The role of validation in HACCP

The Hazard Analysis and Critical Control Point (HACCP) is a process control system that is aimed at identifying the points or areas at which hazards (dangers) may arise in the food chain. It prescribes strict measures for manufacturers and transporters of food products to prevent contamination and the resultant hazards. Control of hazards in the food chain has always been a need, but HACCP assumes added significance in today’s world, where globalization has made it possible for food to travel to hitherto unexplored parts of the world.

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While this development has increased the choices before the consumers of food; it also brings challenges in the form of having to maintain hygiene and cleanliness standards throughout the often long food chains, usually over long periods of time. HACCP is considered a path breaking system in that it looks at food hazards very holistically and comprehensively. It seeks to control the onslaught of major microbiological contaminants in food such as E.coli, salmonella, listeria and many others that could cause diseases.

Tackling contamination from all sources

HACCP adapts a comprehensive view of all the sources of contamination, and seeks to prevent risks to food from all sources, such as:

  • Microbiological
  • Chemical
  • Physical

In addition, it also prescribes steps aimed at putting in place a hazard control system that consists of seven important steps:

Hazard-Analysis-&-Critical-Control-Points

  1. Conducting a hazard analysis for identifying potential hazards that could enter the food production process
  2. Identifying the critical control points (CCPs), which are points in the process in which the potential hazards could occur and taking steps to prevent and control them
  3. Establishing critical limits for preventive measures associated with each CCP
  4. Establishing CCP monitoring requirements to ensure that each CCP stays within its limit
  5. Establishing corrective actions where monitoring shows that a CCP is not within the established limits. The aim of the corrective actions is to prevent public health hazards from occurring
  6. Establishing effective recordkeeping and documenting procedures to ensure that the HACCP system is working rightly. Documentation should show the ways in which CCPs are being monitored, as well as verification activities and deviation records
  7. Establishing procedures for verifying that the entire HACCP system is working and offering the desired outcomes.

Good intentions not backed by validation requirements  

The noble intentions behind the HACCP systems and the stringent and serious endeavors towards their implementation notwithstanding; one grouse that food experts have had of the HACCP till recently is that the validation aspect of these hazards has not been given the same importance as other factors. Validation has no doubt been a part of HACCP, but somehow, it has been sort of overshadowed by the emphasis on verification.

It is only of late that validation has been gaining in prominence as a control measure. Companies need to validate their products by properly designing and taking adequate control measures that are capable of controlling food hazards within the process.

Understanding the role of validation in HACCP

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A valuable learning session that will emphasize the importance of validation in the HACCP system is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Ruth Bell, a Food Safety/Quality and HACCP Management Consultant, Auditor and Trainer, who has worked on a number of projects helping organizations throughout the food chain to design, develop, implement and verify manageable food safety systems tailored to their needs, is the speaker at this webinar. Ruth is well known for her practical Quality and HACCP knowledge as an auditor, consultant and trainer. Please register for this webinar by visiting Food Safety Control Measures

Putting in place scientific validation measures

The aim of this session is to drive home the importance of validating food safety control measures to ensure food safety management system capability. Validation of food safety control measures is an essential measure in ensuring that a food safety management system will be capable of producing safe food and remains effective over a period of time.

Validating food safety control measures requires a theoretical examination of the scientific justifications for the control measures identified and practically challenging them to determine they will be suitable and capable of consistently achieving the required level of control to ensure safe food.  Ruth will dwell on these aspects in detail at this webinar.

This webinar is aimed at HACCP team members and leaders, technical/quality managers, food safety managers, as well as auditors of food safety and HACCP systems, and specifically for specialists in positions such as HACCP Team Members, Technical Managers, Production Managers, Engineering Managers, and Consultants.

The speaker will cover the following areas at this webinar:

  • Current Guidelines for Validation
  • Differences between Verification and Validation Activities
  • Components of Food Safety Management System Validation
  • Validation Techniques including SPC, Predictive Microbiological Methods, and Challenge Testing.

Understanding the way the FDA works in handling food imports

The FDA’s task is cut out when it comes to one of its core functions –that of regulating imports. With the US economy absorbing food imports to the tune of $ 49 billion every year and with its allied regulatory agencies overseeing an astronomical number of nearly half a million facilities in the US and abroad; the FDA is certainly in a most unenviable position.

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In view of the fact that these foods are imported from almost all over the world to be sold into the US market; the FDA has strict regulations for ensuring the quality of the food items that enter the US market. Its primary task is to ensure that the foods and food products that enter the US market met the rigorous standards it sets in relation to safety, sanitation, wholesomeness and labeling.

Coordination with agencies across the country

Considering this fact, plus the fact that over two thirds of seafood and more than a third of all the food items consumed in the US are imported; it is no surprise that the FDA has a varied number of agencies with which it coordinates and whose help it takes to carry out its functions. These are some of them:

  • Homeland Security                              12662901_f520
  • Customs and Border Protection
  • The FDA and the USDA
  • Center for Disease Control
  • Food Safety Inspection Service
  • Agricultural and Marketing Services
  • Food and Nutrition Services
  • The U.S. Department of Commerce
  • Department of Defense, and
  • The Federal Trade Commission (FTC).

In-depth understanding of the FDA’s work on food imports

Want to explore how to understand these agencies work in tandem with the FDA and want to ensure that your products reach US shores without hassles and get regulatory approval from the FDA? Then, you need to attend a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

The speaker at this webinar is John Ryan, who began Ryan Systems a decade ago and who has been involved in the manufacturing, food, transportation and Internet industries over the past 30 years. To enroll for this webinar and gain the immensely sharp insights John brings into the FDA’s thinking on food imports, please visit

http://www.compliance4all.com/control/w_product/~product_id=501359LIVE?Wordpress-SEO

Complete understanding of the FDA’s work on food imports

John will offer understanding of the ways in which the various agencies work with the FDA in respect to food imports. A deep understanding in this area is necessary for those who want to import food to the US and gain regulatory approval for their products, since they all work with the FDA at various levels.

He will cover the following areas at this session:

  • Global Food Markets drive new import food safety requirements
  • Review how the FDA’s Food Safety and Modernization Act (FSMA) are changing things
  • Understand “Prior Notice” requirements
  • Foreign Supplier Verification Program (FSVP)
  • Prepare for the Foreign Facility Inspection Program
  • Learn what is in the “Investigations Operation Manual” (IOM)
  • What can happen to your product when seized
  • Learn what other countries require for food import
  • Review the proposed rules for food safety and quality during transportation processes
  • Learn how much food and what food is imported from different countries
  • Understand what the Imported Seafood Safety Program includes
  • PREDICT & OASIS Systems
  • Other resources available to help you.

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.

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.

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.

How does the FDA scrutinize Promotion?

The FDA has strict requirements on the way promotion and advertising practices are to be implemented by the industries that it regulates. Section 906 of the Food and Drug Administration Amendments Act (FDAAA), which came into effect in 2008 and amended the section that pertained to this topic previously, namely Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FDCA); now requires that published Direct to Consumer (DTC) advertisements for prescription drugs should include the following statement printed conspicuously for all products including vaccines:

“You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.”

One of many requirements

This is just one of the many requirements from the FDA about promotion and advertising practices. Any individual or company holding an approved application for a drug will be panelized for making a false or misleading claim in a Direct to Consumer (DTC) advertisement about the pharmaceutical product.

Such an entity can be fined up to a quarter of a million dollars for the first such violation in any three-year period. This fine can go up to half a million dollars for each subsequent violation in any three-year period. Further, the FDAAA fixes different levels of penalties for biological products.

New requirements that reinforce existing ones

In addition, the FDA issued two Draft Guidance documents in January 2017. These concern communications made by device manufacturers about information that is contained in the labeling of these products. The nub of these Guidance Documents is that for FDA-regulated medical device companies to escape enforcement actions from the regulatory agency; labeling has to be consistent with the standards and expectations set out by the FDA. It lists out a number of factors the FDA takes into consideration to determine if the labeling meets the standards of consistency set out by it. These are some of them:

o  Indication

o  Patient Population

o  Limitations and Directions for Handling, Preparing, and/or Using the product

o  The recommended dosage or use regimen or route of administration

o  The potential for increasing harm

o  Safe and effective use.

The FDA has, in this communication also set out the factors that it does not consider as being in line with its idea of consistency in labeling and false claims:

o  Stage, severity, or manifestation of disease

o  Use alone versus in combination with other product(s)

o  Route of administration

o  Strength, dosage, or use regimen

o  Dosage form.

This makes the grasp and proper implementation of the FDAAA requirements absolutely essential if an organization in the FDA-regulated industries has to be free of enforcement actions from the FDA and subsequent penalties.

Learning session on how to get the dynamics of FDA scrutiny of promotion and advertising practices right

This is the important learning a webinar from Compliance4All, a highly acclaimed provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Casper Uldriks, who through his firm “Encore Insight LLC,” brings over 32 years of experience from the FDA. He brings the experience of having specialized in the FDA’s medical device program as a field investigator, a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health. To gain understanding and clarity on these areas of FDA scrutiny of promotion and advertising practices, enroll for this webinar by logging on to FDA Scrutinize Promotion and Advertising Practices

Anticipate the FDA’s viewpoint of consistency

Anticipating the way the FDA will view and interpret its advertising and the way it monitors this activity is critical for any company that makes a marketing launch. If it fails to do this right, it could land itself in trouble and invite expensive and reputation-damaging enforcement actions. Companies that come under FDA regulation need to have a perfect grasp of what they are doing with DTC advertising and should not leave anything to chance.

Companies have to keep up with the defined boundaries of DTC advertising and promotion if they have to avoid FDA scrutiny. If the FDA deems a DTC marketing campaign to be misbranding the product, it will not allow it to be marketed. This calls for more sophistication and novelty on the part of firms in their advertising methods and messages. Firms need to pay attention to all the components of their advertising in mass media, such as volume, images, the prominence and conspicuousness of information, the speed of the message, subliminal messaging and the core message.

Get all the factors right to avoid FDA enforcement

This calls for a proper understanding of what each component of the advertising attempts to accomplish and then evaluate the integrated message. Ironically, this range of factors arms the FDA with sufficient ammunition to determine the advertising as misbranding and term it illegal.  The speaker will suggest the ways of tackling issues like this.

Casper will talk about these issues in depth at this webinar. He will cover the following areas:

o  FDA’s approach to DTC advertising and promotion principles

o  FDA guidance and use of cognitive psychology

o  Types of violation for illegal DTC advertising practices

o  The role of sales and marketing departments

o  Executives’ legal liability.

FDA’s thinking behind 21 CFR Part 11 inspections

21 CFR Part 11 is an FDA regulation that deals with electronic records and electronic signatures. 21 CFR Part 11 has a set of FDA regulations that define the various parameters that need to go into electronic records and electronic signatures for them to be considered genuine, that is, for these records to have the same trustworthiness, reliability and equivalency as those of paper records.

Any organization has to comply with the requirements set out in 21 CFR Part 11 to ensure that they can be considered as being equivalent to paper records and handwritten signatures.

The following come under the purview of Part 11:

o  Biologics developers

o  Biotech companies

o  CROs

o  Drug makers

o  Medical device manufacturers

o  Other FDA-regulated industries, with some specific exceptions

In other words, the provisions of 21 CFR Part 11 apply to organizations the life sciences industry. The provisions of 21 CFR Part 11 apply to areas that come under FDA regulated areas of research, such as researching, carrying out clinical studies, manufacturing, distributing and maintaining products.

The FDA has spelt out its best practices guidelines with regards to 21 CFR Part 11. These cover the following areas:

–       The Standard Operating Procedures (SOPs) and controls that go into supporting electronic records and signatures, which include measures such as, but are not limited to security, Computer System Validation and data backup

–       The steps taken for ensuring the security of the computer system have audit trails for creating and tracking data values, which make electronic signatures reliable and trustworthy

–       Steps to show proof that the system works according to what it is intended to, for which validation and documentation should be offered. Into this, the feature of helping users determine when a system is not working as it is intended to is also built in.

Punitive actions from the FDA on the rise

Experience has shown that 21 CFR Part 11 is an area in which the FDA has seen a high number of citations and other punitive actions. In only the last three years, the FDA issued no fewer than 30 Warning Letters that saw Part 11 violations. These actions have concerned not only the core areas of 21 CFR Part 11, namely integrity, availability and security of data; but also to validation of software and computer systems.

These findings are the result of the FDA’s renewed efforts at inspection and enforcement of Part 11 requirements. What makes these facts about the FDA actions intriguing is that for most part, these citations are against the Predicate Rules, rather than against Part 11 per se. All this lends credibility to the belief that there is widespread confusion about what the FDA is actually looking for in its inspections.

A useful learning session on Part 11 compliance

If companies in the life sciences industry, who are subject to Part 11 inspections, have to avoid these citations from the FDA; they need to first of all get a clear idea of what 21 CFR means and the reason and the manner in which it is being implemented. They next need to understand the enforcement part of Part 11 inspections from the FDA’s perspective. A grasp of these matters will help them prepare their company for Part 11 inspections.

The ways of getting these aspects right constitute the core of learning session from Compliance4All, a highly popular and renowned provider of professional trainings for all the areas of regulatory compliance. At this webinar, Angela Bazigos, a highly experienced regulatory compliance professional who brings over four decades in the industry, will be the speaker.

To steer clear of the entire muddle behind the Part 11 compliance, just enroll for this webinar by visiting      http://www.compliance4all.com/control/w_product/~product_id=501346?Wordpress-SEO

In the process of giving a clear understanding of how to implement the provisions of 21 CFR Part 11 in a way that avoids actions from the FDA; Angela will be covering the following areas at this webinar:

  • 21 CFR 11 then and now: a brief history of 21 CFR 11 and what it looks like today
  • Part 11 Basics
  • FDA’s view of 21 CFR 11 Compliance
  • FDA Acceptance of Data: Electronic & Paper
  • Computerized systems and eData
  • Basis for Part 11 Compliance and purpose of protection and validation
  • Diverse nature of “source” and how to protect and preserve it
  • Purpose and goal of 21 CFR 11 BIMO inspection
  • Inspection of electronic records – BIMO
  • The 10 Deadly Sins that break compliance
  • Examples of 21 CFR 11 Citations
  • How to prepare your company for successful part 11 inspections.

https://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm

https://www.microsoft.com/en-us/TrustCenter/Compliance/FDA#