Understanding HACCP and risk based HACCP

Hazard Analysis and Critical Control Point (HACCP) is an important system aimed at bringing down the risk of safety hazards found in food consumed all over the world. It is an internationally recognized system. When it was enacted in January 2011 as part of the FDA’s Food Safety Modernization Act; it was considered a very sweeping piece of legislation for the food industry.

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Identification and control of potential hazards at specific point of the food chain is the soul of an HACCP system. The chain starts with production and ends with consumption. Identifying and controlling these hazards at every point of the chain is challenging in today’s world in which food has become completely globalized.

HACCP suggests the putting in place of mechanisms to control and counter the biological, chemical or physical hazards that could be present or be a potential presence in the food. The HACCP system is designed in such a way such that a company that manufactures, processes, or handles food products in any form can use HACCP for eliminating or minimizing food safety hazards present in its product to acceptable levels.

Implementation is based on two approaches

Proper implementation of the HACCP program involves food companies to implement both these:

  • Prerequisite programs
  • Implementation of HACCP plans

Prerequisite programs:

Prerequisite programs are those programs that a food organization has to put in place at its facility to ensure that all the processes that go into preventing contamination, ensuring a hygienic environment, and the optimal and scientific use of manufacturing methods and technologies and the cleanliness and hygiene of the staff involved in the production of food are proper and compliant.

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Implementation of HACCP plans:

If the prerequisite programs are required at the manufacturer-specific location; many steps and processes need to go into ensuring the quality standards of food that goes out of the facility. HACCP has suggested as many as seven steps for food is free from contamination. These are part of HACCP plans.

 

 

 

These include:

  1. Conducting a hazard analysis
  2. Identifying the critical control points
  3. Establishing a maximum or minimum limit for temperature, time, pH, salt level, chlorine level or other processing characteristics that control the hazard
  4. Establishing Critical Limits
  5. Establishing Monitoring Procedures
  6. Establishing Corrective Actions
  7. Establishing Record Keeping Procedures and Verification Procedures

Risk based preventive control is a major component of HACCP

HACCP has placed a heavy emphasis on risk in the production and transportation of food. It requires risk based preventive control. Codex Alimentarius describes risk assessment as a scientific process that takes the identification of a hazard, its characterization, assessment of the exposure to it, and characterization of risk into consideration.

Risk assessment is part of risk analysis, which in turn is described as a process into which three aspects, namely risk management, risk assessment and risk communication go. So, HACCP requires food manufacturers and transporters to take the risk causing factors into consideration at work. All these become part of risk based preventive controls.

Get the confusion cleared in implementing a risk based HACCP program

To clear the confusions in the meaning of these terms and to teach the ways of implementing them, Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar.  This webinar will clear the misunderstanding between these terms and show ways by which to implement a risk based HACCP program and ways of getting it right.

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Rotimi Toki, who is principal of Rottoks Food Safety Management Consulting Services Limited, will be the speaker at this webinar. Rotimi has provided services to some of the top brands in food service and manufacturing sectors and specializes in Quality Systems Audit, developing an integrated food safety management system based on HACCP principles. In order to gain complete understanding of the ways by which you can adapt and implement a risk based HACCP program, please register for this webinar by visiting Background of The HACCP system

Step-by-step method of developing an HACCP program

Rotimi will present a step-by-step process for developing an effective HACCP program. He will elucidate the principles and specific steps needed for this, for this is a prerequisite to building such a program. Through this process, Rotimi will show how participants can build a plan that can identify and control food safety hazards and risks specific to their product line and processes.

He will show how to determine the significance of these hazards by applying risk assessment techniques, from which a measure of risk can be obtained. This measure allows users to put appropriate control measures in place. He will clarify on the various confusions and weaknesses present in many food safety standards surrounding the determination of control measures required by HACCP.

Rotimi will cover the following areas at this webinar:

  • Background of The HACCP system
  • The CODEX Guidelines
  • Basic HACCP procedures
  • Assemble the HACCP Team
  • Describe product and identify intended use
  • Construct flow diagram and on-site confirmation of flow diagram
  • Hazard Analysis
  • Determining control measures in HACCP
  • Establish Critical Limits for each CCP
  • Establish a monitoring system for each CCP
  • Establish Corrective Actions
  • Verification procedures
  • Documentation and record keeping
  • Post-HACCP Maintenance

Writing error-free procedures while complying with GMP regulations

In the area of GMP regulations, procedures are very vital, for both execution and audits. It is always true that the greater the clarity and comprehensiveness with which these procedures are written; the easier it becomes for users to use them without missing important information for regulators.

Despite the advent of technology into almost all the areas of GMP regulations; there is still the existence of the human factor. It is still the major culprit when it comes to losses that many industries sustain in their quality and production. Technology has pervaded most industries in ways that were not imaginable a couple of decades back; yet, it is not likely that human error will ever be totally eliminated.

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Having said this, it is also true that it is possible to prevent several human performance problems. The starting point of human errors start is the design stage. Human reliability comes into play in a major way in procedures. The key to human engineering, improving and/or fixing and identifying exactly where the weaknesses in the procedures instructions lie is getting a grasp of human behavior and the psychology of error.

A learning session on all the aspects of writing for GMP regulations

An understanding of the weakness in procedures that harm productivity, quality and regulatory standing will be the major 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 Ginette Collazo, a human error and human behavior expert, who brings vast experience in the technical training, organizational development and human reliability areas. Interested in gaining insights into how to understand and reduce human errors in GMP procedures? Then, all that you need to do is to register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501285LIVE?Linkedin-SEO

Discussion of all the areas of human error in writing for GMP regulations

At this webinar, Ginette will discuss everything from content development to formats designed for human error reduction due to procedures. She will start with an outline of SOP writing and describe the role and possibility of human error in content development. She will also discuss the universal purpose of procedures in the background of regulatory compliance.

Ginette will expound the human perspective and the rational for procedure use and describe human error as a root cause. She will also explain the thinking and reading process and touch upon some common mistakes and causes.

Human error rates and measurement, the ways of creating and maintaining a procedure, as well as the goals of a procedure, will all be taken up.

Taking a glimpse at Good Procedure Writing practices

Another of the areas Ginette will traverse during the course of this very interesting session is Good Procedure Writing practices, during which she will dwell upon all its related aspects such as Terminology, Formats, layouts, mixed cases, steps content, common words, references, branching, conditional steps, the use of “Precautions”, “Warnings” and “Cautions”.

Finally, she will also explain procedure styles and the use of electronic information networks for procedure access. All in all, this promises to be a very educative and well-rounded teaching session. All the important people involved in GMP regulation and human factors, such as QA/QC Directors and Managers, Process improvement/excellence Professionals, Training Directors and Managers, those in Plant Engineering, Compliance Officers, Regulatory Professionals, people in Executive Management, Manufacturing operations Directors and Human factors Professionals, will all derive benefits in large measure from this webinar.

Effective cleaning validation procedures for analytical equipment

Regulatory agencies the world over have put in place stringent requirements for ensuring that cleaning validation procedures for analytical equipment are effective. Even if putting these practices in place involves expense and effort, it is worth the trouble, because the cost of noncompliance is much, much higher than that of compliance.

Noncompliance with regulations for cleaning validation procedures for analytical equipment has a serious consequence: Regulatory bodies such as the FDA could take highly punitive actions against companies that show noncompliance, leading to huge money penalties and huge loss of reputation and the customer base.

Taking the rights steps for ensuring effective cleaning validation procedures for analytical equipment

In order to ensure that cleaning validation procedures for analytical equipment is effective; manufacturing companies need to know how to take steps that ensure cleaning validation regulatory compliance, along with risk-based, reasonable and informed decision making and activity planning.

Individuals in management, who are involved in the development of cleaning procedures, cleaning validation programs and plans, need to have a thorough understanding of the FDA perspectives on cleaning validation and areas of concern during regulatory inspections. They need a sound grasp of the elementary principles of a cleaning validation program.

A webinar to make cleaning validation procedures for analytical equipment effective

The skills needed for being able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations will be the core of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this session, Joy McElroy, Principal Consultant at Maynard Consulting Company, who brings over 12 years of experience as a consultant, and over 20 years of total experience in the pharmaceutical and biotech industries and has extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, will be the speaker.

In order to gain full understanding of effective cleaning validation procedures for analytical equipment; just visit http://www.compliance4all.com/control/w_product/~product_id=501118?Wordpress-SEO to register for this highly valuable learning session.

Building bulletproof solutions

At this webinar, Joy will impart learning on the expectations different global agencies have of analytical equipment qualification. She will offer an understanding of how to develop a sound process validation program with which to develop and implement bulletproof solutions that are accepted, effective, and efficient.

This session on effective cleaning validation procedures for analytical equipment will also offer case study analyses, through which the best practices for providing thoughts and ideas to develop or improve the performance of participants’ current system will be examined.

Additional learning on instrument qualification and system validation processes

Another benefit the case studies presented at this webinar on effective cleaning validation procedures for analytical equipment is that they will help participants to explore how the management practices of their analytical equipment qualification/validation and process validation programs can either foster or impede their legal liability and the legal issues that arise from nonconformance with regulators and auditors. Learning on the instrument qualification and system validation processes will be another part of this webinar.

This webinar on effective cleaning validation procedures for analytical equipment will be immensely useful for professionals in the area of cleaning validation for analytical equipment, such as Senior Quality Managers, Quality professionals, Production supervisors, Validation engineers, Process owners, Quality engineers, and Quality auditors.

Joy will cover the following areas at this webinar:

o  Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product

o  Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections

o  Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations

o  Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies.

Establishing Latest Quality Systems in medical device and pharmaceutical industries

Establishing Quality Systems is one of the central aspects of a medical device and/or pharmaceutical organization. Establishment of Quality Systems is also a regulatory requirement, as set out by the FDA and the ISO.

The process of establishment of Quality Systems for FDA-regulated medical devices industries is set out in 21 CFR Part 820. Further, the ISO has its standard for how to establish Quality Systems in medical devices industries –the ISO 13485 standard –which has to be implemented as part of a manufacturer’s Quality Management System.

ISO 13485 primarily identifies and traces cleanliness in the area of work environment and helps to manage risks. Although it does not require alignment with 21 CFR Part 820 and other FDA QSR regulations; the two complement each other.

Flexibility individualizes Quality Systems

Despite the assignment of specific tasks from each of these standards for establishing Quality Systems; there is an element of flexibility, because what precisely determines a Quality System varies from one firm to another, based on its values, mission and culture. In these cases, what medical device and pharmaceutical companies are required to do is to define and frame their own Quality Systems and then link them back to appropriate FDA definitions.

This is of critical importance, because when an individual Quality System is framed uniquely for an organization and is not aligned to the respective FDA definition; it makes the company’s regulatory inspections preparedness difficult and laden with impediments. This is one of the fundamental aspects of compliance with FDA regulations.

Professional learning on implementing the right Quality Systems

How do medical devices or pharmaceutical companies build Quality Systems that are effective and are traceable to relevant FDA regulations? The ways of doing this will be the core of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Louis Angelucci, who is a pharmaceutical professional and Certified Quality Engineer with over 20 years of experience in Quality Assurance, Quality Control, Validation, consent decree remediation, will be the speaker at this webinar.

Want to gain complete knowledge of how to build Quality Systems that tie with relevant FDA definitions? Want to make sure that your Quality Systems pass FDA regulatory compliance requirements and do not invite penal actions from the regulatory body? Then, register for this learning session by visiting http://www.compliance4all.com/control/w_product/~product_id=501189?Wordpress-SEO

An explanation of regulatory requirements

During the course of this webinar, Louis will offer participants a perspective of the expectations of a Quality System as they apply to validation. He will also explain the requirements of regulations for the pharmaceutical and medical device industries.

At this webinar on Quality Systems, which will hugely benefit professionals such as QA specialists, Quality Systems Specialist, Managers and Operators, Louis will cover the following areas:

o  Regulatory expectation regarding Quality Systems

o  How to establish Quality Systems

o  Quality systems fundamental

o  FDA definitions

o  Fitting within the FDA puzzle

o  How to maintain and operate within a quality environment.

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/

http://qualitymanagementsystem.com/iso-13485-saving-lives-through-quality-management/

Works Quickly Meeting the FDA’s Quality and compliance requirements

Quality and compliance are vital issues for any medical devices company. Despite the fact that the FDA’s regulatory compliance requirements are the same across the industry; many medical device companies are shocked when they receive a 483, or a Warning Letter, or even a consent decree. Is meeting the FDA’s regulatory requirements something of a chance, which some organizations get by fluke and others don’t?

This is simply not the case. Quality and compliance are built into a medical device product. It is only that companies need to have the capabilities needed for meeting Quality and compliance requirements from a regulatory perspective. If medical device companies have to be successful in their endeavors in the future, they have to be adept at how to meet quality and compliance requirements set out by the FDA.

Quality and compliance to meet regulatory requirements

Why is this needed? Simple: If medical device companies do not meet regulatory requirements set out by the FDA; they are not likely to meet the quality requirements demanded of their products. As a result, apart from being unable to create products that appeal to customers, they could end up facing punitive actions from the FDA.

As said, meeting Quality and regulatory compliance requirements is not something of a gamble. Quality and compliance, which are the key inputs for meeting customer demands, can be fulfilled by putting a thorough process in place. These are capabilities a medical device company needs to have if it has to meet quality and compliance requirements and succeed in the market.

Learn the ways of meeting Quality and regulatory requirements from the expert

The method by which medical device companies can achieve regulatory compliance requirements and ward off punitive actions from the FDA will be taught at a very interesting and lively webinar from Compliance4All.

The speaker of this webinar, Susanne Manz, an accomplished leader in the medical device industry, who emphasizes Quality, compliance, and Six Sigma and brings extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will demonstrate just what medical device companies need to do in order to meet Quality and regulatory compliance.

To gain complete insights into how medical device companies can take the requisite steps needed for meeting quality and compliance requirements, please enroll for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501160?Wordpress-SEO

An explanation of the seven capabilities needed for meeting quality and compliance requirements

At this session, Susanne Manz will explain that there are seven capabilities that are needed for medical device companies to accomplish their aim of meeting Quality and regulatory compliance requirements. She will explain these and offer complete understanding of how the changing regulatory climate needs to be comprehended. She will show how to evaluate one’s capabilities to develop a regulatory strategy that will help companies meet their requirements, so that they become successful in the pursuit of their objectives.

Susanne will show how to develop strategy from one’s self-awareness of the Quality and regulatory requirements. At this webinar, she will cover the following areas:

o  Evolving Regulatory Climate

o  Seven Key Capabilities for Success

o  How to evaluate and map your capabilities

o  Quality Planning and Improvement

o  Maturity Modeling

o  Developing Your Quality and Compliance Strategy.

Today’s Pre control and Statistical Process Control (SPC)

Pre control and Statistical Process Control (SPC) are key tools for determining the process that goes into a product.

SPC is a key ingredient of Quality. It is an important step in reducing nonconformities and defects in any manufacturing process. SPC charts help to detect assignable causes of a process change in a timely fashion. SPC helps to identify root causes and take corrective actions before the development of the product has reached such a stage that carrying changes out is neither practicable nor useful.

Examples of process changes that SPC helps to detect include trends, shifts and variation. Three items are needed for SPC to meet its goal:

o  A system that measures effectiveness in real-time

o  Tolerance that is practical and is connected to customer keenness and satisfaction

o  A dial indicator that comes with an anticipated response.

All these help SPC to determine whether a process is stable and requires no adjustment, is incapable of performing its functions altogether, or is deviating but capable.

And now, pre-control

Pre-control, on the other hand, inspects the units and adjusts the process and the succeeding sampling procedures assuming where the measurements are placed in relation to the specification limits. The focus of pre-control is individual measurements.

It uses a set of probabilities, based on assumed distributions and the location of the process, to estimate where there is a justification for the process adjustments. Since decisions concerning pre-control are based broadly, i.e., on the area in which the measurements; it obviates the need for charting, as it is very responsive to the process signals right from the start.

SPC or pre-control?

There are arguments for and against the use of SPC and pre-control as an effective means of ensuring that the process is right and that it results in the desired quality for the product.

At a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, the speaker, Jd Marhevko, who has been involved in Operations and Quality/Lean/Six Sigma efforts across a variety of industries for more than 25 years, will explain all the aspects of pre-control. To hear her perspective of pre-control, please register for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501074?Linkedin-SEO

What makes this webinar special is that it has consistently ranked in the top 1-5% at previous conferences at more than five venues. It was featured in ASQ QMD’s special edition of the Quality Management Forum’s 2015 Spring edition (ASQ-QM.org). A webinar of this topic was provided in 2015 via the ASQ QMD Linkage Technical Committee to over 1300 respondents through the IMA and ASQ QMD.

Tools needed for pre-control

At this hour-long session, Jd will explain all the elements of pre-control in Quality. she will show to participants the way of drafting and creating a pre-control chart. She will run a process in which to model the next steps and decisions.

The aim of this session is to equip participants with the knowledge needed for reducing the complexity of the system and bringing about an improvement in the effectiveness and efficiency of their Quality Management Systems.

A session packed with interaction and practical application of principles

A major component of this webinar on SPC and pre-control is that Jd will share the result of case studies. The knowledge gained at this webinar can be applied immediately at their work in respect to the following:

–       Measurement System Analysis (MSA): Jd will conduct a high level overview of MSA. This will help the participants get a grasp of the need for putting an effective measuring system in place ahead of implementing pre-control

–       Cpk Overview: To help participants gain baseline capability in advance of implementation of pre-control, a high level Cpk overview will be conducted

–       Normal Distribution: The way in which the cumulative distribution function of the normal distribution is to be used for estimating and establishing the zones on a pre-control chart

–       Pre-Control Chart: Jd will show participants how to apply the concepts listed above with the use of a mock pre-control chart where the process will be demonstrated based on the “go/no go” zones that are established.

At this webinar, Jd will cover the following areas of pre-control:

o  Reduce process complexity and minimize risk

o  Increase affectivity of a Core Tool

o  Increase personnel compliance in proactive process management.

https://www.isixsigma.com/tools-templates/control-charts/using-control-charts-or-pre-control-charts/

http://www.symphonytech.com/articles/pdfs/precontrol.pdf

http://www.winspc.com/what-is-spc/ask-the-expert/400-pre-control-no-substitute-for-statistical-process-control

http://www.qualitymag.com/articles/86794-pre-control-may-be-the-solution

A look into the 21st Century Cures Act

Considered one of the most significant changes to be introduced into the American healthcare sector since the passage of the Affordable Care Act; the 21st Century Cures Act was one of the last legislative acts of outgoing president Barack Obama. Signed into law in December 2016; the 21st Century Cures Act seeks to strengthen medical research, foster innovation and accelerate the development of innovative treatments for chronic ailments such as cancer.

The 21st Century Cures Act aims at strengthening funding for the National Institutes of Health (NIH) by allocating over $ six billion to them. Of this, nearly $ five billion will go towards biomedical research funding. One of the highlights of the 21st Century Cures Act is the allocation of nearly $ two billion for the “Beau Biden Cancer Moonshot” initiative, which is in honor of the Vice President Joe Biden’s son, who succumbed to brain tumor.

A different take on health improvement

This approach is a significant one, considering that researchers from some of the nation’s best-known science universities depend on NIH funding for their research. Nearly two thirds of the major drugs that are in the market since 2000 have been the result of NIH research.

In addition, the 21st Century Cures Act will also have a major impact on mental health. This is one of the most notable features of this Act. It allocates over a billion dollars for addressing opioid and other addictions in the US, and the health-related complications that arise from them, which is a significant contributor to the fall in national health standards and productivity of the population in its prime.

Will the 21st Century Cures Act change the FDA approval process?

While addressing this core aspect of scientific research in helping to treat chronic diseases; the 21st Century Cures Act also focuses on another very critical point of medicines: The FDA. Since no drug can ever enter the market without FDA approval and the FDA approval process is very lengthy, expensive and cumbersome; the 21st Century Cures Act seeks to address this fundamental issue by suggesting changes into the approval process for new drugs, as well as medical devices.

Concerns and criticisms

Reservations have been expressed about the effectiveness of the 21st Century Cures Act. The main concern is that the regulatory approval process of drugs from the FDA could get diluted, causing a risk to the lives of the patients, thereby reducing the ability of the FDA to protect lives with its regulations.

There are many issues at stake in this highly important legislation. A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will discuss the prospects and downsides of this very important law.

At this webinar, John E. Lincoln, a very experienced medical device and regulatory affairs consultant, will offer a complete insight into the provisions of the 21st Century Cures Act. This webinar will be highly meaningful and useful for research institutions and organizations that are directly concerned and connected with the FDA and its administration of emerging technologies and general health. Enroll for this webinar by registering at http://www.compliance4all.com/control/w_product/~product_id=501213?Worpress-SEO

Analysis of all the major aspects of the 21st Century Cures Act

John will explain and analyze all the main areas of the 21st Century Cures Act. He will scrutinize how the Act will concern the FDA, the impact it will have on other areas of the Federal government, and the possible benefits and drawbacks for industries and research institutions that will get directly and indirectly affected by the Act, and the general public.

John will cover the following areas at this webinar:

  • The Act’s 3 Main Areas
  • Increased Funding for Medical Research
  • Speed the Development and Approval of Experimental Treatments
  • Overhaul Federal Policy on Mental Health Care
  • Stated Advantages
  • Concerns Expressed
  • What Has Happened So Far

http://www.foxnews.com/health/2017/01/24/how-21st-century-cures-act-will-save-lives-through-research.html