What Should be Included in a Calibration Program

One of the very important activities for a laboratory is calibration. The terminology found in 21CFR160 (b) (4) spells out the requirements for this aspect of medical devices. In addition, other terminologies and concepts that need to be applied for an effective calibration program, but are not found in the regulation, such as instrument classifications, also need to be taken into consideration.

Given this fact, it is important for professionals who work in laboratories to ensure that the laboratory has an instrument calibration program that assures that the instruments are calibrated at appropriate intervals using specific procedures that define the standards and tolerances that are relevant to and appropriate for the intended use of the instrument.

A well-structured learning session on calibration in the laboratory

All the core and supplementary aspects of laboratory calibration will be taught at a highly valuable learning session that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing.

At this webinar, Jerry Lanese, an independent consultant who focuses on Quality Systems and the components of an effective Quality System, will be the speaker. To gain complete understanding of all the important aspects of laboratory instrument qualification, please enroll for this webinar by visiting What Should be Included in a Calibration Program

Imparting understanding of the standards

The speaker at this webinar will show to participants how to apply measurement uncertainty or test accuracy ratio to specific calibration procedures, as well as the selection of standards needed to provide scientifically sound calibrations traceable to national references.

Building on the terminology found in 21CFR160 (b) (4); Jerry will base his teaching by relating and applying the concepts discussed to specific key instruments found in the testing laboratory. This learning will improve participants’ understanding of calibration and help them understand the ways by which to apply these concepts.

Jerry will cover the following areas at this session:

o  The regulatory and technical requirements for calibration.

o  What should be included in a calibration program

o  The importance of a data-based calibration interval and limits of accuracy and precision

o  The impact of measurement uncertainty when establishing limits of accuracy

o  The classification of test instruments

o  Current practices in the calibration of specific instruments

Laboratory Managers, Laboratory Supervisors, Laboratory Analysts that are responsible for the calibration of laboratory instruments, Laboratory Record Reviewers, Quality Assurance record reviewers and Quality Assurance Managers will gain important learning from this webinar.

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Who are involved in filing investigational new drug applications

Lack of data integrity or the presence of anomalies in data is one of the primary reasons for which the FDA hauls up and penalizes an organization engaged in pharmaceutical manufacturing. As the use of analytical methods for drug quantification at many stages of drug development process grows in prevalence; the need for scientists, technicians, and quality assurance personnel, etc. to understand the complete validation process of the analytical method has become all the more important and necessary.

The validation of a method used is all the more important when it comes to dealing with quantitative analysis of drugs in various biological matrices such as blood, serum, plasma, cerebrospinal fluid, urine, tissues, etc. Yet, many companies overlook these crucial aspects of validation that are outlined in FDA’s guidance, and end up receiving citations from this regulatory agency for these reasons. A company which receives these citations not only faces the prospect of delayed drug development; it can also dent and jeopardize the future of the drug’s regulatory acceptance.

Clear understanding of FDA guidelines for bioanalytical method development and validation

A complete and clear understanding of the FDA guidelines for bioanalytical method development and validation is necessary to avoid being in situations outlined here. It is to familiarize pharmaceutical professionals with this important aspect of the FDA guidelines for bioanalytical method development and validation that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar.

Venkata Kashyap Yellepeddi, who is an Assistant Professor of Pharmaceutical Sciences, College of Pharmacy, Roseman University of Health Sciences, Utah and Adjunct Assistant Professor, Department of Pharmaceutics and Pharmaceutical Chemistry, College of Pharmacy, University of Utah, Utah; will be the speaker at this webinar. Please register for this webinar by visiting FDA guidelines for Bioanalytical

This webinar will offer intensive and detailed understanding of the bioanalytical method development and validation for drugs and nutraceuticals outlined in the FDA’s guidance. This learning will add immense value to sponsors and analysts representing industries who are involved in filing any of the following:

o  Investigational new drug applications (INDs)

o  New drug applications (NDAs)

o  Abbreviated new drug applications (ANDAs)

o  Biologic license applications (BLAs)

o  Supplements in developing bioanalytical method validation information used in human clinical pharmacology

o  Bioavailability (BA)

o  Bioequivalence (BE) studies that require pharmacokinetic (PK) or biomarker concentration evaluation

Analysts involved in bioanalytical methods used for nonclinical pharmacology/toxicology studies and for the veterinary drug approval process will also find this webinar highly valuable.

Matching the FDA’s level of expectations

The FDA expects anyone involved in quantification of drug using an analytical method in any stage of the drug development to be well-versed with FDA’s guidance for bioanalytical method validation. With this assumption, FDA inspectors often ask questions on analytical method validation during routine inspections, and expect all personnel involved to be knowledgeable about the process of validation. This webinar will familiarize participants with these aspects of an FDA inspection.

Kash will cover the following specific areas during this webinar:

o  Chromatographic Methods

o  Ligand Binding Assays

o  Parameters involved in Bioanalytical Method Validation

o  Data Analysis, Statistics and Reporting

o  Additional issues in Bioanalytical Method Validation.

This course is of high value to those involved in one or another way with bioanalytical method development and validation, such as Chromatographers, Analysts, Chemists, Scientists, Formulators, Patent Lawyers, Technicians in Pharmaceutical and Veterinary Industry, and Contract Research Representatives.

What is the legal language of the FDA form 1572 or Device equivalent?

Form FDA 1572 is one of the primary documents needed when carrying out a clinical trial. Also called the Statement of Investigator; Form FDA 1572, called just 1572 informally, is a contract between the Principal Investigator (PI) and the FDA. This form contains all details of the subjects, as well as commitments from the PI.

It is a contract in which the Principal Investigator, the person who is in charge of the clinical trial, gives an undertaking to the FDA giving it the assurance that she will comply with all the requirements set out by the regulatory agency with regard to the trial.

By signing the FDA form 1572, which relates to IND studies, or the “Statement of the Investigator, which is meant for IDE studies; the PI is submitting herself to all the appropriate regulations, as this is a legally binding document by which they commit themselves to follow all of these.

The 1572 is meant to serve two important purposes:

It is a way of helping the FDA, as well as the sponsor of the study to qualify the PI, i.e., it gives the FDA and the sponsor of the study the opportunity to understand the Principal Investigator’s qualifications and ability to carry out the research in terms with the purposes it seeks to fulfil. It is also a way to verify that the site at which the clinical study is being carried out is appropriate for the study.

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The Form FDA 1572 also has another important purpose to fulfil.  It takes an undertaking from the Principal Investigator that the requirements set out by the FDA will be met during the trial. Failure to adhere to these commitments is considered a criminal offence, as something amounting to making false statements, and is liable for legal action under the terms set out in 18 USC 1001. This form has to be submitted whenever the sponsor selects the Principal Investigator to take charge of a clinical trial that is being conducted as an investigational new drug (IND) meets the criteria set out in 21 CFR 312.53 (c).

Other documents

Further, other documents such as 21 CFR 312.50, which deals with the General Responsibilities of Investigators, 21 CFR 812.100, which deals with the Responsibilities of Investigators for Biologics, and 21 CFR 812.110, which deals with the Responsibilities of Investigators for devices, need to be adhered to.

All these documents set out the general and specific responsibilities that the Investigators have when conducting a clinical trial. These start from who can qualify to be considered a PI to what qualification criteria sub investigators and research staff need to have.

A proper understanding of Form FDA 1572

FDA Form 1572 is thus an extremely important document that needs to be complied with fully if the clinical trial has to be considered compliant with the regulatory requirements. A full understanding of all the aspects that go into this will be spelt out at a webinar that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.

This webinar educates participants about the due diligence that investigators and their staff about their regulatory and legal responsibilities. Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena, will be the speaker at this webinar. In order to gain complete knowledge of this valuable guidance document, please enroll for this webinar by visiting signs the FDA form 1572

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There are nine statements in the FDA form 1572. Seven out of these begin with “I agree”. These are the important elements named in the 1572:

  • 21 CFR 50 (Protection of Human Subjects)
  • 21 CFR 56 (Institutional Review Boards)
  • 21 CFR 312 (Investigational New Drug Application/IND)
  • For Device studies, 21 CFR 812 (Investigational Device Exemptions/IDE) is added in place of 21 CFR 312.

The GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811 outline additional responsibilities. It makes sense for PI and sponsors to comply with the principles of Good Clinical Practices (GCP), and to also use their common sense.

Charles will give a proper understanding of all these at this webinar. He will cover the following areas at this webinar:

  • The Investigators role in the clinical research process
  • The difference between AEs and SAEs and the reporting requirements of the investigator
  • Why the investigator maintains a list of staff signatures?
  • Why the investigator files the signed and dated protocol?
  • Why the investigator is responsible for the IC process?
  • What is the legal language of the FDA form 1572 or Device equivalent?
  • Why is Financial Disclosure information important?

What is the history of the drug / device regulations?

Techniques to Follow Which Increase the Confidence in the Audit

Auditing is a very important aspect of quality in all the areas of the medical sciences. An audit is the most reliable and foolproof method for evaluating the extent to which the various activities in an organization comply with the requirements and expectations the principal has from those to whom various processes are outsourced. Audits are the main tools for a quality unit to monitor and ensure that those activities are performed in compliance with the manufacturer commitments for quality and regulations.

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An audit is also essential to ensure that the organization meets guidelines set out by the regulatory authorities. Its uses are more pronounced in areas such as medical devices, clinical research, pharmaceuticals, and other areas of the life sciences which require adherence to very accurate and rigorous standards of processes, procedures, quality and policies.

Further, audits are also conducted to assess the quality of material supplied by vendors, who could be from fields as varied as accounting to software to claims settlements to medical products. In this era of outsourcing, it is but natural to expect players in the healthcare industry to outsource several of their activities for a number of reasons.

An audit is extremely crucial in all these activities in the life sciences industry, because it helps to control quality and save costs and many troubles that could come up if the processes are not adhered to. Outsourcing only saves the manufacturer or the provider the trouble of having to do many activities by himself; it does not absolve him of the legal responsibility. The law is very clear on this: Whenever there is noncompliance with the regulatory guidelines; it is the principal, or the provider, on whose shoulders the blame squarely lies.

An audit is effective, but only if done rightly

It is for this critical reason for which audits have to be performed, both internally and externally. But then, an audit can fail too, if it is not done properly. In the field of medical sciences, there are well-established good practices and best practices in many areas, such as Good Manufacturing Practices, Good Laboratory Practices, and so on, but there is no such convention as a Good Auditing Practice. This makes the voluntary inculcation of best practices an imperative for professionals in the areas of medical auditing.

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This is of extreme importance considering that most areas of the medical sciences deal with human lives. A high value is attached to audit practices, as an error from any of them, such as Contract Manufacturing Organizations (CMO’s), subcontractors, and suppliers of many items can have very bad consequences.

 

A learning session on auditing of CMO’s

The concept of Good Auditing Practices may not have evolved yet, but guidelines, techniques, and practices are in place to ensure that the audit meets its requirements and fulfils its objectives relating to quality.

Want to explore the matters that go into making medical audits successful and how to audit CMO’s to ensure that the products and processes required in a number of areas of the life sciences comply with the regulatory guidelines? Then, a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will help you do this.

This webinar will have Eyal Learner, who is owner of ELC Consulting Services, which offers the pharmaceutical and medical devices industries support in all quality related issues, as the speaker. To gain insights into how to carry out audits and ensure an effective means of evaluating compliance with the objectives of the Quality System,  especially when it concerns suppliers and outsourcing operations like CMO’s, service providers, sub-contractors and raw materials suppliers; please register for this webinar by logging on to 3rd Party and Subcontractors

Helping auditing serve its purpose

At this webinar, Eyal will explain the vital purposes of auditing and the ways of ensuring compliance with the quality and regulatory standards set out by the regulatory agencies using the right auditing techniques. He will show practical aspects of auditing. Although auditing is based on set principles and is a well-planned activity; auditors have to contend with changes that keep coming up abruptly, unannounced.

Auditors need to be prepared for handling such situations, which is what Eyal will help understand. He will explain the audit techniques and skills needed in situations like this and show ways by which to make the audit to be successful and efficient. This course is particularly aimed at auditors, potential auditors and auditees working for the pharmaceuticals, medical devices, and API and Excipients industries.

Eyal will cover the following areas at this webinar:

  • Short regulatory overview on external audits
    • GMP Requirements
    • Types of Audits
    • Rights & Duties
  • Planning
  • Off-site Assessment
  • Prefaces to Audit Techniques
  • General Techniques
  • Specific Techniques
  • FDA’s Quality System Inspection Technique (QSIT)

CAPA and Follow-up.

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:

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  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.

7 Keys to Compliance Excellence that Form the Foundation for Any Excellent Organization

In any industry, compliance is everything; be it highly specialized fields such as the life sciences, healthcare, medical devices or non-technological areas such as food and clothing. Why do companies need to be compliant? It is simply because being in compliance with the required regulatory requirements helps the organization to achieve the most positive outcomes needed for a business:

  • It earns them a good reputation
  • Increases stakeholder and customer confidence
  • Augments the value of their products or services
  • Improves performance and operations
  • Maximizes profits
  • Guarantees that they adapt the right processes.

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Meeting the appropriate compliance requirements is mandatory for the regulated industries. This fact is known, but the challenge is in implementing the measures needed for achieving compliance. A compliance program that is built into the organization’s processes and of which it is an inseparable part is the way to go about achieving compliance.

A very comprehensive term

Compliance is a very broad and huge term into which many aspects are built. Compliance has to be shown at all levels by an organization if it has to achieve its outcomes and help the organization fulfil its business and other objectives. Many organizations are somewhat lackadaisical in their approach to compliance, thinking that it is an auxiliary function and not a core business activity. They cannot be more mistaken.

It is more than just a duty that needs to be completed to satisfy regulators. An organization should strive to reach levels of excellence in compliance. Those who fail to do this are not aware of the colossal opportunity they miss to stay ahead of the competition. Excellence in compliance opens the key to several unimaginable opportunities. It leads to high levels of positive results. Achieving levels of excellence at compliance standardizes and optimizes processes and makes them safe, reliable and efficient.

Understand how to achieve excellence in compliance in all its depth

Want to understand how to achieve this in all detail? Then, you could enroll for a highly educative and informative webinar on this topic that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing. Please register for this webinar by visiting Achieving Compliance Excellence

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Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm that works with both domestic and international clients designing solutions for complex training and documentation issues and is celebrating its twentieth year in business in 2017; will be the speaker at this webinar. A regulatory and management consultant and an Instructional Technologist for 30 years; Charles has published numerous white papers on various regulatory and training subjects.

Seven keys to compliance excellence

At this course, Charles will explain the seven critical keys to achieving compliance:

  • Understanding the regulations that pertain to one’s industry and business throughout each level and function of one’s organization
  • Defining the critical processes relative to the regulatory path that has been chosen
  • Developing sound regulatory documentation
  • Harmonizing processes and procedures between plants
  • Committing to and executing comprehensive technical training
  • Instituting a sound and effective complaint and investigations handling process
  • Managing performance up and down the line to the performance structure created. If it is not managed it will not be performed.

At this session, which will be ideal for Directors, Managers, Scientists, Technicians and Associates; Charles will cover the following areas:

  • Understanding the Regulations that Pertain to your Industry and your Business throughout each Level and Function of your Organization
  • Defining your Critical Processes and why that is important
  • The Benefits of Developing Sound Regulatory Documentation
  • Why Harmonizing your Processes is Critical to Consistency in Operations and Regulatory Compliance
  • Why Technical Training is Essential to every Aspect of Business Operations to include Meeting and Exceeding Regulating Requirements
  • Institute a Sound and Effective Complaint and Investigations Handling Process
  • Performance Management – the glue that holds everything together and Guarantees Acceptable Performance throughout the Organization.

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