Food safety concerns and issues and ways of mitigating them

Food, despite being the most important human need, is fraught with many risks and hazards. The food chain, which consists of activities that cover everything from the proverbial farm to fork, passes through many points at which a harm of any nature can happen. The chances of risks to the food safety chain are all the more amplified in this age of globalization, when food travels through many regions and continents from its source to its destination.

The UN’s Food and Agricultural Organization (FAO) has identified five major issues with the food chain. These are:

o  Hazards of a microbiological nature

o  Residues left over by pesticides

o  Food additives

o  Chemical contaminants, such as pesticides; and

o  Adulteration.

Many other risks

Of late, this list has been extended to include genetically modified organisms, allergens, veterinary drugs residues and growth promoting hormones used in the production of animal products.

Further, other hazards to the food chain include antibiotic resistance, demographics, meaning the proper distribution of food to the right people, the effects from the environment, and foodborne illnesses. This clearly shows that there is no dearth of sources of hazards in the food chain.

Defining food quality and food safety

While these are the commonly identified areas of the food chain that are considered hazardous; a more fundamental issue for food specialists is in defining food quality and food safety. These have different meanings for food specialists. Identification and elimination of all the hazards that make food injurious to the eater is part of food safety. Anything that gives and enhances the value of the food to the consumer is considered a characteristic of food quality. Food quality can also include any negative traits such as spoilage, discoloration, rotting and stench, all of which affect the quality of food.

In view of the nature and expanse of the points at which hazards can happen in the food chain; it is necessary that there has to be a global cooperative effort aimed at checking these and ensuring food safety. Ensuring food safety at the local, national and global levels requires a high level of cooperation and coordination, not to speak of the sheer perseverance needed for it. A number of safety and quality standards have been in place for the food industry to adhere to. Compliance with these regulations goes a long way in eliminating a number of hazards and ensuring the quality and safety of food along the chain.

A webinar on food safety

All the aspects of food safety will be covered at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Michael Brodsky, who brings varied and deep experience of over four decades into food safety aspects and holds the position of lead auditor/assessor in microbiology for the Canadian Association for Laboratory Accreditation (CALA) and is a member of the Board of Directors among many others, will be the speaker at this webinar. To understand all the aspects of food safety from the expert, please register for this webinar by visiting

http://www.compliance4all.com/control/w_product/~product_id=501352LIVE?Wordpress-SEO

Thorough understanding of all the aspects of food safety

At this webinar, Michael will address the complexity of defining safe food. All the important aspects of food safety, such as the changing nature of foodborne and food transmitted pathogens, new and emerging analytical technologies and the influence of demographics and geography on the changing landscape, and the roles and responsibilities for various stakeholders along the food chain in identifying and eliminating foodborne illnesses and contamination will be discussed at length.

With the world’s population burgeoning, especially in areas that are vulnerable to food safety issues, emerging pathogens present a set of new challenges to everyone in the food chain, such as food producers, food safety regulators, consumers and food microbiologists. Michael will highlight these issues and explain what responsibilities each of us has in ensuring that food is safe and what cooperative efforts we must all put towards attaining this objective.

Michael will cover the following areas during this webinar session:

o  Defining food safety

o  Risks and realities

o  Statistical reliability

o  New and emerging analytical technologies

o  The multiplicity of interacting factors

o  The changing landscape

o  Mitigating the risks.

Maximizing profits and patient outcomes in the backdrop of declining reimbursements

In the situation of falling revenues from Medicare billing, many practitioners are worried about the state of their future earnings. A very tangible factor that will help them tide over this problem is often overlooked: the Durable Medical Equipment (DME) program.

The DME program is a very reliable and long term source of income for Medicare practitioners. Yet, this is not considered seriously by most of them because of the various misconceptions that are associated with this program. Not only is the DME program absolutely valid legally; it is a terrific means by which practitioners can build a highly lucrative income avenue.

Building a steady revenue stream

Of course, there are a few provisions and conditions that need to be met if the DME program has to become successful. Being compliant with these requirements not only ensures that highly improved patient outcomes by protecting senior patients from unnecessary, debilitating surgeries that their bodies cannot cope up with at such a late stage of life; it also assures practitioners a steady income stream of the range of $10,000 a month, that too, with just one patient a day. This is all the more important in these times of decreasing patient traffic and professional services reimbursements from insurance companies but more so from Medicare, on the one hand, and increasing, even skyrocketing operating costs on the other.

The ways of attaining this kind of revenue stream will be taught at a very valuable webinar on this topic. It is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. The speaker at this session is Gregory Simms, who has provided this DME Revenue Program model successfully across the country for hundreds of medical practices in numerous practice specialties. He is known in industry circles as the man who developed his revolutionary new Durable Medical Equipment Revenue Program in the Healthcare Industry in 2006.

To get to understand what it takes to build a highly effective, compliant and lucrative DME program that meets its desired outcomes, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501329LIVE?Wordpress-SEO

A full exposition of the DME option

The core purpose of this session is to debunk popular myths about DME practice. For years, practitioners have been depriving themselves of this revenue stream because they have been referring the business to O&P shops, manufacturers or 3rd parties. The reason: The wrong belief that it is illegal and not profitable for them to adapt and implement a DME program.

Gregory will correct this fallacious line of thinking. If done following proper guidelines and regulations with appropriate protocols and processes, these can be developed into a full-fledged, profitable program that greatly enhances the value that practitioners provide to their patients, as well as their own practice.

All the tools needed for setting up a successful, compliant and effective DME program

At this webinar, Gregory will lead participants into the right direction on what is needed to set up a compliant DME program, starting with accreditation. He will show them how to obtain a DME PTAN license to bill Medicare and how to deal with their legal guidelines to prevent audits. He will show participants the ways of complying with Federal Guidelines such as the Stark Act & Anti-Kickback Statue. All these of course, will be carried out while ensuring a high degree of patient convenience and optimization of their clinical outcomes.

Doctors, owners or administrators of either general practice or of the Pain Management, Orthopedic, Neurological, Chiropractic, Podiatry, Physiatry, and Family Practice & Internal Medicine will benefit immensely from this session.

Gregory will cover the following areas at this webinar:

o  Business Opportunities

o  Legality

o  Myths vs. Reality

o  Operational Necessities Guidelines.

FDA holds Cosmetic Manufacturers & distributors responsible for the safety and quality of their Cosmetics

Testing cosmetics before the FDA does it is a sound business strategy for cosmetic manufacturers. This is why: Cosmetic manufacturers and distributors are responsible for upholding the quality and safety standards set out by the FDA. This is a legal requirement on the part of players in the cosmetics industry. In order to ensure compliance with its safety and quality standards; the FDA routinely carries out its own analysis of cosmetics.

The regulatory agency is all the more proactive in carrying out its quality and safety checks on products that carry potential problems. It comes down heavily on such manufacturers by alerting consumers about the problem product. It also carries out regulatory and enforcement actions against such products and companies.

Another reason for which cosmetic products need to be tested thoroughly for their quality and safety is that although the FDA does not require cosmetic products and ingredients, except color additives, to get approved by the FDA before they enter the market; it has laws on how these cosmetic products need to be regulated in interstate commerce. This makes it necessary to comply with the FDA’s standards on cosmetic safety and quality.

One of the lines of defense for such companies is to carry out testing of their product themselves before they start selling it in the market. This is a sound practice that helps companies in the cosmetic industry avoid punitive actions from the FDA.

Getting the testing practice right

But then, this practice has to be inculcated in the right manner, or it serves little purpose. The ways of implementing the right methods for testing the quality and safety standards of cosmetics before they are distributed into the market will be taught at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, the speaker is Rachelle D’Souza, who, as CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities/agencies for multinational and start-up companies. The major learning Rachelle will offer at this webinar is the different ways by which to carry out practices that are prevalent in the cosmetic industry to help avoid enforcement actions from the FDA.

To gain knowledge of avoiding punitive actions from the FDA; please register for this webinar by visiting  Cosmetic Testing

Guidance on the FDA’s expectations

The important learning that this webinar will offer is that it will offer thorough guidance to cosmetic manufacturers and distributors, as also other entities such as color additive manufacturers and analytical and microbiological laboratories, on the recommendations and requirements that the FDA has with regard to the safety and quality testing of cosmetics.

In line with this topic, Rachelle will help participants explore important areas in this webinar, such as FDA considerations for microbiological testing, animal testing, potential contaminants, nanomaterials in cosmetics, cosmetic good manufacturing practices (GMP) compliance testing, shelf life/expiration dating, select cosmetic ingredients and color additive batch certification.

The content of this webinar is suited to act as a proper guidance to those involved in the various aspects of cosmetics, such as Cosmetic Manufacturers, Cosmetic Distributors, Cosmetic Ingredient Manufacturers, Color Additive Manufacturers, and Analytical and Microbiological Laboratories involved in Cosmetic/Cosmetic Ingredient Testing. They will benefit in a big way by learning about areas of FDA cosmetic regulations that Rachelle will explain at this session. She will cover the following areas at this webinar:

o  Microbiological Testing for cosmetics

o  Animal Testing & Cosmetics

o  Potential Contaminants

o  Color Additives & Batch Certification

o  Select Cosmetic Ingredients: Prohibited & Restricted Ingredients

o  Shelf Life/Expiration Dating

o  Nanomaterials in Cosmetics

o  Cosmetic Good Manufacturing Practices (GMP) Compliance Testing.

Implementing the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

The FDA’s Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food, which was passed on April 6, 2016, has now become final. This is the latest in a series of as many as seven rules that have been getting legislated from January 2013 with the intention of creating a modern, risk-based framework that ensures food safety.

This Final Rule has, like its predecessors, been created with the goal of preventing practices that create risks in food safety during transportation. Failure in properly refrigerating food, not ensuring sufficient and thorough cleaning of vehicles between loads, and inability to protect food fully and properly are some of these risks and methods. In its efforts at preventing food contamination during transportation, the FDA seeks to enhance its endeavor of protecting foods “from farm to table”.

Takes off from the 2005 Sanitary Food Transportation Act

The foundation to this Rule can be found in the safeguards the FDA envisioned in the 2005 Sanitary Food Transportation Act (SFTA). Following the FDA’s identification of transportation as a major source of food contamination; it has formulated its seven Rules targeting this particular activity. It seeks to address the concerns of contamination during transportation and has brought about this regulation to ensure that foods are safe during transportation.

Towards facilitating this goal; the Final Rule on sanitary transportation of human and animal food establishes sanitary practices requirements which shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food have to comply with.

Learn the ways of complying with the Final Rule

How do food transporters ensure that they mitigate the risk associated with their business, and how do they comply with this regulation? The ways of doing this will be the learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

This webinar is part of three training sessions that are required for transporters as part of the Final Rule of April 6, 2016. Trainings for the subsequent two sessions will be carried out later. In this session, which is entitled “Responsibilities of the Carrier Under the Final Rules”, John Ryan will cover the training requirements that all carrier personnel engaged in food transportation operations, except those that are exempt, are required to establish. As part of this requirement, they are further required to earn training certificates for the following:

o  Responsibilities of the carrier under the final Sanitary Transportation rules

o  Awareness of potential food safety problems that may occur during food transportation

o  Basic sanitary transportation practices to address those potential problems.

To understand the ways of implementing the Final Rule, please register for this webinar by visiting Final FDA FSMA Rules

Everyone involved in food transportation activities, such as Drivers, Managers, Compliance personnel, Buyers, Supervisors, Internal food safety team members, Maintenance Personnel, Loaders/Unloaders, Inspectors, Trainers and Food Shippers will find this session very useful.

John will cover the following areas at this webinar:

o  Understand US FDA FSMA Law for the Sanitary Transportation of Human and Animal Foods

o  Understand changes from the proposed FDA FSMA rules

o  Know the different requirements for shippers, carriers and receivers

o  Know who is exempted

Understand the FDA waiver requirements.

Clarifying the misconceptions about DMFs and Quality Agreements

A Drug Master File (DMF) is a file that lists the materials and processes that have gone into a drug. This submission is made by manufacturers of drugs to the FDA, and has to contain everything that goes into the drug, and has to include not only the materials and the processes; but also confidential information pertaining to the facilities in which the drugs are manufactured. All the inputs that have gone into not just the manufacturing, but also the packaging and storing of all human drugs made by the manufacturer, have to be entered in the DMF.

The FDA’s line of thinking is that all this information has to be provided to it so that it will help the manufacturer protect any confidential or proprietary information relating to its manufacturing process by keeping them with the FDA.

The FDA has issued a number of guidances to the industry about the way in which these submissions have to be made in both paper and electronic format. It has detailed information about how each of these is to be made. This format is set to change, because from May 18, 2018; only DMF submissions made in electronic format under the FDA’s Electronic Common Technical Document (eCTD) will be accepted, and the FDA will reject any DMF submissions made in paper format from that date onwards.

The Quality Agreement

A Quality Agreement (QA) is an important document that goes some way in ensuring the quality of drugs and preventing their contamination and counterfeiting. It is an agreement made between the manufacturers of API or intermediate manufacturers and their suppliers to ensure that the responsibilities for assuring the safe supply of materials are safe to be accepted for pharmaceutical use.

A Quality Agreement stipulates and clearly defines the responsibilities of both the manufacturer and the supplier, and states their respective obligations towards ensuring the quality and safe supply of the API or intermediate user. The Quality Agreement is a major component of the API or intermediate user’s supplier qualification program.

While this is a laudable intention, it has a side effect: Misunderstanding between manufacturers of pharmaceutical or biologic finished products on the one side, and supplier and contractors, on the other, because the FDA states that all the proprietary information is to be stored with it only.

This has given way to considerable confusion and misconception about the nature of the DMF submission and the way in which the Quality Agreement has to be drafted. Yet, it is important to clear the misconceptions and misunderstandings at an earlier stage of the agreement, because proper understanding of the requirements and responsibilities alone can ensure the proper quality of the final product.

The aim of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, is to clear the many misunderstandings between the supplier and the manufacturer.

The speaker at this webinar is Robert J. Russell, who is President of RJR Consulting, Inc., which is engaged in assisting the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and Quality Assurance. To have misconceptions in the various areas of DMF and QA clarified, please register for this webinar by visiting Regulatory and Processing Responsibilities

This training will combine Quality Agreement and DMF, and is meant for suppliers and drug product manufacturers developing these arrangements together. Robert will discuss the advantages of this system.

He will offer understanding into the nature of the misunderstanding that has arisen over the years. The main reason for this is the lack of a thoroughly drafted agreement that delineates roles and responsibilities. The speaker will explain how this can be corrected by clearly stating the means for resolution of issues.

This will be the agenda of this webinar:

o  What are DMFs?

o  The rationale and preparation process for DMFs

o  DMF Preparation: What you need and why you need it

o  FDA Review: How FDA reviews DMFs and why

o  Components Associated with a DMF

o  Japan DMFs

o  European DMFs

o  Canadian DMFs

o  Change control and maintenance: Why accurately maintaining your DMFs is important

Webinar Calendar of Upcoming Courses – May to Jun 2017

webinar-training-online-education.jpgBelow is the event description content:

Compliance4All webinars are just what professionals in the regulatory

compliance areas need for scaling up in their careers. With a collection of

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Compliance4All’s experts help you unravel all the knowledge you need in all

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causes no stress for you. Compliance4All’s experts offer their insightful

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in their daily work. Their thoughts help you implement the best practices of

the industry into your work. They also offer updates on the latest regulatory

requirements arising out of a host of the laws and issues related to

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and Beverages, Software, Embedded Technologies, Energy and Utility,

Payment Card Industry (PCI), and lots more.
Take a look at our upcoming webinars from Compliance4All, which will put

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For more Calendar Webinars http://www.compliance4all.com/control/webinars_home

Meeting labeling requirements of various drug products

Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Fair Packaging and Labeling Act (FP&L Act) are the laws that manufacturers of these products need to comply with in order to meet labeling requirements of these products. These laws are separately made for a number of products and their subcategories, such as drugs, cosmetics, cosmetics that are also drugs, and so on. In addition, the regulations set out by the EMA also need to be complied with by manufacturers of these products, if they plan to market to the EU markets.

One of the elementary requirements of the FDA is that the ingredients of the cosmetics must be declared prominently. By this definition, the prominence should be such that users should be able to see the declaration when they purchase and see the product. The FDA prescribes that the letters in the ingredient declaration should be not less than 1/16 of an inch in height. In cases where the total package surface available for labeling is less than 12 sq. inches, the height of the letters must be at least 1/32 of an inch.

Particular about the specifications

The FDA also requires that the ingredients must be declared in descending order of importance. Color additives must be declared too, but does not require an order of prominence. The active ingredients, as well as the additives, must be clearly declared. Labels should carry warnings when they carry ingredients that are likely to cause damage to some or another part of the body. Products such as aerosols, deodorant sprays used by females, and soaps and other cosmetics used by children have their own labeling requirements.

If all this is a snapshot of the only the prominent labeling requirements for just cosmetics, imagine the kind and variety of requirements that need to be met for all other related products such as medical devices, drugs, vitamin supplements and many others. And what about understanding the EMA’s requirements?

Knowledge of the labeling requirements of the products need not be intimidating, because this is the content of a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Learning session on labeling

The speaker at this webinar is Salma Michor, who is founder and CEO of Michor Consulting Schweiz GmbH, which serves such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. The full extent of Salma’s experience will come into play at this webinar. To register for this session and to benefit from the wealth of Salma’s experience, please register by logging on to Labeling Drug Products

This webinar will focus its attention on the ways by which to remain compliant with the labeling requirements of the various regulatory bodies vis-à-vis a number of products. Salma will explain the challenges associated with remaining compliant with the labeling requirements of products such as generics, prescription drugs, OTC drugs, medical devices, vitamin supplements, traditional herbal remedies, foods, cosmetics and biocides, and will suggest ways of dealing with them. She will focus in particular on the EU requirements for labeling of these products. Regulatory Affairs and labeling specialists will understand the intricate details of the labeling requirements for these products at this webinar.