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jyoti sunil


This blog is related to healthy recipes and some motivational stories and articles. I love to cook and write about emotions.

Driver Talent


With this software no need to worry about losing drivers again and again. Its Backup and reinstall feature can save your hours of searching and installing individual device drivers. It is specially designed to update, repair and manage drivers for all windows PC. This software is also known as Driver The Life. With driver updates regularly, it will keep your PC’s performance remain at peak and avoid the various errors and system crashed caused by drivers that are out of date.

Preclinical Toxicology & Safety and its core elements


Preclinical toxicology and safety occupies a position of eminence in a clinical research program. A study of preclinical toxicology and safety is absolutely important because this leads researchers to an understanding of what causes adverse effects. Adverse effects form the backbone of preclinical toxicology and safety, because they can come from any source of toxicology. Toxicology, which is the study of adverse effects, can happen from any source ranging from chemicals to biological agents, as well as physical, or the environment. So, preclinical toxicology and safety has to take safety into consideration both before the dose is administered in humans, and before clinical trials. Good Laboratory Practices (GLPs) relating to preclinical toxicology and safety A Good Laboratory Practice that relates to preclinical toxicology and safety is one that lists out regulations and practices that ensure data integrity from nonclinical studies. Since these are practices and conventions that have evolved over time; there are different GLPs prescribed by different regulatory bodies such as the FDA, the Organization for Economic Co-operation and Development (OECD) and the Environmental Protection Agency (EPA). In the US, the FDA prescribes preclinical toxicology and safety GLPs under 21 CFR Part 58. At its simplest, 21 CFR Part 58 requires preclinical studies to be compliant with GLP relating to: In vitro toxicology In vivo toxicology Animal models Very broadly, preclinical toxicology and safety requirements for each of these types of toxicology can be understood thus: In vitro Preclinical toxicology and safety relating to in vitro toxicology is used for screening and ranking chemicals and the study of cell and tissue. GLPs for in vitro preclinical toxicology and safety are centered on improving future study design/s. In vivo The purpose of in vivo toxicology is to establish a starting dose for clinical studies that is safe. So, GLPs for in vivo preclinical toxicology and safety are meant to offer information on a drug that spews the least toxicity. Animal studies Finally, preclinical toxicology and safety in animal studies are assessed to serve treatment outcomes better in humans by testing drugs on animals. This is based on the assumption that these organisms serve as a proper indicator of how these drugs could act in humans. Read More: https://www.linkedin.com/pulse/preclinical-toxicology-safety-its-core-elements-ronald-gardner

Cleaning validation should have a policy designed to meet harsh regulatory requirements and principles


Compliance with the required cleaning validation regulatory compliance guidelines set out by the regulatory authorities such as the FDA, WHO, PIC/S and EU is essential for those who work in facilities which involve cleaning. The reason for which adherence to these regulatory guidelines is necessary is that these cleaning procedures need to establish and demonstrate verifiable standards of hygiene and safety. Quite naturally, cleaning validation regulations are built on highly rigorous, exhaustive and challenging principles. Many approaches and requirements Sound scientific principles and practices should be the basis for regulatory guidelines for cleaning validation. Cleaning validation, being risk based and reasonable, should consist of informed decision-making and thorough activity planning. To comply with cleaning validation regulatory guidelines and scientific principles; very precise concepts such as how to determine the residues to be targeted, ways by which to select the right analytical and sampling methods, how to determine the appropriate limits in various pharmaceutical and biotechnology processes and knowing by what means to establish scientific rationales that are acceptable to regulatory inspectors, need to go into cleaning. Lots of processes need to go into cleaning validation These concepts should ideally lead to the development of a general policy, i.e. a “Cleaning Validation Master Plan”, into which the appropriate documentation for each study needs to be performed. Awareness of the requirements for maintenance of the validated status is necessary for those in charge of the cleaning validation program. They have to also keep the regulatory requirements and the latest industry practices in mind. Clarity on all these topics is the intent of a detailed, two-day learning session on the topic, “Regulatory Requirements and Principles for Cleaning Validation”, which is being organized by GlobalCompliancePanel, a well-known provider of regulatory compliance trainings. To participate in this seminar, simply log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900635SEMINAR?regulatory-requirements-Washington-DC. The Director of this learning session, Joy McElroy, Principal Consultant at Maynard Consulting Company, will clear all the doubts regarding cleaning validation and all its elements. Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification during the over 20 years of total experience she has had in the pharmaceutical and biotech industries, 12 of which have been as a consultant. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Contact Information: http://www.globalcompliancepanel.com/ +1-800-447-9407

Maximizing profits and patient outcomes during times of dwindling reimbursements


Shrinking professional services reimbursements from all insurance companies is a fact that all practices are facing. With patient footfalls falling and operating costs skyrocketing; there is a need for everyone to look at ways by which to generate additional revenue opportunities with their existing patient base and at the same time, maximize patient clinical outcomes.

Get your HIPAA compliance right in six simple steps


The most important element that Covered Entities and Business Associates must keep in mind while carrying out HIPAA audits is best summarized in the words of Jocelyn Samuels, the top Federal official in charge of HIPAA enforcement. To quote her own words, Covered Entities and Business Associates must ensure compliance through “... a comprehensive and thorough approach to assessing and addressing the risks to all of the Protected Health Information (PHI) they maintain”. Although Risk Analysis is mandatory; HIPAA audits of 2012 showed that as many as four fifths of health care providers failed to comply with this mandatory requirement. Covered Entities and Business Associates are under severe pressure to do a HIPAA Risk Analysis of all the PHI’s they maintain. Most of this, they are expected to do on their own. This explains perhaps just why 80% of health care providers failed to do the Risk Analysis, a fact discovered by the HHS. In fact, the incidence of HIPAA violations has been increasing so steeply that 2015 was sardonically referred to in HIPAA circles as the “Year of the Breach”. This fact leads to the next important point: higher and greater number of government enforcement and private lawsuits. Learn the ways of getting HIPAA compliance right in just six simple steps The above facts make it absolutely imperative for Covered Entities and Business Associates to get every aspect of the HIPAA compliance right, in the manner suggested by Jocelyn Samuels. This is precisely what GlobalCompliancePanel, a highly renowned provider of professional trainings for all areas of regulatory compliance, will be imparting at a two-day, in person seminar. To enroll for his event, just visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900616SEMINAR?master-HIPAA-compliance-six-steps-San-Diego. The Director of this highly meaningful and valuable seminar is the well-known expert on HIPAA compliance, Paul Hales. Paul’s credentials get augmented by the fact that he has, with a team of expert advisors and practical field testers, created a method of making all HIPAA regulations accessible to the everyday person. Paul’s method explains all the aspects of HIPAA in uncomplicated and simple language and carries the exact citations to each regulation. This method is directed at organizations’ legal counsel who may not be well versed or experienced in HIPAA, and will be a major part of this seminar. Major benefits by learning from the expert Organizations that are required to carry out HIPAA audits will gain enormously from this seminar. It will help them to save money, time, and research. Paul will discuss how Business Associates and Covered Entities can grow their practice and be compliant. His method will serve as the very foundation on which organization can implement their HIPAA Compliance Program. Most importantly, he will teach how they can grow what is most valuable to their business: Their patients. Paul’s HIPAA compliance method, which consists of six easy steps, will create a level of quality to the advice that the legal counsel provides. He will take participants of this seminar through a Risk Analysis for their organization and will also delve into the Privacy, Breach, and Security Rules as applicable to their particular organization. Contact Information: http://www.globalcompliancepanel.com/ +1-800-447-9407

Tightening carrier food safety issues can save costs for the food and logistics industries


The fact that between five and eight percent of current recall and shipment rejection issues happen within the cold chain food transportation sector, resulting in fairly high, but preventable financial loss is an indication of how much scope is there to contain seepage in the food and transportation industries. Is this happening because of lack of regulation? No. Rather, it is the lack of proper understanding of these regulations that is at the root of the problem relating to food pilferage. There is no dearth of laws. For instance, there are the Food Safety Modernization Act and the Rules on the Sanitary Transportation of Human and Animal Foods. In addition, for reference, there is also the “guidance” which the FDA previously published, which now has the power of law, being legally enforceable by many government agencies. Complying with these guidances and laws is the way forward for the food and transportation industries. All that is needed is to change mindsets, practices and operations. Inculcating this takes time, and comes about with proper professional training. Ways of implementing the guidances and rules This is what Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be imparting at a webinar. John Ryan, a Quality Systems professional who has worked for over three decades in a variety of industries globally and owns Ryan Systems, will be the speaker at this webinar. To enroll for this webinar, please visit http://www.compliance4all.com/control/w_product/~product_id=500995 This FDA recommended carrier food safety training course will highlight the problems that may take place in the process of food transportation. John will teach how to implement sound sanitation, temperature monitoring and quality controls, which can go a long way in preventing adulteration during loading, unloading and in-transit operations. Plenty to learn from This course will benefit professionals across the food and food transportation industries, such as Directors and Managers in Food Safety and Quality Personnel, food safety audit teams, perishables logistics personnel, compliance officers, food company CEO's, drivers of food carrying trucks, and food load and unload personnel in a number of ways and help them save avoidable expenses by implementing checks and controls along the food transportation chain. The following areas will be covered at this webinar: o FDA Sanitary and Temperature Controlled FSMA Rules o Definitions: Carrier, Container, Tools and Equipment o Preventive Controls Subpart G: Receiver Liability for Carrier nonconformance o Prevention versus Corrective Action o ATP o GAP Analysis o Pallet versus Case versus Container Temperatures o Temperature Measurement Technologies o Pallet Types o Sanitation Testing o Costs

Putting a well-rounded and comprehensive Quality Management System


Putting a well-rounded and comprehensive Quality Management System An efficient and effective Quality Management System (QMS) is a critical factor for the success of medical device companies. Having an effective QMS in place is absolutely necessary for medical device companies that have to satisfy the needs of all of their stakeholders. Further, an effective QMS is a means to ensuring that a medical device company’s products are safe and effective for its customers. A medical device company has to show compliance with the necessary regulations. It should also enable the company to successfully demonstrate that compliance to the regulators. At the same time, this QMS system also needs to be efficient to allow medical device companies to meet the needs of their business stakeholders and shareholders. Get the QMS right to show compliance It is necessary for medical device companies to know how to put in place a QMS that meets all these varied and complex requirements. When medical device companies get trained on how to get their QMS right from all these perspectives, there is very little chance of going wrong. To enable medical device companies get all the aspects of their QMS right; GlobalCompliancePanel, a highly renowned provider of professional trainings for the areas of regulatory compliance will be organizing a two-day seminar. To enroll for this highly interesting and useful learning session, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900651SEMINAR?FDA-concepts-medical-device-companies-San-Diego-CA. Suzanne 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 be the Director of this seminar. Concepts and characteristics of a good QMS Susanne will introduce participants to the Quality System Regulations and how they can be translated into a QMS that is both agile and rigorous when it comes to ensuring safe and effective products. She will give an understanding of the essential capabilities for managing an exceptional Quality System. Throughout the seminar, emphasis will be made on the regulatory expectations and how participants can translate these into their QMS. The ways of structuring and optimizing their QMS will be among the core learning areas from this seminar. The starting point of all these is Management Responsibility and a commitment to quality. In discussing the concepts of management responsibility, a culture of quality, and continuous improvement; Susanne will make this learning comprehensive and well-rounded. She will also explain the following at this seminar: o The tools and metrics needed for understanding the state of a QMS and ways of identifying and prioritizing opportunities for improvement o The four major Quality System elements that are emphasized by the FDA in their QSIT (Quality Systems Inspection Technique) inspections o Lessons learned from Recalls, 483s, and Warning Letters o Myths and challenges and how common problems can be avoided o Best practices that can be easily adopted. Susanne will cover the following areas at this seminar: o Expectations for Medical Device Quality Management Systems o Regulations o Quality Management System Structure and Processes o Lessons Learned o Myths o Challenges o Best Practices o Inspection Readiness Contact Information: http://www.globalcompliancepanel.com/ +1-800-447-9407

Identifying and resolving common issues in FDA Software Validation & Verification


Verification and Validation (V & V) are two important aspects of regulatory compliance for software. What all are needed for achieving this? The FDA, GAMP and others provide guidance in the methodology and documentation needed for this. This apart; consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V. The U.S. FDA has stated that software validation can only be risk-based. This applies to software: a) As-Product; b) In-Product, c) In Production and Test Equipment, and d) The Quality System. This webinar will take a look at these. A learning session to help understand the nitty-gritty of V & V To offer complete understanding of the topic of V & V for medical device software, Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a webinar. John E. Lincoln, a senior medical device and regulatory affairs consultant, will be the Speaker at this webinar. Just visit http://www.compliance4all.com/control/w_product/~product_id=500816LIVE/ to enroll for this highly educative session. All areas of the use of FDA, GAMP, and other models This webinar will address the use of the FDA, GAMP, and other applicable industry Software Validation, professional trainings, medical device software, organizing a webinar, software validation models. It will supplement these with the ISO 14971 model to structure, run, and document acceptable software validations. It will cover these areas: o Verification or Validation –Current Regulatory Expectations o The Project Validation Plan o Product Software Validation and Process/Equipment Software Validations –how they differ o When and How to Use DQ, IQ, OQ and PQ o ISO 14971:2007 Issues o GAMP Guidance o The 11 Key Elements of the Software V&V Model o “White box” and “Black box” Validations o ‘Real World’ Considerations

Understanding an audit management system


An audit management system can be understood as a set of audit systems that an organization puts in place to ensure that it meets its objectives. All organizations need to have their own audit management systems. An audit management system is a system that facilitates the management of its audit capabilities. We can understand audit management systems as being a set of processes and methods that an organization puts in place to manage its audit procedures. This is distinct and different from a management system audit, which is essentially an audit of the management practices of a corporation and is governed by provisions of ISO 19011:2011. The different varieties of an audit management system Back to audit management systems: These are the processes and systems whose audits relate to the organization's business and services. Hence, these audits have to address all the aspects of the organization's products and processes. So, to ensure this, an organization carries out three broad varieties of audits, although additional ones can be appended to them based on the organization's needs: Audit of the product The product audit can also include service, if the organization has a service to offer and not a physical product. Product audit involves an assessment of the company's products or services to ensure that they meet set requirements relating to quality, specifications and customer expectations and requirements Auditing of the process Another part of the audit management system; the process audit looks at the way in which the product or service was manufactured or delivered. This part of an audit management system takes into account a wide variety of factors such as the internal and external factors that go into making the product, the raw materials used, their quality, and other resources that go into the product and the methods employed to make these. Auditing of the system An audit management system also has to audit the system, i.e. the adherence to the company's vision and mission, policies, its ability to honor contractual commitments, its compliance with regulatory requirements relating to the environment, and so on. What is the need for audit management systems? Having its systems and procedures audited bestows benefits to an organization:

How is Process Capability Analysis of Extremely Non-Normal Data Done?


The most informative method for analyzing the data that results from QC, Validation, or Engineering activities is the calculation of the product's or lot's “reliability” at a chosen “confidence” level (where “reliability” means “in-specification”). Such calculations are relatively simple when data is “normally distributed”; but if the data is non-normal and cannot be transformed to normality, then there is typically no simple way to calculate a reasonably accurate level of reliability. In such a situation, the ideal method for determining reliability is called “Reliability Plotting”. The output of reliability plotting is a definitive statement that the given product or lot has a specific percentage in-specification and which conclusion can be stated with a specific level of confidence (e.g., 95% confidence of 99% reliability, or 90% confident of 93% reliability). Reliability plotting can be performed using an Excel spreadsheet and formulas found in almost any introductory statistics textbook. A learning session Process Capability Analysis A webinar that familiarizes participants with the concept of Reliability Plotting is being organized by Compliance4All, a very well-known provider of professional trainings for all the areas of regulatory compliance. John Zorich, Statistical Consultant & Trainer at Ohlone College & SV Polytechnic, will be the Director at this seminar. You can enroll for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501027LIVE/~sel=LIVE/~John_N.%20Zorich/~Process_Capability_Analysis_of_Extremely_Non-Normal_Data Reliability plotting in detail John will familiarize participants with Reliability Plotting, which is a graphical technique that is a standard method described in some reliability textbooks. The method is used primarily for data that is problematic in one or more of the following ways: non-normal (e.g., a Fatigue-Life distribution), a mixture of distributions (e.g., the distribution looks bi-modal when arranged into a histogram), low precision (e.g., a large number of identical readings in a small sample size), and/or incomplete (e.g., when a study is terminated before all on-test devices can be measured, due either to measurement equipment limitations or due to time limitations). Reliability plotting can easily handle all such situations. This method involves first creating a probability plot (Y = %cumulative vs. X = raw data). That step and all subsequent ones can easily and automatically be performed using an Excel spreadsheet. At this webinar, John will cover the following areas: o Definitions o How to create a reliability plot o How to use it to determine reliability o Example, using typical data o Exact vs. Interval plotting o Examples using data from: mixed distributions, highly replicated values, or censored studies o Comparison to use of K-tables, etc.

Assessment-based prediction is an effective tool for hiring the right candidate


Undoubtedly, hiring should rate as being among the most important activities for an organization. This is so because it is through this process that the organization takes in its most important resource –people. At the time of hiring, as well as while considering promoting, HR and the other important decision makers need to make up their mind by asking critical questions with which to make predictions about a potential hire. These questions could relate to how well the resource can perform in the assigned role, for how long the resource could stay in the organization, and making an assessment about the person’s ability to handle more responsibilities. Not all HR and other hiring managers could be right all the time in predicting the outcomes of their actions about a candidate; yet, a good understanding of principles of assessing the candidate, combined with proper preparation and inculcation of a little disciple will go a long way in helping them become more accurate in their predictions. When the hiring managers are not too way off their mark in predicting the attributes of a useful hire, they are more likely to get a better candidate and avoid much of the unpleasantness that a bad hire can cause. Learn the art of predicting the usefulness and relevance of a candidate It is to equip participants with the tools needed to design a process for selecting and promoting for any position across any industry that a two-day, in person seminar is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. Harry Brull, who is President, Laurdan Associates, Inc. and Co-Founder of BCG Consulting Group, will be this seminar’s Director. To get an understanding of how to get the right insight into a selection process that is relatively error-free and effective, just log on to http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900717SEMINAR to register. Insights into getting the hiring and promoting process right At this seminar, Harry will explore the use of standardized instruments in designing and using simulations for maximizing return on references. This is in addition to the most often-used selection tool, the pre-employment interview. He will also discuss other important areas of the hiring process, like defensibility and avoiding complaints from unsuccessful applicants, ways of judging a candidate’s interpersonal skills, other capabilities and motivators, and other factors which determine whether there is a good fit between the individual, the position, and the organization. In addition, Harry will also look at adding other selection tools such as testing and simulations (job samples) to the selection tool mix, which can greatly improve prediction accuracy and provide an alternative view of candidate skills, and techniques which improve the usefulness of reference information, including eliciting vital information from sometimes reluctant sources. Harry will cover the following areas at this seminar: o The big-picture look at selection/promotion o How to analyze position and organizational requirements o Effective recruiting o Designing and using screening tools o How to design and conduct high-yield interviews o Adding testing and simulations to the selection toolbox o Avoiding legal problems o Maximizing return on reference inquiries o Putting it all together - designing a selection process.

Risk of omission is a critical one in Quality


Omission is a very important, but often overlooked aspect of Quality. It is often not realized in most organizations that the risk not doing a thing right, or what may be termed risk of omission, usually outweighs and is far more dangerous than the risk of what they do wrong, or what is a result of poor quality. The best way to understand the importance of this paradigm is that poor quality generally comes out or makes itself known during inspections and tests, or when customers complain about it. These internal and external aspects are indicators of poor quality and show up, but the element of risk of omission does not have this option. The silent killer However, omission, on the other hand, is a silent killer, spotting which is extremely difficult. Who would have known, for instance, until Frank Gilbreth's non-stooping scaffold demonstrated, that such a quotidian practice as bricklaying, which was being practiced by man for millennia, was being done in such a way that the normal practice was ending up wasting an amazing two thirds of the worker's labor on non-value-adding motions? It is when organizations equip themselves with the extra capability of spotting omissions like this that they stand out from the rest of the crowd and become world class performances. The ability to locate these otherwise invisible risks and opportunities is what distinguishes them from the rest. Imbibe the skill for identifying the hidden The ken for spotting this kind of small aspects should be cultivated into organizations. A hint of the ways of doing this will be the focus of a highly relevant and interesting webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. William Levinson, who is the principal of Levinson Productivity Systems, P.C., will be the speaker at this highly perceptive session. All that you need to do to enroll for this webinar is to visit http://www.compliance4all.com/control/w_product/~product_id=501033 to register. Echoes in ISO ISO 9001:2015 Clause 6.1 requires “actions to address risks and opportunities” with regard to the “context of the organization” and “needs and expectations of interested parties”. The standard also cites the SIPOC (Supplier, Input, Process, Output, and Customer) model, but the scope of this principle is not wide or deep enough to cover many existential risks and opportunities. The examples of Kodak, whose innovation outdated its own top selling product, and Toyota production system's Seven Wastes show application of this ISO 9001 approach focuses only on one particular risk –the palpable one –while many more, far more potent ones could be lurking in the shadows, so to speak. This leads to corrective and preventive action (CAPA) to remove the root causes of the problems in question. It is in dealing with the asymptomatic risks that organizations have to sharpen their nous. An organization that fails to do this loses opportunities to grow and be the leader. Looking beyond the obvious This webinar will offer some insights into the ways of doing this. The speaker will bring to bear his accumulated experience to narrate ways by which organizations need to look beyond the obvious in zeroing on the less conspicuous Quality issues. He will dwell on the four key performance indicators, as developed originally by Henry Ford, which make it very difficult for asymptomatic wastes to hide under. These are cycle time, waste motion, waste of materials, and waste of energy. It is physically impossible for the last two wastes to hide from what chemical engineers call a material and energy balance, and its application supports ISO 14001 and ISO 50001. Enormous waste, along with risk of interruptions, can also hide in the supply chain. These aspects will be explained in detail.

Ensuring sanitization of food products


Maintaining clean conditions in the entire food operation is essential for ensuring effective sanitation in the food industry. This can be brought about only when the residual microorganisms are destroyed after the production, storage and service areas of food establishments are cleaned thoroughly. washing-tomato-2500Ensuring a microorganism-free environment is a huge challenge for those in the food industry. This is because activities related to food, such as food production, handling, preparation techniques and eating habits are constantly undergoing change all the time. These changes make food establishments very susceptible to microbial proliferation. Microorganisms are strong sources of foodborne illness. Those in food processing and foodservice need to inculcate best practices relating to sanitizers, which are essential for ensuring that food is clean and free of contaminants. A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will shed light on this crucial aspect of the food industry. To understand the ways of adapting the right means to fight contamination and prevent infection and disease, just log on to http://www.compliance4all.com/control/w_product/~product_id=501023 to enroll. The speaker at this webinar is Norman G. Marriott, Food Scientist Professor Emeritus and food Industry Consultant. Norman has been teaching university courses related to sanitation and food science, especially meat science for nearly four decades now and brings that rich experience into this learning session. A complex trail The food trail is a complex and very vulnerable one. Any food establishment environment that does not have effective preventive measures to arrest microbial proliferation can attract pathogenic microorganisms, which in turn act as vectors of contamination and foodborne disease. With an increase in the journey from production to consumption that handling and modern processing methods have brought about; there is a corresponding increase in the possibility of microbial contamination, and subsequently, that of the possibility of microorganisms that cause foodborne illness. The use and application of sanitizers that destroy microorganisms is a reliable layer of protection for consumers from unsanitary food that can cause foodborne illness and with it, economic losses to the food industry. Using sanitizers right This webinar will teach participants the right ways by which to put sanitizers to use to ensure a safe food supply for consumers. The result of this learning is that it will help those in the food service industry understand the ways and means of creating improved sanitary conditions for food establishments. With this, they not only protect the consumers of their products against foodborne illness; they also safeguard and build their own reputation, which will lead to an increase in sales and net profits and lift their employees’ morale. Norman will cover the following areas at this webinar: Importance of sanitizing Description of sanitizers for food establishments Sanitizing techniques Advantages and disadvantages of sanitizers available for the food industry

Making Big Data big in terms of effectiveness


Our world today is unthinkable without data. We seem to be flooded by it. Day in and day out, the world processes trillions of bytes. Big Data seems to be everywhere and has compounded our already heavy reliance on data. But has this proliferation of data made any significant difference to our lives? Has it made our business decision-making any more effective or insightful? What has this surfeit of data meant in terms of usefulness and value? Does reliance on Big Data necessarily mean better business decisions? Making sense of data Translating tomes and tomes of this data into something that is useful is a big challenge in today's world. This is a capability that needs to be translated into tangible, competitive strength, if quality and compliance have to be improved. Data Management and Quality metrics are important tools that can help in a host of important functions such as forecasting, resource allocation, risk management, decision making, and continuous improvement. Susanne Manz, who is an accomplished leader in the medical device industry emphasizing on quality, compliance, and Six Sigma, will impart the insightfulness needed to make sense of Big Data to participants of a webinar that Compliance4All, a highly popular provider of professional trainings for all the areas of regulatory compliance, is organizing. In order to understand what perceptiveness can be inculcated into understanding and analyzing Big Data to aid in decision-making, just log on to http://www.compliance4all.com/control/w_product/~product_id=501044 to register. Absolutely useful aid in decision-making for management review Management Review, among the fundamental requirements of a suitable Quality System; relies on timely, accurate and complete information to make risk-based decisions. An organization that is immersed in data that leads nowhere in helping it with the critical information to ensure product safety and effectiveness has no use from this kind of Big Data. Organizations need to have not heaps of data, but what in it gives them the ability to measure to understand quality, compliance, and customer satisfaction. This is the test of the accuracy, completeness and timeliness of their data. The aim of this webinar is to help participants develop the data management processes that help them optimize their quality system efficiency and effectiveness. Susanne will cover the following areas at this webinar: o What metrics are needed for quality and compliance success o Sources of data o Analytics capabilities o Descriptive and Predictive Data o Structure and process for managing data o Data Governance o Data Preparation o Using data for forecasting, continuous improvement, and management review.

Putting in place food processes that facilitate traceability and recall


The Food Safety Modernization Act (FSMA) has strengthened the FDA’s enforcement authority. The FDA now has the authority to not only mandate product recalls; the records and information they may request to see have increased as well. What has also gone up is the FDA’s documentation review authority. Allergen mislabeling microbiological and foreign material contamination are the leading causes of Class I recalls. Given this fact, the need is for developing quality systems that result in good traceability and lessen the impact of a market withdrawal or even recall. Food organizations need to put in place a thorough traceability system that starts with the management team and includes the operators. Putting a comprehensive system in place This system should be a comprehensive one that must comprise everything from lot identification throughout the supply chain, to effectively reviewed recovery exercises. The teams in charge of these systems must be ready to quickly execute the plan in the event of an incident. All this should not only streamline the traceability of the product and its documentation aspects; it should facilitate the ease with which a product recall is monitored and followed up, which will help bring down the cost of communication, product return and disposal. This has become all the more important and necessary with the federal government expected to put in additional funding aimed at allowing even greater sampling and inspection of products and facilities from the start of 2017. Reducing recovery time for customers Given that brand confidence takes a hit every time an alert gets issued; not having a well-oiled traceability and recall mechanism could mean increasing the recovery time for customer sales following a product recall and eventually, losing the customer. All the nuts and bolts of putting a highly effective traceability system will be the topic of a highly useful webinar that is being organized by Compliance4All, a very accomplished provider of professional trainings for all the areas of regulatory compliance. John Ryan, a Ph.D. who has been involved in the quality profession on an international basis in a variety of industries Quality Systems spanning the manufacturing, food, transportation and Internet industries over the past 30 years, will be the speaker at this webinar. To enroll for this webinar, register by logging on to http://www.compliance4all.com/control/w_product/~product_id=500998 A comprehensive understanding of all the areas of traceability and recall Traceability could consist of quite a variety of potential applications ranging from simple case level bar code systems to more sophisticated satellite systems that include sensors for explosives and bacteria. John will explain these, along with test data from a number of these systems that will be shown in cross country and trans-ocean applications. He will also explore other elements of traceability, such as farm, distribution center, blending operations, and pallet level vs. container and case level systems. John will explain the requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls. All the associated important areas of information such as identification, classification and protocols, and the technologies that are used at various price levels for tracking and recall, will be covered. More technological aspects, such as an integrated food safety system model that uses traceability, food safety and recall data to demonstrate how computer technology can be used to reduce the time to recall products and reduce the impact to human health, will be discussed. The model is based on the FDA FSMA concept for risk reduction and uses predictive modeling to point investigators in the right direction in the minimum time. The following areas will be covered at this webinar: o Self-reporting, Trade and Consumer and Classes of Recalls o FSMA expanded authority to stop and seize o Product and Process Vicarious Liability o Traceability standards, controls and practices o Overlooked transportation issues o ISO 22005 traceability standards o Current trends and common issues o Lot Identification at the case, pallet and container levels o Recall Classifications.

Controlling pests in food processing and foodservice


Food establishments continue to be a major source for pests due to the changes brought about in the means and ways by which food is produced and handled and in the ways of preparation techniques and eating habits. The pests in turn are sources for illness-causing microorganisms. The more knowledge about pest control at their disposal; the better it is for food processing and foodservice personnel, because this is essential for ensuring a safe food supply for consumers. Pests such as cockroaches, houseflies, rats, mice, and birds are the main sources for foodborne illnesses. To bring about a clean and disease-free food supply chain, their entry and eradication from infiltration into food establishments has to be ensured. Tracking and preventing foodborne illness is among the first steps food establishments need to put in place to achieve this. A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show the ways by which do to this. Norman Marriott, who is a senior Consultant in the food industry, will be the speaker at this webinar. Participants can gain the full benefit of the speaker’s rich experience by registering for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501024 This webinar is valuable for food processing and foodservice personnel such as Foodservice Managers, Food Processing Supervisors, Workers, Food Business Owners, and Food Safety Professionals in helping gain knowledge of ways by which to implement pest control measures and thus ensure sanitary conditions for food establishments. Controlling pests is important and useful for food establishments Effective pest control practices are essential for protecting consumers from unhealthy food that can cause foodborne illness and economic losses to the food industry. Thorough educational information about how sanitary conditions for food establishments can be improved enhances the foodservice organization’s reputation, protects against foodborne illness, and increases sales and net profits of food establishments. When this is achieved; employees’ performance goes up, and with it, their morale. Highly energized and motivated employees enhance and improve customer satisfaction. Norman will cover the following areas at this webinar: o Sanitary facility design o Description of pests found in food establishments o Pest prevention techniques o Pest eradication techniques.