Tag Archives: FDA

Vitamin Companies – Ask Your Contract Dietary supplement Manufacturer These three Inquiries About G

If you’re a small , you deal with a whole new set of issues starting this June. On June 25, smaller supplement and vitamin companies join large and medium sized organizations in staying necessary to meet the FDA’s current very good production practices (GMPs).

These GMPs are basically a long time coming. When it was handed in 1994, the Dietary Dietary supplement and Overall health Training Act (DSHEA) required that the FDA set up and enforcing GMPs. But it wasn’t right up until 13 years later on, in 2007, that the FDA eventually itemized them. In 2008 the FDA began enforcing them with big manufacturers, followed by medium-sized makers in 2009.09.

Now, it’s your flip.

For Modest , GMPs Provide Positive aspects As Properly As Difficulties

Even though to some extent these regulations may possibly look onerous, they basically are a boon to an sector challenged by uneven criteria and the client mistrust that comes with it. For this explanation, numerous companies have welcomed the enforcement of these very long overdue rules. Industry gurus predict that the enforcement of GMPs will increase the industry’s picture and boost the by now continuous industry progress for nutritional supplements.

Nonetheless, earning certain you survive this challenging yr could require some significant alterations in your manufacturing course of action. And it absolutely indicates that you need to have a strong manufacturing partner who is prepared to enable you meet compliance with no a hitch.

To make certain you have the correct companion, the following are 3 strategic questions to inquire them about GMP compliance:

1.What has been your history of applying GMPs to your production approach and what are you carrying out now to insure you’re compliant?

Long before the FDA’s GMPs went into effect in 2007, many quality companies followed very good production practices borrowed from the pharmaceutical marketplace, other nations, or established informally within just the nutrition industry alone.

It’s definitely doable that some organizations will be able to establish compliance with constrained adherence prior to the establishment of FDA suggestions. But there are clear rewards to working with a companion who has made most of the move presently:

A organization that has been following GMP recommendations ahead of the FDA enforced them is more possible to have a core commitment to good quality. Wouldn’t you somewhat function with a manufacturer who has on its own invested in excellent manage instead than a single forced into it by regulation?

Secondly, acquiring the appropriate tools is an individual matter… Having personnel knowledgeable in employing the tools is a different… And possessing a organization tradition created by these knowledgeable people today – a tradition that previously focuses on looking for issues, spotting them and attending to them – is even much better.

Applying GMPs successfully to manufacturing takes additional than just new equipment or even new personnel. It can take a firm that has woven superior manufacturing into the way it operates. With nicely-tested systems and seasoned people today in put, it can meet GMP needs effectively.

2.Do you use any type of internal auditing to catch issues just before an exterior inspection does?

At one stage or other, the supplement producer you’re operating with will have an FDA inspection of the plant. Hopefully this will go easily with probably a couple of recommendations, but no main problems.

However, the only way to guarantee that there are no disturbing surprises is to be proactive by checking for compliance before the inspector comes. To this finish, see if your dietary supplement producer has set up an inner audit method.

With this process, an inner audit staff routinely pays surprise visits to different departments and assesses their functionality. The team’s reviews enable to initiate discussions, repair issues and increase creation methods. Ideal of all, this comes about before you have an FDA inspector breathing down your neck.

three.How will the implementation of these rules influence my manufacturing charges and timetable?

Just about all vitamin manufacturers have had to make some adjustment to meet new regulations. This contains expenses like new gear, new facilities, or employing new personnel. And these demands have also introduced new schedules to accommodate new methods or added actions like raw materials evaluation. The two the expense and the scheduling can conclusion up impacting your manufacturing prices and agenda.

These new costs are unavoidable. Some firms will not be able to meet the new expenses and will stop up closing as a end result. The ones that pull through, on the other hand, can seem forward to enhanced consumer self-assurance that can only raise the nutritional dietary supplement industry’s constant expansion.

In the brief run, a very good spouse will not only share the increased money burden with you but will also work with you to search for price tag price savings. Potentially it means securing new raw substances or scaling up your manufacturing to larger runs. Perhaps it implies identifying new packaging that will enable you save on shipping.

A good dietary supplement producer will support you seem for alternate options that can aid you proceed creation in a timely manner without having dropping a balanced earnings margin.

For A Productive Partnership, Request Your Dietary supplement Manufacturer These Queries

Meeting these new specifications will challenge your small business on a lot of fronts. By partnering with a good agreement producer, on the other hand, you can streamline the adjustments to these alterations and guarantee your goods and enterprise are compliant.

If you’re already working with a contract producer, inquire your spouse these 3 queries. By doing so, you’ll obtain a deeper insight not only into their potential to meet GMP demands, but also their dedication to do the job with you in creating high high quality items and a powerful enterprise. This discussion will make your partnership a productive an individual.

On the other hand, if your agreement supplement manufacturer companion are unable to aid you meet these requirements to your satisfaction, search for one who can. You’ll avoid a great number of headaches by obtaining a sound GMP-compliant manufacturer. Use these questions as part of your initial interview process.

Vitamin Supplement Manufacturer: Fusion Formulations
So you want to build a successful vitamin supplement branded product. Welcome to the world of Fusion Formulations – a leader in customized contract manufacturing of nutraceutical, vitamin, supplement, mineral and botanical tablets, capsules and powders, plus nutraceutical beverages.

Advantages Of Herbal Dietary Supplement

A dietary supplement, also referred to as food supplement or nutritional supplement, is usually a preparation supposed to supplement eating plans and provisions nutrients, for example vitamins, minerals, fiber, efas, or amino acids, that may be missing or is probably not consumed in sufficient quantities inside a person’s diet. Some countries define dietary supplements as foods, while in others they may be considered drugs or natural health products.

Dietary supplements are popular complementary or alternative medicines for people with shortage of nutrients. Although dietary supplements are regulated because of the FDA as foods, these are regulated differently from different foods and from drugs. Dietary supplements may incorporate vitamins and minerals which our body requires.

Likewise, on account that a nutritional supplement is all-natural by no means shows signs that its good for people; plants can be poisonous. The truth is, some dietary supplements which have ingredients is capable of having harmful, dangerous inter-actions with medications. As a matter of fact ive already been this exact same natural dietary supplement over the past 15 months. Quick Bust is definitely an organic containing no fillers or additives. Because Quick Bust is undoubtedly an natural and organic dietary supplement, of course there isn t any requirement of a prescription.

Using dietary supplements will help you believe stronger immunity level that may keep you healthier making sure that you don’t contract countless illnesses or once you do they will be of your shorter duration. It will also conserve cash by less visits to your doctor.

The health advantages of a natural nutritional supplement might possibly be great, when used correctly also in accordance with all the recommended daily dosage. Counsel patients in regards to the use and recommended dietary intake of selected herbal supplements. Nonetheless it maybe advisable to get a First Opinion, as to whether natural dietary supplements are best for you at this time. Trinovin is usually a natural nutritional supplement which has isoflavones, known to contribute to the maintenance of prostate health. Algo Dynamics’s Ocean Miracle an oral spray, algae based natural dietary supplement for weight reduction, energy boost, well-being, and anti-aging. Some natural dietary supplements can cause health issues compared to improving your health. Some commercially available dietary supplements include a complex mixture of lutein, natural tocopherols along with components.

Fda Approved Appetite Suppressant – What A Dietary Supplements Shopper Needs To Know

When someone is looking for a pill that will help him or her lose weight, it probably seems wisest to go for one that’s been approved by the FDA. After all, with the Food & Drug’s Administration or FDA’s stamp of approval, it’s probably both safe and effective. That is very true, but there are many appetite suppressants out there that do not require prior approval from the FDA. In addition, prescription supplements that could be too powerful for most people are approved by the FDA. In this article, we will explain the FDA approval requirements for weight loss medications and supplements and how to find a safe and effective pill for your needs.

The Precondition of FDA Approval

Over-the-counter weight reduction products do not need approval by the Food and Drug Administration. Phentermine used to treat obesity is a FDA approved appetite suppressant which contains Apidex-P. Alli is the only weight loss aid approved by the FDA that is available over the counter. Alli is a fat blocker pill. The sensation of not being hungry is not directly caused by a pill.

Over the counter appetite weight loss supplement pills do not need FDA approval

Appetite suppressants and other supplements made to help people lose weight weren’t required to get FDA approval before they could be sold over the counter. According to FDA rules, over the counter diet pills are considered dietary supplements made with non-pharmaceutical and known dietary ingredients such as vitamins, minerals, herbs, amino acids and extracts.

If you must have an FDA approved weight loss aid, see your physician, who can prescribe an appetite suppressant pill that will meet your needs. If your goals is to lose weight safely and to try something available over the counter, then take a look at the following tips.

Tips When Shopping For Over The Counter Supplements

People should be careful when choosing the right appetite supplement to take, because appetite supplements do not have to pass through stringent tests to be sure that they’re effective or safe. The manufacturer is responsible for providing a safe product to consumers. However, sometimes, these products do not turn out to be as safe as we want them to be. In May 2010, the FDA asked for certain Brazilian diet pills to be removed from the market after they found illegal pharmaceutical elements in the pills.

Are There Any Studies To Back Up Their Effectiveness?

The first thing to do is to read through the website of the product and look to see if this manufacturer is able to provide a sound and reasonable representation for the safety and effectiveness of the product.

Dietary Herbal Supplements Guide

Herbal Supplements: What are They and What Do They Do?
Are you considering adding herbal dietery supplements to your diet to boost the standard of your nutrition? If thus, it’s sensible that you’re taking the time to read about them. It’s vital thus you can create informed decisions concerning whether or not herbal supplements are a sound health selection for you.

Several folks recognize they are doing not eat a balanced, nutritious diet and fear for his or her health. They feel that adding dietary or herbal supplements to their daily eating regimen will add what they have to their diet. One amongst the foremost common mistakes people make is sometimes mistaking dietary herbal supplements for nutritious herbal supplements.

Dietary herbal supplements are designed to assist you lose weight by suppressing your appetite. Some can block carbs, management carb cravings, boost energy levels and block fats. Others are designed to suppress your appetite, boost your metabolism, burn fat and offer you energy.

Nutritious herbal supplements provide you with the nutrients your body needs. There are six main nutrients the body wants to receive daily. These nutrients embody minerals, carbohydrates, vitamins, minerals, proteins, fats, and water. It is important to consume these six nutrients daily to build and maintain a healthy body. Whereas taking weight loss supplements, once you eat it is important that your diet is nutritious and balanced.

Herbal supplements will augment your diet. However given the shortage of controls, it is a bet to trust that any herbal dietary or nutritious supplements you may take contains all the ingredients at the intensity the label says. This is often unhappy but true. Billions of greenbacks are spent on these supplements that will, for all we tend to apprehend, be powdered sugar. Everyday, there are news stories about supplement frauds and hoaxes.

There is hope though. Makers of dietary, nutritious and herbal supplements can ask that their product be tested for free. If they meet the standards established by the U.S Pharmacopeia, they are allowed to position the USPS Dietary Supplement Verified Seal on their product. Different teams that certify herbal supplements embrace:
1) ConsumerLab.com
2) Good Housekeeping
3) NSF International (National Sanitization Foundation)

Then there’s the FDA, the US Federal Drug Administration. Supplements that are created using Good Manufacturing Practices set forth by the FDA, and strict FDA pointers are thought-about safe and effective.

Though you get herbal supplements that have been tested by one of these organizations, and they carry their seal or certificate, or the approval by the FDA, you can’t depend on supplements for counteracting poor and unhealthy eating habits. There’s no supplement that can work with changing your dietary lifestyle.

If you’re taking prescription drugs, you would like to be even additional cautious regarding the supplements you take. You’ve got already passed the stage of prevention and are within the treatment stage. Herbal supplements are known to stop and treat sicknesses and ought to be used underneath a doctor’s supervision if you currently take prescription drugs.

There are distinctive, safe and effective herbal supplemental products available for certain conditions that facilitate individuals supplement their lives. And herbal weight loss products there are products for girls’s health, men’s health, skin care and general health products.

If you are wondering using herbal supplements as an alternate to pharmaceuticals, the same caution is made – you wish to make certain the supplements you are taking meet quality standards and don’t seem to be frauds.
seven suggestions to contemplate when shopping for herbal dietary or nutritious supplements on-line are:
1) Check how long they have been selling herbal supplements on-line, as typically the longer the better.
two) Do they have concerning me, faqs, testimonial, ingredients pages etc?
three) Products on their web site ought to contain a full description. Check after you receive the product the description matches or exceeds the data on the website.
four) What guarantees do they offer?
five) Subscribing to a newsletter may be a good sign.
6) Shipping worldwide.
7) Be leery of herbal supplements made outside the U.S.

Following the suggestions ought to offer you a smart plan of the corporate you are dealing with. However be a smart consumer and let your antenna go up when a product’s claim is just too good to be true.

It’s important to remember that no matter guarantees they create for the supplements you are taking they will all have the identical in common… They’re not instant fixes, they need time to work and would like your help to work. You have got to remain the course and follow the counseled dosage level, and the advice given by the manufacturer of the herbal dietary supplement.

Nutritional supplements can facilitate improve your health no matter what you eat, however taken together with a well-rounded diet, your health can achieve even higher levels. It could take months before you get the full profit, but relying on your condition and the merchandise you use you could see or feel results inside week’s even days.

How To Choose The Best Dietary Supplement Products

Individuals are overwhelmed by the dietary supplement products available in the market. There are several manufacturers offering different types of dietary supplements. However you must buy them after looking at their ingredient as in the best dietary supplements contain fewer ingredients.

As you try to make it through the shelves of supplements without getting weighed down you will easily notice that there are half-dozen varieties of similar vitamin and mineral recipes. Moreover there are infomercials telling you about different supplements and their necessity and urgency. It is essential to understand what vitamins, minerals, hormones or herbs your body really needs before buying any dietary supplement.

The nutritional industry is a big business in the United States. Each year the sales figures are increasing and despite the fact that the FDA has a definition for dietary supplements, a definition itself is not enough to determine best product for your health. Prior to buying you must understand what you’re trying to accomplish and which ingredients will help you reach those results. Since dietary supplements are manufactured to supplement an existing diet they are naturally not a permanent replacement for food. Many companies may market them as such but it is the duty of a savvy consumer to avoid the trap.

There are certain members that require adding supplementation to their diet which includes senior citizens, strict vegetarians, those with food intolerance or allergies, nursing and pregnant women, individuals with diseases, as well as healthy individuals involved in extreme conditions and exercise routine and stress. For people who cannot consume solid meals because of illness or injury find dietary supplements in form of powders and liquid very helpful. Liquid dietary supplement is an ideal form of diet because they offer many calories and vitamins per serving, making it easier for the ill or injured to take in enough energy to recuperate faster.

There are sports nutrition dietary supplement products which are used to improve performance, lose weight and gain muscle tone. Some of the safest supplements are calcium, vitamin B that includes B12, riboflavin, niacin and thiamin. In addition Vitamin C and vitamin D are definitely very necessary. Dietary supplements are an important part of sportspersons life and encompass effective sport training. Sportsmen working under extreme conditions, pushing their body to the limits, need tools and knowledge to train for peak performance and in addition need the best dietary support.

Increased Trouble for Dietary Supplement Liability Insurance Applicants

On Dec. 22, 2007, a bill signed by President Bush a year earlier became law. It set a required reporting system of profoundly adverse events (SAE) for dietary supplements sold and used in the United States. With further requirements, it mandated the company whose name appears on the product hold records related to every report for six years from the time the report is initially received.

In spite of this, just those adverse events that are “serious” must be reported. The definition of “serious” is understandable and includes, but isn’t restricted to, death, a life-threatening experience and in-patient hospitalization.

But has any person studied the implications of not disclosing SAE reports to their product liability insurance carrier? No, and the consequences of not doing so could be dire.

Almost each application for product liability insurance for dietary supplement companies has a question identical or very similar will this: “Is the applicant aware of any fact, circumstance or situation which one might reasonably expect could give rise to a claim that would fall within the scope of the insurance being requested?” Companies subject to the new SAE notification requirements should think about this subject carefully prior to responding either “yes” or “no.” If a business is maintaining the required SAE records, can the company in good faith answer “no” to the question? Hardly.

And what are the aftereffects of answering the question falsely? Put plainly, if a lawsuit arises from a previously documented SAE incident, the insurance company will confidently deny the claim after it discovers (and it will) the SAE was documented in the companys records. The insurance company will allege fraud for inducing it to issue a policy based on concealed information. It will not simply deny the claim, but most likely will look to rescind the policy completely.

Thus, the latest SAE reporting requirements have introduced a new necessity to disclose such events to a product liability insurance company when applying for the insurance, or risk a claim turned down when a claim is created.

The GMP (good manufacturing practice) inspection procedure holds comparable risk. It is well known the amount of FDA inspections for GMP conformity have risen dramatically. According to FDA data, only seven GMP inspections occurred in 2008, which increased to 34 in 2009 and to 84 in ’10. As of Sept. 13, there have been 145 inspections in 2011. A lot of of these inspections have resulted in warning notices to companies citing a range of violations and calling for a swift reply outlining remedial steps to be followed. These letters are a matter of public record and can be seen on the FDAs website. With the number of inspections and enforcement undertakings overall on an abrupt rise, it stands to reason that more companies will be receiving a warning notice of some gravity in the near future.

An additional question on nearly all product liability applications is virtually the same as or identical to this: “Have any of the applicants products or ingredients or components thereof, ever been the subject of any investigation, enforcement action, or notice of violation of any kind by any governmental, quasi-governmental, directorial, regulatory or oversight body?” Once more, a “yes” or “no” answer is called for. If a business has had an audit that resulted in a warning letter, it again should ponder carefully before answering the question. If the company has been issued a warning notice, the only logical response to the question is “yes.”

Clinically Authorised Weight Loss Dietary Complement Is Rated As #1 Fat Burner

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Ephedra God Father of All Dietary Supplements

A natural herbal plant known as Ephedra was widely found in China. This is commonly used to treat asthma and related diseases. Ephedrine is the principal ingredient of Ephedra which functions to stimulate the nervous system beside the heart. It is medically known to increase blood pressure and heart beat rates. Study also shows that is can help to restrain appetite but will provide more energy to its users. Stimulant supplements like Ephedra and Ephedrine Hydrochloride were banned by FDA due to its danger on its users. It is advised to seek for a professional help before taking these dietary supplements. Nowadays Ephedra is making its way back on weight loss supplements since the restriction has been lifted by FDA. Taking Ephedra or Ephedrine has it’s dosage to be followed. The recommended dosage according to professionals is up to 25mg of Ephedra or Ma Huang, Ephedrine in the form of capsules. This is now very visible on all internet markets all over the world. These drugs were already reformulated to feel its effect within minutes of taking it. Ephedra Pills is known to be the most effective dietary supplements for fat burner, weight loss programs and also considered to give the highest level of energy among all of the dietary supplements in the market. Still professionals advised cautions in taking Ephedra Pills that are said to cause a dramatic increase in activity of the entire nervous system. Ephedra Pills can also bring stimulatory effects on the cells. Ephedra Pills are also said to enhance skeletal muscle contractions which will result to an effective performance level. With this being said Ephedra, Ephedrine which is also known as Ma Huang is considered to be the God Father of all Dietary supplements.

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Dietary Supplements And Nutraceuticals Compliance With Fdas Current Manufacturing Requirements

Recently FDA announced an aggressive campaign to enforce the Good Manufacturing Practices (GMP) regulation on manufacturers and suppliers of dietary supplements in the US. Also, a vast majority of supplements are imported from manufacturers located in countries with poor GMP requirements for such products.

To address these issues, FDA now requires manufacturers of dietary supplements to follow GMP requirements closer to those for drugs than those for foods. These requirements include stricter documentation, standardized processes, use of trained personnel, adequately designed facilities, quality testing, packaging and shipping, and audit trails of processes. These requirements have created lots of anxiety in an industry filled with small businesses with few products, and international companies marketing in the US.

Compliance techniques can be simple and implemented with relative ease leading to better products both in terms of quality and potential benefit to consumers leading to better acceptance.

If you are a manufacturer, importer, supplier, stocker, marketer, shipper, or user of dietary supplements, this webinar will describe the US GMP requirements and techniques to be compliant using easier, shorter and convenient strategies. We will discuss ways to demonstrate compliance to the current regulations and regulatory trends for the near future. Common findings and possible solutions will be discussed. Case studies will be presented for audit experiences in many countries including US, China, Israel, Taiwan, and India.

Areas Covered in the Seminar:

– Key manufacturing issues related to dietary supplements and nutraceuticals.
– Raw material sourcing, validation, accountability, and documentation techniques.
– Facility design and planning issues.
– SOP and training requirements.
– How do these changes impact products currently in the market.
– Techniques to ensure compliance at international manufacturing sites.

Learning objectives:

Learn how to be compliant with current GMP requirements in the US for dietary supplements in less than an hour to increase credibility of existing products and make it easier to launch more products in the US market in the near future.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

– Manufacturers and marketers of dietary supplements
– QA/QC/Compliance/Regulatory affairs professionals
– Regulatory and quality professionals working in companies involved in manufacture and sale of dietary supplement, nutraceuticals and similar products
– Regulatory and quality professionals working for US companies that are considering the purchase of such products manufactured in non-US markets or vice versa
– Regulatory, compliance and quality professionals consulting with companies developing such products for the US market
– Business professionals looking to understand the risks and benefits of investing in such products
– Senior management of such companies in India, China, Africa and Latin – America considering marketing their dietary, nutraceutical and similar products in the US

Instructor Profile:

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( www.amarexcro.com ). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide.

Fda Guidance Regarding Clinical Trials For Foods, Food Ingredients, And Dietary Supplements

Description:There has been an explosive growth in the market for dietary supplements, both in terms of expansion of range of products and increase in number of people using them. In a high growth market in which processes and results are subjective in contradiction to the hairsplitting exactness required of pharma products there is scope for spurious and unverifiable claims over the purported benefits of several dietary supplements.
Regulation of this industry lies beyond the purview of the FDA. So, it can only offer recommendations and not set stringent standards for dietary supplements. It works in conjunction with the Federal Trade Commission (FTC) to ensure that manufacturers and distributors are up to date with the requirements for product labeling and acceptable marketing claims. The FDA is likely to become more actively involved in framing more stringent regulations about this industry in the future. This webinar will examine the existing recommendations from these bodies.
It will take up two important guidance documents on this issue, namely “Dietary Supplements: An Advertising Guide For Industry” and “Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act”. The first of these deals with identifying advertising claims and interpreting them; while the second relates to the FDA recommendations to a product manufacturer have to substantiate a claim under section 403(r) (6) of the Act.
When: Tuesday, November 20, 2012 , 10:00 AM PDT | 01:00 PM EDT
By whom:Joy Frestedt, PhD, CCTI, RAC, FRAPS, is the President and CEO of Frestedt Incorporated, a novel virtual Contract Research Organization network of over 50 experts and highly skilled staff meeting specific needs in regulatory, clinical and quality affairs.
Dr. Frestedt has over 30 years of scientific, clinical and regulatory experience in the health care, pharmaceutical and medical device industries especially running clinical trials, conducting laboratory analyses and assisting firms with strategic decisions involving clinical research programs, regulatory strategies and the development of quality systems to compete globally.
Dr. Frestedt holds a B.A. in biology from Knox College and a Ph.D. in pathobiology from the University of Minnesota Medical School. She was named one of the 100 Most Inspiring People in the Life Sciences Industry (by PharmaVOICE, 2011) and one of the top 25 Industry Leaders/ Women in Business Award (by the Minneapolis/St. Paul Business Journal, 2011).
For whom:
The webinar will benefit
oDietary Supplement Manufacturers
oDietary Supplement Distributors
oSales/Marketing Personnel
oPresidents and Executives of Dietary Supplement companies
oManagers of Quality Affairs
Duration: 60 minutes
To enroll for this webinar, contact

Phone: 800-447-9407