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.

img_assurance004

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.

haccp-infografica

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.

site-map-2011

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

Understanding GLP’s and their relationship with GMPs and SOP’s

Good Laboratory Practices (GLP’s) are a series of federal regulations passed in the US by the FDA under 21 CFR Part 58. In addition, Environmental Protection Agency (EPA) also has formed GLP’s both for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 40 CFR Part 160 and for Toxic Substances Control Act (TSCA) in 40 CFR Part 792.

Biotechnology concept

GLP’s are Quality Systems that relate to the processes and conditions that organizations carrying out nonclinical studies concerning health and the environment have to comply with. The objective of creating these processes and conditions is to ensure proper planning, performance, monitoring, recording, archiving and reporting of these studies. GLP’s are not just guidelines; they have the effect of a law.

The intention of framing GLP’s is that a minimum standard has to be established for conducting nonclinical laboratory research. This acts as the basis for research or marketing of products that are regulated by the FDA or the EPA. Typically, products that come under GLP’s include:

  • Animal food additives
  • Medical devices that are meant for human use
  • Biological products
  • Pesticide products
  • Human and animal drugs
  • Electronic products

Cosmetic products do not come under GLP’s.

An understanding of GMPs

good-manufacturing-practices-4-638

Good Manufacturing Practices or GMPs are quality assurance standards which ensure that consistency and control go into the manufacture of products and that these products are in accordance with their quality standards that are required for their Intended Use and in conformity with the Market Authorization or the specifications that the product has to have.

What are SOP’s?

Standard Operating Procedures (SOP’s) are detailed written instructions that are aimed at bringing about maximization of safety and efficiency in the operations of select types of organizations such as:

screen-shot-2015-09-14-at-13-35-01

  • Pharmaceuticals
  • Clinical research
  • Emergency response
  • Government
  • Power

 

 

 

 

How are GLP’s related to GMPs and SOP’s?

Do GLP’s, GMPs and SOP’s have a close relationship with each other? How are they, all being vital elements of the industries to which they relate, connected with each other? GLP’s have nothing to do with GMPs, but what about SOP’s? What is the nature of the similarities between these and what are their differences?

This will be the important learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer. At this webinar, the speaker is Joy McElroy. During the over 20 years of working in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, which has enabled her to write and execute Equipment Qualification and Validation Protocols for several well-known companies.

To comprehend the nature of the relationship between GLP’s, GMPs and SOP’s, please register for which webinar by visiting Associated with GMPs and SOPs

Comparison and differences between GLP, GMP and SOP

Professionals such as Quality Assurance Personnel, Quality Control Personnel, Research and Development Personnel, Regulatory Affairs Personnel, Project Managers, Manufacturing Managers, Validation Engineers, Internal Auditing Personnel, Microbiology Personnel and Auditors will learn everything from:

  • What GLPs are
  • Why they were created
  • The objective of GLP’s
  • How they relate and are associated with GMPs.

Joy will explain what GLP’s are and help participants understand and compare the differences with GMPs.

 

How to control those risks and monitor the effectiveness of the controls put in place

Overview of this session Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous risk management process can prevent serious problems and costs for your company.

risk-management-definitionIn this webinar we’ll cover:

  • Overview and Definitions
  • FDA Expectations
  • ISO14971 Regulation
  • Linkages to Design Controls, Production Controls, Investigations, and CAPA
  • Risk Management throughout the product lifecycle
  • Common mistakes
  • Best Practices

Why should you have to Attend The cost of poor product risk management can be staggering. Complaints, Medical Device Reports, recalls, and serious adverse impact to your customers can all result from poor risk management. And these types of problems expose you to regulatory inspections and citations. Many companies have even experienced class action law suits because of product quality issues. An effective program of risk management can help you proactively identify and mitigate product risks. A good risk management process can help you methodically identify, mitigate, and monitor risk throughout the product life-cycle.

These are the areas covered by the speaker Susanne Manz

  • Overview of the ISO14971 standard as it applies to medical device companies
  • Integrating the new standard with ISO 13485 as part of your overall QMS
  • Conducting a review of the intended use of your device
  • Stages of Risk Management as well as Tools and Techniques
  • Identifying hazards in your product or production process, and estimating their severity
  • Judging the probability that harm may occur from those hazards
  • How to control those risks and monitor the effectiveness of the controls put in place

By login with this Risk Management Techniques for Medical Devices

Which are the experts benefited by this session are as shown in the below

Risk-Training

  • Design Engineer
  • Manufacturing Engineer
  • Quality Engineer
  • R&D Personnel
  • R&D Project Managers
  • Quality Managers
  • Auditors
  • Regulatory Affairs Specialist
  • R&D Manager

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.

How to deal with dynamic source data and the “refresh” concept

Microsoft Excel comes with a myriad of tools such as sorting, filtering, and subtotal to manage large lists of data. Yet, when it comes to analyzing all that data and doing it quickly, the MS Excel PivotTable is a very useful feature. It is particularly important and useful when the user is required to quickly create a compact summary report (based on lots of data) without needing to write complex formulas or rely on lengthy techniques.

Excel

MS Excel PivotTable is very versatile. It is considered Excel’s best analytical tool because in addition to speed, it also comes with amazing flexibility and dynamism the data interrelationships that are being viewed can be changed. It is easier to put the PivotTable MS Excel features into practical use by actually getting down to work on it, rather than trying to pore through the instructions on the printed page, which is a visually-oriented feature based on displaying fields in different locations. It offers the ability to create a complete summary report with heaps of data in very little time without having to write complex formulas and rely on obscure techniques.

Learn about all the features and aspects of PivotTable from the MS expert

A complete learning on the numerous PivotTable capabilities and its many tools and features will be offered at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

excel-pivot-table-tutorial

Dennis Taylor, an Excel expert who has worked extensively with Microsoft products (especially spreadsheet programs) since the mid-1990’s and has taught hundreds of workshops and authored numerous works on this program; will be the speaker at this session. Just visit Excel PivotTables to register for this webinar and gain complete insights into the ways by which to put the full array of functionalities of MS Excel PivotTable.

Simplifying the use of PivotTable

The main objective that Dennis Taylor has for this webinar is to familiarize participants with the quickest and best ways to create PivotTables and Pivot Charts. These include the following capabilities:

  • How to compare two or more fields in a variety of layout styles
  • How to sort and filter results
  • How to perform ad-hoc grouping of information
  • How to use Slicers instead of filters to identify which field elements are displayed
  • How to drill down to see the details behind the summary
  • How to categorize date/time data in multiple levels
  • How to create a Pivot Chart that is in sync with a PivotTable
  • How to add calculated fields to perform additional analysis
  • How to hide/reveal detail/summary information with a simple click
  • How to create a PivotTable based on data from multiple worksheets.

He will cover these in detail. In addition, he will cover the following areas at this session on MS Excel PivotTable:

  • Pre-requisites for source data – preparing data so that it can be analyzed by PivotTables
  • Creating a PivotTable with a minimum number of steps, including the Recommended PivotTables option
  • Manipulating the appearance of a PivotTable via dragging and command techniques
  • Using Slicers to accentuate fields currently being shown (and which ones are not)
  • Using the new (in Excel 2013) Timeline feature
  • Creating ad hoc and date-based groupings within a PivotTable
  • Quickly create and manipulate a Pivot Chart to accompany a PivotTable

MS Excel users who are familiar with PivotTable concepts, but need expanded techniques to analyze lists of data are among the primary beneficiaries of this webinar, but anyone needing to know how to create PivotTables from multiple sources and use Slicers, Timelines, Calculated Fields, and Conditional Formatting will also benefit from this course.

Consider alternatives to AQL sampling plans

There are many alternatives to AQL sampling plans, but most companies are not aware of them to try to explore them. Acceptance Quality Limit, or AQL, is applied as a yardstick in most manufacturing organizations for assessing the quality of products they purchase. Its importance can be gauged from the fact that it is only after the Quality department is convinced about the product’s ability to meet AQL that the receipt is acknowledged and the payment made.

AQL

Understanding AQL

AQL, short for Acceptance Quality Limit, is the smallest, or worst, or lowest level of tolerable process means that can be accepted for the quality of product. It is the ratio or percentage level below which it is not possible to degrade quality to be termed acceptable.

Most medical device companies accept Acceptance Quality Level as a standard business practice and criteria for quality. The attribute sampling based on ANSI/ASQ Z1.4 and Zero Acceptance Number Sampling Plans developed by Nicholas L. Squeglia are the most common applications used by companies.

Are there viable alternative to AQL sampling plans?

Yes, these two methods mentioned above are very commonly used, but it does not mean that they are the best. These methods are effective, but are not sufficient by themselves. Medical devices need to be aware of a variety of methods and when and how to use them.

The ISO 9001 and ISO 13485 require companies to establish “processes needed to demonstrate [product] conformity”. The FDA’s GMP (21CFR820) also requires that “sampling methods are adequate for their use”. An FDA guideline further states that “[a] manufacturer shall be prepared to demonstrate the statistical rationale for any sampling plan used”.

Sampling Methods

An AQL sampling plan does not provide everything that is needed to meet either or all of those requirements. Using only Attribute sampling based on ANSI/ASQ Z1.4 and Squeglia’s Zero Acceptance Number Sampling Plans, it is not possible to actually “demonstrate” that an AQL sampling plan ensures product quality.

This is where “Confidence/reliability” calculations come in as alternatives to AQL sampling plans. They are a more comprehensive and effective way of assessing the quality of purchased parts. Making calculations using tables and/or an electronic spreadsheet becomes easier. Using confidence/reliability calculations to provide evidence of product quality is also simplified through this method. The statistical rationale for such calculations is easy to explain and demonstrate, which is why these calculations are considered strong and reliable alternatives to AQL sampling plans.

Get to understand everything about the alternatives to AQL sampling plans

An understanding of these alternatives to AQL sampling plans will be offered at 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 session is John N. Zorich, a senior consultant for the medical device manufacturing industry. To enroll for this highly useful webinar, please visit http://www.compliance4all.com/control/w_product/~product_id=501388LIVE?Wordpress-SEO

In-depth understanding of the alternatives to AQL sampling plans

John Zorich will explain the pros and cons of ANSI Z1.4, and Squeglia’s C=0 in detail. He will explain the areas in which these plans fall short of meeting regulatory requirements. He will offer real-world examples of how using such sampling plans leads to production of non-conforming product to augment the learning on the alternatives to AQL sampling plans.

The ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans, will be examined. As part of alternatives to AQL sampling plans, John will explain the advantages of “confidence/reliability” calculations. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is “Normally distributed”, the calculations are extremely simple. The speaker at this webinar will explain how “non-Normal” data need to be handled, and will providing the methods, formulas, and tools to handle such situations.

The webinar on alternatives to AQL sampling plans will conclude with a discussion of how one OEM manufacturer has implemented “confidence/reliability” calculations instead of AQL sampling plans for all of its clients. The speaker will offer suggestions for how to use “confidence/reliability” QC specifications instead of “AQL” QC specifications. The use of “reliability plotting” for assessing product reliability during R&D is also discussed.

The speaker will cover the following areas at this webinar:

  • AQL and LQL sampling plans
  • OC Curves
  • AOQL
  • ANSI Z1.4
  • Squeglia’s C=0
  • Confidence/Reliability calculations for
    • Attribute data
    • Normally-distributed variables data
    • Non-Normal data
  • Transformations to Normality
  • K-tables
  • Normal Probability Plot
  • Reliability Plotting.

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.

food-imports-and-exports-1

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.

How current regulations effect product development strategies

The life sciences market in Japan, consisting of pharmaceuticals, medical devices, biologics and combination products, is huge by the standards of the markets in the neighborhood, such as China, Malaysia, Singapore and Australia. It compares with those of Europe and North America. The main reasons attributed for this are the high spending power of the population, high number and density of the population, the aging population and the huge spending on the healthcare sector on R and D and innovation, which result in high costs that have to be passed on to the consumer.

developing-a-strategic-business-plan-13-728

At this point of time, Japan is going through developments that have the potential to cause tremors, if not turbulence, in the life sciences market, particularly that of drugs. The annual potential for only drugs is pegged at ¥ 150 billion. In the backdrop of high unit prices of drugs, the government is keen to actively pursue a couple of major initiatives.

One, it wants to cut the price of generics, so that they reach out to a larger market base. Two, it wants to bring about improvements into the regulatory framework by focusing on regulations that ensure higher and easier postmarketing safety. The Japanese regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), is stepping up efforts to make changes into their IT systems, which will streamline the processes for filing clinical data for regulatory approval.

Makeover of its image

The PMDA also plans to recruit more manpower to tighten the overall regulatory process and bolster innovation in this sector to take it to even higher standards than it currently is in. the main purpose for which the PMDA is pushing for all these is to eradicate the impression that has gained ground, especially among western life sciences companies, that Japanese regulatory processes are laggardly and not up to the standards that can be expected from a country of its developmental level.

It is in the backdrop of these contexts that understanding what it takes to make regulatory filings in the life sciences in Japan acquires significance. An in-depth understanding of this topic will be the content of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Robert J. Russell, who is President of RJR Consulting, Inc., which assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and Quality Assurance, will be the speaker.

To gain insights into how the regulatory filing requirements and compliance processes for Japan work, please enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501369LIVE?Wordpress-SEO

Insights into the regulatory scene

At this session, Robert J. Russell will familiarize participants with the regulatory compliance requirements and procedures for pharmaceuticals, medical devices, biologics and combination products in Japan. He will help participants get an understanding of topics relating to pre-clinical and clinical requirements, as well as with the structure of the regulatory agencies in Japan.

While elaborating on the current regulatory climate in Japan; the speaker will offer examples of effective compliance procedures and techniques. He will describe the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products and familiarize participants with a few common issues and concerns that professionals and firms dealing with Life Sciences usually face when they do business with Japan.

Japan’s utilization of the ICH standards

The speaker will also explain how Japan interacts with and utilizes ICH standards. He will also describe how Japan’s way of working with other national regulatory agencies influences their business. The webinar will show ways by which to address the conflicts that sometimes arise and suggest the optimal ways of doing this.

This course will provide insights into all the important areas of regulatory filing requirements and compliance processes for the life sciences in Japan. Its objectives are the following:

  • What is the Regulatory Structure in Japan
  • Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
  • How to begin your company involvement in Japan
  • How current regulations effect product development strategies
  • Pricing issues
  • Understanding the concerns/issues of Japanese Regulatory Personnel
  • Understanding the Local Culture: How to negotiate with the regulators
  • Information necessary for effective submissions
  • Maintenance of Authorized Products

This is the outline for the course:

  • Japan’s Regulatory Structure for the Life Science Product Industries
  • Beginning Your Company Involvement in Japan
  • Life Science Regulations and the Regulatory Processes in Japan
  • Japan’s Use of ICH Standards/Principles
  • Marketing Authorization Processes – Filings & Registrations
  • Variations: Changes to Marketed Products
  • Renewals
  • The Do’s and Don’ts of Regulatory Involvement