose for drugs, whose exorbitant prices were the result of the pharmaceutical companies factoring in the astronomical cost of research and production -estimated at a whopping $ one billion and more for every new drug, and passing it on to their consumers.

Long drawn-out process of drug approval

A company that wants to manufacture a new drug has to file for a New Drug Application (an “NDA”) with the FDA, which is typically a very expensive and lengthy process, during which the company has to provide umpteen details such as the findings of the clinical research that goes into the development of the new drug, along with filing a patent application at the appropriate stages. More article

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A patent is valid for 20 years, but this tenure doesn’t start from the time the drug is out in the market; rather, it is from the time the pharma company commences its clinical studies. What this means is that the manufacturer loses significant time-which could itself run into anywhere from a few months to a few years- on its patent rights that offer it exclusivity to market its drug, and delays its time to recover the costs of research, production and other factors.

The Hatch-Waxman Act was passed to offer an alternative to this process. It suggests a way by which the manufacturers of drugs can produce a generic pharmaceutical product that does not dilute the bioequivalence of a similar approved drug already in the market, without having to go through the lengthy process. This process, called the Abbreviated New Drug Application (ANDA), requires the manufacturer has to follow the steps needed to satisfy the FDA that the generic product had the bioequivalence of an approved branded drug.

Learning on how to get the ANDA process right

It is to strike a balance between the conflicting needs of the consumer in need of quick access to effective and safe drugs on the one hand, and the regulatory process on the other, that the Hatch-Waxman Act was passed. So, any drug manufacturer has to have a detailed knowledge of the way in which ANDA is formulated

A look at all important guidances and sources

Lamont will offer important guidance on the methods and processes by which applicants have to follow the guidance set out by the FDA. He will explain the requirements set out in the many sources pertaining to the industry, such as the Orange Book, Inactive Ingredient Guide, Active Pharmaceutical Ingredient, Impurity Profile, ICH guidelines, Modules 1, 2,3, and Pharmacopeia.

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The learning areas for manufacturer:

  • Refusal to file or receive
  • cGMP certification or Approved facility
  • Basic QBD issues; Pharmaceutical development reports
  • Drug Master files
  • Inactive ingredients discussion; (Inactive Ingredients Database)
  • Active ingredients; Module 3 recommendation (21 CFR 314.420(a)(2)
  • Drug product manufacturing; bill of materials, batch records instruction (including critical steps)
  • Test specifications; USP, ICH, Certificates of analysis
  • Impurity profile and Stability program.

 

How the Writing of an SOP Procedure Can Have a Positive or Negative Impact on Training

A Standard Operating Procedure (SOP) is a vital document for pharmaceutical organizations, or, for that matter, an organization in any healthcare setting. The SOP is a “look up to” document that describes what steps need to be taken at what time. It is meant to be a guide that people refer to, both to carry out their work, and to go to when they need clarity on a certain step. The intention of writing SOPs is that there should be no confusion or ambiguity when it comes to handling procedures and processes relating to work.

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An effective SOP is one that described the smallest details of a work in a systematic manner and delineates the work to the respective departments and designations. One of the major oversights most organization suffer from is the lack of appreciation of the link between SOP writing and training. It is as important for personnel writing the SOPs to have complete and intricate knowledge of the work for which they are writing SOPs, as it is to impart the right training to employees. Without this vital exercise, the SOP become just a rigid document set in stone.

Right mix of structure and flexibility

When training employees with the understanding and use of SOPs, the personnel training employees on the use of SOPs should ensure that the SOPs have the right blend of structure and flexibility. This flexibility aspect is important because too much rigidity into the SOP can make it ineffective and unsuited to different situations. Why? Because making it adamantine can kill the purpose for which SOPs are written. Employees will not only find it not useless; this rigidity can become a cause for ineffective implementation of work, since it will not give the employees the opportunity to exercise any intuition of their own. Extreme rigidity also makes the document textual and just a piece of legalese and not a living document.

This is just one aspect of SOP training. Personnel in charge of SOP training should keep a host of issues in mind when they train employees about the proper and judicious use of SOPs. This knowledge is the outcome of a very pertinent and valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Get trained on the training aspects of an effective SOP

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Michael Esposito, who has been in the pharmaceutical industry for over 30 years, during which he has gained experience of 17 years in GMP training and document management, will be the expert at this webinar. Michael, who has worked for Wyeth Pharmaceuticals, Pfizer and Johnson & Johnson’s McNeil Consumer Healthcare Division in a variety of areas including Packaging, project administration, Quality Assurance, Government Contracts, translations, systems training, and international operations, will offer a total understanding of how to organize effective trainings for SOP.

Training is the core of SOPs

Michael will explain the importance of writing a good SOP that fulfills its purpose and will show how to train employees in the right manner on the use of SOPs. The training should impart knowledge in such a manner that users remember it and know how to apply it at different situations. The training should not be just a set of “hand me downs” that will read out what is written in it. If this is how the training is structured, there is no need for it, because employees can do this themselves.

The training should meet the desired learning objectives. It should explain roles and functions and methods of carrying out work in a clear way. The way it sets out responsibilities for different roles is very important, because ambiguity can lead to confusion and contribute to the ineffectiveness of the document. It will result in the SOP being handled by too many people, adding to the ambivalence.  It should also have clarity on the curricula it sets out.

Michael will give clarity on the role of training in SOPs. The learning objectives he seeks to achieve with this session include:

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ARTICLES BY MICHAEL ESPOSITO

Understanding Regulatory Expectations for Diversity in Clinical Trials

Diversity of the subjects that are part of a clinical trial is a very important dynamic in the study. This is because ethnicity and genetics, along with age, gender and lifestyle, are among the factors that determine our response to medicine.

Diversity of the subjects that are part of a clinical trial is a very important dynamic in the study. This is because ethnicity and genetics, along with age, gender and lifestyle, are among the factors that determine our response to medicine.

Despite the US having one of the most diverse collection of ethnicities and the fact that nearly three in every four Americans are willing to be a subject of a clinical trial if the physician assented to it; it is a historic fact that minorities have consistently been underrepresented at clinical trials. Ironically, it has been known since at least a century that individual vary in their response to medication.

Diversity is a factor in the effectiveness of a clinical trial

Diversity in Clinical Trials1

A proper and judicious mix of the ethnic groups makes the clinical study well represented, well-rounded and diverse, leading to a higher level of effectiveness. A clinical trial in which there is heavy representation of only one or a handful of ethnic groups is not a complete representation of the effects of a drug, medical device or any other product that the trial seeks to produce.

The FDA has taken note of this fact, and for over two decades, has been issuing guidances to the industry to make clinical trials more inclusive. It has issued many directives on the age, gender and ethnic composition of the trials. The FDA Safety and Innovation Act (FDASIA 907) that the American Congress passed in 2012 required the FDA to not only report on the diversity of the subjects of a clinical trial, but also on the quality of the outcomes, meaning the extent to which ethnicity, age and sex of the patient determined the outcomes.

Accordingly, asked to produce an action plan in this regard, the FDA released the Action Plan to Enhance the Collection and Availability of Subgroup Data in 2014. This plan consisted of many as 27 recommendations for addressing the diversity aspect of clinical trials.

Get to understand the dynamics of diversity in clinical trials

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So, organizations carrying out a clinical trial have to comply with all these and other existing regulatory requirements relating to the diversity element of these trials. How do they understand these regulatory requirements, and what do they need to do to be compliant? This is the learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.

This webinar is being organized to offer complete understanding of this very vital aspect of clinical trials. As we have seen, a clinical trial at which the subjects are of a diverse makeup is considered more reflective in determining the outcome of the research. A clinical trial that does not have the recommended mix in the diversity of its subjects is not likely to produce optimal result. The consequence of this gap is that the program could be imperiled, leading to inferior or subpar findings.

Lauren Neighbours, Head of Regulatory Affairs, North America at PSI, will be the speaker at this very valuable webinar. Dr. Neighbours leads regulatory strategy at her organization in the US and Canada. Dr. Neighbours has over 10 years of scientific research experience within industry, government, and academic settings. Also having experience in coordinating and overseeing the strategy and operations of full-service Phase 1-4 clinical studies spanning many therapeutic areas and product types; Dr. Neighbours has authored a variety of clinical and regulatory documents, and has contributed as an author to multiple IND/CTA and marketing application dossiers.

Dr. Neighbours will offer clarity into the current regulatory landscape surrounding diversity inclusion in clinical trials. She will show how organizations can adapt their clinical study designs to comply with regulatory agency expectations and achieve success at their program. During the course of this webinar, Dr. Neighbours will cover the following areas:

  • FDA and other regulatory authority guidance on diversity of clinical trial participants
  • Current trends on clinical trial participation by patient demographic
  • Best practices on developing clinical studies to meet regulatory expectations
  • Resources on diversity inclusion in clinical trials.

Stephen Hawking’s secret to surviving his terrible condition

Hawking replied from his wheelchair, his lips bending up into a slight smile. “And also a universe where you’re funny.

The late-night comic had found his perfect straight man. In June 2014, John Oliver sat down with renowned theoretical physicist Stephen W. Hawking for an interview.

“You’ve stated that there could be an infinite number of parallel universes,” the host of HBO’s “Last Week Tonight,” asked Hawking. “Does that mean there’s a universe out there where I am smarter than you?”

“Yes,” Hawking replied from his wheelchair, his lips bending up into a slight smile. “And also a universe where you’re funny.”

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Hawking died early Wednesday at his home in England at the age of 76. Throughout his career as one of the world’s most recognizable cosmic thinkers, he regularly threw himself into pop culture’s comedic ring with cameos on programs such as “The Simpsons” and “Late Night with Conan O’Brien.”

These appearances aligned with a plucky wit that defined Hawking’s personal life as much as his universe-shaking theoretical work. Humor, however, was not just one side of his personality, but a key to overcoming the degenerative motor neuron disease he struggled against since 1963.

“Keeping an active mind has been vital to my survival, as has maintaining a sense of humor,” Hawking said in a 2013 documentary. “I am probably better known for my appearances on ‘The Simpsons’ and on “The Big Bang Theory” than I am for my scientific discoveries.”

That humor was deployed against a terrible prognosis.

At 21, Hawking was diagnosed with a condition similar to amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease. According to the ALS Association, “Half of all people affected with ALS live at least three or more years after diagnosis. Twenty percent live five years or more; up to ten percent will live more than ten years.”

The disease would eventually shut down Hawking’s motor functions, rendering him speechless and unable to move without a wheelchair. Doctors initially said he would be dead in two years. His condition, however, proved to be a rare slow-acting version.

But Hawking fought through his deteriorating physical state, rising to a position as a celebrated professor of mathematics at the University of Cambridge and altering the popular conception of physics with his 1988 bestseller, “A Brief History of Time.”

To Continue his story http://snip.ly/c2mff

Rare lunar eclipse offers glimpse of “super blue moon”

A blue moon happens on average just under every three years.

Many parts of the globe may catch a glimpse Wednesday of a giant crimson moon, thanks to a rare lunar trifecta that combines a blue moon, a super moon and a total eclipse.

The spectacle, which NASA has coined a “super blue moon,” will grace the pre-dawn skies in the western United States, as the moon crosses into the shadow of the Earth and turns blood red.

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“Weather permitting, the West Coast, Alaska and Hawaii will have a spectacular view of totality from start to finish,” said Gordon Johnston, a lunar expert at NASA.

Other parts of the world, including Australia and Asia, will see it at night, as the moon comes up in the west.

“The last time a complete lunar cover-up took place on the second full Moon of the month was December 30, 1982, at least as reckoned by local time in Europe, Africa, and western Asia—locations where the event could be seen,” said Sky and Telescope magazine.

“The last ‘‘ total lunar eclipse visible from the US and North America happened on March 31, 1866.”

The “blue moon” aspect simply means it is the second full moon in a month, not that the moon will appear blue. A blue moon happens on average just under every three years.

It’s called a super moon because the moon, in its elliptical orbit, is near its closest point to Earth.

This proximity, or perigee, makes it appear 14 percent bigger than normal and 30 percent brighter.

The reddish tint—or blood moon—happens due to “the effect of all the sunrises and sunsets all around the planet reflecting off the moon, which I think is really lovely,” said NASA astrophysicist Michelle Thaller.

Sunrises and sunsets appear pink, red and orange because of the long distance light must travel, causing light waves to bounce in different ways, explained Thaller.

“The reason a sunrise or a sunset is red is the sunlight has to pass through a large amount of air on the side of the Earth and that actually scatters away any blue light and just lets the red light come on through,” she said.

Enhanced here how to watch http://snip.ly/np9o8

5 Ways to Maintain a Clean Eating Lifestyle During the Busy Holiday Season

Sometimes, we all just need a little inspiration to stay on-track to eat healthy meals, especially when life gets busy. With the holidays around the corner, consumers are surrounded by more opportunities to eat decadent dinners and indulgent party appetizers. That’s why the Just BARE® chicken brand, known for raising goodness by providing good food for more people, launched its Living Lean & Clean campaign.

Experience the interactive Multichannel News Release here:

https://www.multivu.com/players/English/8189351-just-bare-chicken-recipes-monique-volz/

Clean Eating Recipes

Featuring clean eating inspiration from Monique Volz, a health and wellness blogger and founder of Ambitious Kitchen, the Just BARE campaign offers consumers recipes for quick meals at JustBareChicken.com/Recipes.

“Whenever I’m the busiest I know I’m doing a mix of all of the things I love, but it’s important to keep your body on track and maintain a healthy lifestyle,” says Volz. “Avoiding processed food and making your own chicken salads are a great way to live lean and clean and also save money.”

Two good food decisions for this holiday season are recipes like Greek Salad and Thai Peanut Chicken Quinoa Salad. Both salads feature clean ingredients, such as fresh salad greens and chicken raised with no antibiotics-ever, that you can customize and layer into portable, glass jars—perfect for taking to work or eating between holiday shopping extravaganzas.

How to Eat Healthy On-the-Go

As life gets busy before the new year, Just BARE offers these five tips to develop and maintain good lean and clean habits:

Eat High-Quality Food: Clean eating is a great way to live a healthy lifestyle. It means making meals featuring ingredients that are fresh, all natural or organic.

Choose Healthy Snacks: Don’t let between-meal treats spoil your routine. Strive to have healthy snacks on-hand, like Chicken Roll-ups.

Don’t Skip Meals—Ever! Carve out time for meals, even on the busiest of days. Missing breakfast, lunch or dinner sets you up to be hungry, which can make it harder to avoid bad food choices.

Simplify Meal Prep: Make-ahead recipes, like Bento Boxes, ensure you always have rich, nutritional options, even when you’re on-the-go.

Add Flavor to Low-fat Protein: Protein can help you stay full longer and adding bold flavors to lean protein like chicken makes it as good for you as it is to eat.

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