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.

An effective internal audit program is indispensable for continuous improvement

Both the ISO and the FDA require an internal audit program of an organization’s Quality Management Systems. This is a core requirement. The simplest way to understand an internal audit system is that it is a tool to assess or inspect an organization’s Quality System.

Apart from helping organizations to fulfill the requirements of auditing set out by the ISO and the FDA and other regulatory bodies, audits, be they internal or external; carry manifold advantages. These are some of them:

o  Organizations can apply best practices relevant to their industry through audits

o  Audits help organizations to identify where they need to improve

o  Audits play a stellar role in ensuring the quality of products, which leads to enhance customer satisfaction

o  They help organizations to take preventive actions with which bigger problems can be checked

Most organizations think of audits as an unpleasant duty

Although internal and external audits are considered so useful; it is a fact that most organizations carry them out only because it is thrust upon them. Most companies lack the conviction and volition for an audit, and drag their feet when it comes to this important task. The many benefits of an audit program are usually overlooked by 75% of companies.

What happens to organizations that are not diligent when it comes to carrying out audits? They are sure to receive penal actions from the FDA, which range from Warning Letters, 483’s to penalties to Consent Decree.

Learning session on ways of getting internal audits right

In order to help organizations get their internal and external audits right, Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. The purpose of this session is to help professionals who need to carry out an internal audit for their organization, get it right.

The speaker at this seminar is Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc., who is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. Participants that want to get a clear and total understanding of the rationale for carrying out audits and of the ways for get them right can enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501303LIVE?Wordpress-SEO

An explanation of the ins and outs of auditing

Susanne will equip participants with the knowledge needed for audit professionals in organizations to put an effective and compliant audit program in place. She will help them understand what it takes to carry out a solid and thorough quality audit program that meets regulatory requirements by first being able to identify the red flags. This is the groundwork for understanding, reducing and communicating risks associated with quality and compliance.

Susanne will cover the following areas at this session:

o  Using a structured program to identify areas of risk leading to an effective audit strategy

o  How to develop a meaningful structure of audit, oversight, transparent communication, and escalation to management review

o  How to ensure your audit staff is well trained to proactively identify, communicate, and escalate issues

o  How a culture of quality and compliance can encourage clear and transparent communication of risk

o  How to prioritize, resource, and implement corrective actions

o  Tools for monitoring and communicating risk and improvement over time

o  How to identify residual risk

o  Monitoring and Controlling progress over time

o  Signs that your company culture is taking unnecessary compliance or quality risk

o  How to ensure management gets valuable information from your audit program

o  How to prioritize, resource, and implement corrective actions

o  Tools for monitoring and communicating risk and improvement over time.

Which Excel feature allows you to identify unlocked cells into which data can be entered

Mastering spreadsheet internal controls in MS Excel is a great way to make the most out of MS Excel. Unlocking these internal control features in MS Excel makes the program more efficient and powerful, and helps users derive more value out of its various applications.

Even though professionals in various areas, such as Accountants, CPA’s, CFO’s, Controllers, Excel users, Income Tax Preparers, Enrolled Agents, Financial Consultants, IT Professionals, auditors, human resource personnel, bookkeepers, marketers and government personnel, use MS Excel extensively in the course of their day-to-day work; they can still learn to improve and optimize the uses from MS Excel by learning more about it.

Learn the secrets of the power of MS Excel

This is what a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer at a highly interesting and educative webinar. This webinar will have David Ringstrom, an author and nationally recognized instructor who teaches scores of webinars each year, as speaker.

David’s Excel courses are based on over 25 years of consulting and teaching experience. He believes in the mantra: “either you work Excel, or it works you”. This is why he focuses on what he sees users don’t, but should, know about Microsoft Excel. His goal is to empower participants to use Excel more effectively.

It is this zeal the speaker carries into his teaching of MS Excel that will come into full play at this webinar. Interested in gaining from the wealth of experience that David brings into MS Excel? Then, just visit http://www.compliance4all.com/control/w_product/~product_id=501293LIVE?Wordpress-SEO to enroll.

Teaching from a simple standpoint

At this presentation, David Ringstrom will use a simple invoice form as a teaching aid to present various ways to control users’ actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes. What makes this presentation different is that the presenter will demonstrate every technique at least twice: first, on a PowerPoint slide with numbered steps, and second, in Excel 2016.

He will explain the differences in Excel 2013, 2010, or 2007 both during the presentation as well as in his detailed handouts. David will also give participants an Excel workbook that will include nearly all the examples he will be using during the webinar.

David will help participants with the following:

o  Discover how to use lookup formulas to find and access data automatically from lists

o  Apply Excel’s Table feature to future-proof elements of your spreadsheet.

o  Define how to use Excel’s Data Validation feature to restrict data entry to a list of permissible choices

o  Learn a custom shortcut for toggling the Locked status of a worksheet cell on or off

o  Understand how to preserve key formulas

o  Learn which Excel feature allows you to identify unlocked cells into which data can be entered

o  Learn a variety of ways to control users’ actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes.

David will cover the following areas at this webinar:

o  Using Conditional Formatting to identify unlocked cells into which data can be entered

o  Utilizing Data Validation to limit percentages entered in a cell to a specific range of values

o  Improving the integrity of spreadsheets with Excel’s VLOOKUP function

o  Toggling the Locked status of a worksheet cell on or off by way of a custom shortcut

o  Future-proofing VLOOKUP by using Excel’s Table feature versus referencing static ranges

o  Preserving key formulas using hide and protect features

o  Making it harder for a user to circumvent data validation and easy for you to identify when someone has attempted to do so.

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.

Understanding steam sterilization microbiology

Steam sterilization is an important means of killing microorganisms in microbiology. Sterilization is the method of removing all viable organisms from a source in a defined environment. Microorganisms are said to be dead when they are rendered ineffective by a decrease in their population in an environment. When they are unable to grow within their environment; they are considered dead. They don’t usually die the moment they are exposed to an agent that kills them.

Autoclaving is an important device used in steam sterilization microbiology. In addition to being used for sterilizing many devices such as surgical instruments, laboratory items and many more; an autoclave is also used in microbiology to sterilize microorganisms that cannot be killed by normal methods such as boiling and the use of strong detergents.

Autoclave qualification

The methods of steam sterilization microbiology need to be understood thoroughly, since they need to comply with regulatory requirements. An autoclave needs to be qualified for its performance, the basis for which is a proper grasp of stream sterilization microbiology.

Sterilization process parameters need to be laid out as a basis for conducting autoclave performance qualification studies. Exact standards of steam sterilization need to be met, whether it is to qualify a new autoclave installation or to continue maintenance of existing equipment.

A learning session on these methods

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.

The speaker at this webinar is Danielle DeLucy, who owns ASA Training and Consulting, LLC, which provides pharmaceutical and biologics-based companies with training and quality systems assistance that helps them meet regulatory compliance. To understand the way by which your steam sterilization microbiology needs to meet regulatory compliance standards; please enroll for this webinar by visiting Steam Sterilization Microbiology

A full description of steam sterilization microbiology

Since successful autoclave Performance Qualification depends on a thorough grasp of steam sterilization microbiology; Danielle will describe the steam sterilization mechanism as it relates to bacterial cells and endospores. She will explain the process and key terminology, because understanding these fundamentals is critical to develop a successful autoclave sterilization process.

She will offer regulatory references requiring use of air removal verification tools, chemical indicators and biological indicators. She will also explain definitions for sterility assurance level, accumulated lethality, temperature mapping and biological verification.

Quality Assurance Managers, Supervisors, Validation personnel and Sterility Assurance personnel will find this course useful. It is to meet the following objectives that this webinar is being organized:

o  Steam sterilization on a microbial level

o  Autoclave Performance Qualification expectations

o  Regulatory and GMP requirements for steam sterilization

o  Process verification tools for use in an autoclave Common questions, problems and cGMPs.

Danielle will cover the following areas at this webinar:

o  Autoclave Performance Qualification expectations

o  Regulatory and GMP requirements for steam sterilization

o  Validation tools for use in an autoclave

o  Common questions, problems and cGMPs.

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.