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.

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

Why IEC 60825 certification cannot be substituted for 21CFR1040

With a few exceptions, it is necessary for manufacturers, system integrators and importers of lasers or laser containing products to implement best practices for compliance with FDA 21 CFR 1040. This is because The Center for Devices and Radiological Health (CDRH) requests documentation using the current version of their Form 3632 Guide for Preparing Product Reports for Lasers or Products Containing Lasers for laser self-certification submittals, which have to comply with 21 CFR 1040. Per Section 1010.2c, certification has to be based on a test that meets the requirements set out in this standard and has to be in accordance with Good Manufacturing Practices.

Since the CDRH does not approve form 3632 reports or the products being reported; it is incumbent upon the manufacturer, system integrator or importer to assume responsibility for certification. However, if the FDA detects gaps or deficiencies in the applicant’s quality control or testing program; the CDRH is empowered to take actions that are of a very harsh nature. It may:

o  Ask the manufacturer to halt introduction of the product into the US until the faults are corrected

o  Require the manufacturer to start a corrective action program for products that have already been released into the market

o  Impose fines of up to $300,000 for non-compliance with the requirements laid out in 21 CFR 1040.

What are the consequences of recalls?

When laser products that the FDA determines do not meet the regulatory requirements are recalled, it can have serious consequences for the business. It invites lawsuits from the user of such products. This can result in monetary losses that eat into the business’ profits. It can also damage the company’s reputation, which is something that is very difficult to overcome and compensate for.

So, the ideal course to follow for manufacturers of laser products is to be compliant in letter and spirit with the regulations laid out in 21 CFR 1040. The ways of achieving this and implementing best practices for compliance with FDA 21 CFR 1040 will be the teaching a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Tony Imm; a nationally recognized laser engineer with a background in medical device manufacturing, whose company, Laser Guardian LLC provides a wide range of laser safety and process support. To understand the ways by which to achieve compliance with FDA 21 CFR 1040 by implementing best practices; please register for this webinar by visiting Best Practices for Compliance with FDA 21CFR1040

Complete understanding of implementing best practices

Tony will give comprehensive understanding of the ways by which the test documentation system with the CDRH works. He will show how to generate form 3632 document, how to complete the form, what supporting data to attach with it and how, and then explain recommended methodologies to test and record the emission output and interlock performance of the laser systems. This session is extremely useful to those involved in working with laser products, such as Engineering Managers, Laser Engineers, Safety Manager, Safety Engineers, and personnel responsible for FDA communications.

Tony will cover the following areas at this webinar:

o  What is self-certification and when is it required

o  Methods for submitting a product report

o  Major sections of the product report

o  Why IEC 60825 certification cannot be substituted for 21CFR1040

o  What are best practices and why use them

o  Where to apply best practices and what they should encompass.

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

the most erudite experts on regulatory compliance being available at a click

in the comfort of your preferred location; regulatory compliance could not

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

the areas of regulatory compliance. They help professionals like you

implement the regulations and stay updated, so that regulatory compliance

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

analysis into the issues that are of consequence to regulatory professionals

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

regulatory compliance, such as Pharmaceuticals, Biologics, Healthcare, Food

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

you on the road to learning about any area that is of importance to your

profession. You can plan your learning from Compliance4All by looking at

our events in the next few weeks. You can choose from a whole range of

topics. See which among these trainings suit you: FDA Regulation of

Medical Device Software, Conducting Successful Product Complaint

Investigations, CAPA, Failure Investigation and Root Cause Analysis, 1099

and W-9 Update, Laboratory-Developed Tests, avoiding an FDA 483,

Equipment Validation, and much more!

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

About 7 decades since the FDA was first formulated in its earliest avatar

Considering the slew of regulations that exist for medical devices today –to the extent that this is among the areas of the highest regulation from the FDA –it is rather ironical that the US Congress had not empowered the FDA to regulate medical devices till as recently as mid-1976. This is when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA). This was about seven decades since the FDA was first formulated in its earliest avatar.

The reason for which medical device software started getting regulated during this time is that it was in the mid-1970’s that computer software started to grow and evolve into a field of its own. Being in a state of infancy for most of that decade; it was only towards the end of the next decade that software began to get used in medical devices, albeit in a manner that appears rather crude by today’s standards. Because of this, the FDA did not have the need to create a software regulatory policy.

Separate regulations based on the nature of devices and software

Since then, however, software has made giant strides in its uses in medical devices. The growth has been so fast and wide-ranging that today, there are regulations for:

o  Software that can be a device by itself (i.e., stand-alone, or what the FDA calls Software as a Medical Device or SaMD)

o  Software that is incorporated into another device as a component, part or accessory.

Other factors to be taken into consideration

So, the FDA’s regulations on medical device software are based on its thinking that there is a distinction between stand-alone software and software that is a component, part or accessory to a device. Also, software validation is a major theme for most manufacturers of medical devices. Software validation of medical devices has to be not just satisfied; it has to be evidenced from a number of stringent perspectives. There is a clear distinction between medical device software and medical device hardware. Additionally, there are design user requirements to be met, and off-the-shelf software and automated equipment have to be validated.

In the realm of clinical valuation of an SaMD; the FDA requires medical device manufacturers to meet and demonstrate reasonable assurance of safety, performance and effectiveness since these devices have a very major impact on the health and safety of its users. This clinical evaluation has to thus be thorough and systematic, and should be well planned. The FDA’s clinical valuation of an SaMD should meet the following:

o  Clinical validity

o  Scientific validity

o  Clinical performance

o  Analytical validity

Deep and clear understanding

Professionals who work in the field of medical devices and whose work is related in some or another way to medical devices need to be aware of the FDA’s regulation of medical devices. This requires detailed understanding of the regulations as they exist, as well as the knowledge needed to interpret and apply them into medical devices or software, whatever the case may be.

This is the understanding a webinar from Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will be offering. Thomas E. Colonna, who provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics, medical device software and biotechnology-based products, and holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia, will be the speaker at this webinar.

To gain complete understanding of the FDA’s thinking on medical device regulation and to get a grasp of how to apply it for practical use, please register for this webinar by logging on to FDA’s Regulation of Medical Device Software

At this webinar, Dr. Thomas E. Colonna will offer fundamental understanding of FDA regulation of medical device software. Expectedly, this session will be of immense benefit to professionals at various levels in the field of medical devices and medical device software, such as Compliance Managers, Validation Managers, Regulatory Managers, QC Managers and QA Managers.

At this session, Dr. Colonna will cover the following areas:

o  Definition of medical device software

o  FDA’s medical device software regulatory scheme

o  Software validation

o  Level of concern.