Implementing the 510 (K) correctly in compliance with the latest proposed FDA changes


A 510(K) is a premarket submission made to FDA to demonstrate that a device to be marketed is at least as safe and effective, meaning that which is substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA).

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

Medical products need to be validated for Radiation Sterilization


“Do it right the first time” should be the mantra for medical device manufacturers that plan to make radiation products. Choosing the most functional and radiation resistant materials for their medical device will help them avoid the trouble of going through the post launch cycle of product revisions. To get this right, one simple line of thinking is crucial for medical device manufacturers to inculcate: To “think like a molecule”. This is the basis on which to plan and design around radiation induced changes in the qualities such as color, odor and brittleness that go into the materials. Learning the right method Professionals in the medical devices industry, who work on these aspects will benefit immensely from a two-day seminar on the topic, “Validating Radiation Sterilization for Medical Products”, which is being organized by GlobalCompliancePanel, a highly popular provider of professional trainings for all areas of regulatory compliance. The Director of this seminar, Karl J. Hemmerich, President of Ageless Processing Technologies, who brings over 35 years of experience in medical device product design, development, manufacturing, and sterilization, will offer a range of learning on this topic. Identifying the best suited materials Apart from helping participants identifying the materials that perform best upon radiation, keeping color and odor out of their irradiated products and enhancing product and packaging designs to take advantage of radiation; he will also offer understanding to them on how to avoid the materials that are certain to fail. This seminar, for which medical device professionals can enroll by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900685SEMINAR?validating-radiation-Washington-DC, has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Understanding optimum sterilization modality Participants will also learn the basis for choosing the optimum sterilization modality based on materials, product design, bioburden, and logistics and understand which modality (Gamma, E-beam, or X-ray) will perform best for their product. Karl will cover the areas relating to validation of radiation sterilization for medical products, such as Materials Guidances - AAMI TIR # 17, ASTM, sterilization validation and bioburden, Shelf Life Test Methods - Accelerated Aging design, Test Design, Product Design, the influences of product assembly (molding, automation, etc.), material selection and post irradiation degradation, Regulatory Guidances - AAMI/ISO 11137, TIR #17, packaging design and materials, and biological polymers - tissue, serum at this two-day in person seminar. The following areas will be covered at this seminar: o Polymers Chemistry - choosing the best polymer candidate o Gamma, E-beam, X-ray sterilization o Accelerated Aging o Product Qualification o Sterilization Validation - Establishing the Minimum Sterilization dose (VDmax) o Sterilization Modality Selection Criteria o Biocompatibility o Preventing Plastic Part Failure Post Irradiation 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.

Elements of a Cyber Security Incident Response Program


A Cyber Security Incident Response Program (CSIRP) or a Cyber Security Incident Response Team (CSIRT) that anticipates and neutralizes a cyber-incident is a critical need for organizations, because an Internet or network security breach results in loss of valuable data, as well as several resources and the organization’s reputation and could potentially invite lawsuits. While putting a CSIRP in place; the management has to take into consideration the fact that Information Security, Governance & Risk, are all critical aspects of planning and execution of the Information Security Plan. It has to decide who in the organization has the key responsibility towards developing an information security governance program. It has to also review existing Information Security policies and standards to gauge their sufficiency vis-à-vis industry best practices, and update them as needed, while meeting the requirements set out by compliance regulations. A webinar to help understand CSIRP The effective ways of doing this will be the focus of a webinar that is being organized by Compliance4All, a highly popular provider of professional trainings for all areas of regulatory compliance. Dr. (Ms.) Michael Redmond, CEO and Lead Consultant for Redmond Worldwide, who served as an Adjunct Professor for Continuity Management at New York University and the Master’s program at John Jay College, will be the speaker at this webinar. More details of this course can be had from http://www.compliance4all.com/control/w_product/~product_id=500961LIVE/ Scope of the training session Ms. Redmond will teach participants of this webinar the ways by which their organizations can put a CSIRP in place. She will help them establish Key Performance Indicators (KPI) to determine if their CSIRP meets business objectives and operational metrics for effecting process improvement. She will also show participating organizations the ways of tailoring and enhancing their existing CSIRP and requirements for specific audiences based on the sensitivity of the information for which they are granted based on policies. Other important learning outcomes offered at this session include how to strengthen IT Risk Management, which involves integrating information security risk management with Enterprise Risk Management and requires using common business terminology, congruent methods, and common or linked risk register, and establishing mechanisms for risk acceptance. Ms. Redmond will also explain to participants how they can build an IS regulation review process, schedule regulation requirements and put in place a set of procedures that help to deal with a breach, malware and related issues.

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

Camping Success


A fun destination blog which discusses all things camping from camping success tips, to camping destinations to best camping gear!

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.

New Way of Exploring Economic Environment


Lineament analysis in geological exploration The existence of efficient and cost-effective methods that help to identify prospective targets that are related to or are influenced by tectonic structures is not common knowledge among professionals in the field of geological exploration. The right sampling and Quality Assurance/Quality Control (QA/QC) procedures are essential in all aspects of the mineral deposit evaluation process to achieve the best possible confidence in resultant mineral resource and reserve estimates. Getting Quality Assurance and Quality Control procedures and protocols right is crucial Accurate and proper QA and QC procedures and protocols are essential to ensure that data collected and created by the mining organization is of a high level of quality and is in compliance with CIM Standards and Guidelines. Geological quality control procedures are meant to monitor precision and accuracy of the assay data, as well as possible sample contamination during sample preparation and assaying. The quality of the data used determines the quality of an estimate. To offer a complete understanding of this concept, GlobalCompliancePanel, a reputable provider of professional trainings for all areas of regulatory compliance, will be organizing a two-day, live seminar. Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900719SEMINAR?new-economic-environment-Boston-MA. The Director of this seminar, Ricardo Valls, will introduce to the participants a methodology that will help them to concentrate their exploration efforts even over new areas with limited or nonexistent geological information, while keeping their budget in check. The centrality of QA&QC procedures Ricardo will explain how lineament and satellite interpretation are a way to define where to concentrate exploration efforts, as well as how to implement QA&QC procedures to guarantee the quality of the collected data. This is necessary, considering that compliance with the industry-established QA/QC is no longer an option, but a necessity for all the companies to implement, especially those that trade in the markets. Quality assurance is essentially the management system that operates to ensure credible results. The prime objective of the field QA program is to maximize accuracy by reducing introduced variability. The learning will be gleaned from a quality assurance program that the Director has implemented for the field sampling procedures. This includes collection, labeling, and shipping components. The quality control component of this system is a set of activities intended to control the quality of the data from collection through to analysis. It consists of day-to-day activities such as: o The adherence to written protocols; up-to-date and suitable training of personnel o The use of reliable laboratories with excellent QA&QC systems in place o The regular use of quality control (QC) samples (blanks, standard samples, and field duplicates) o Diligent record keeping. Ricardo will cover the following areas at this seminar: o History of the problem, why we need to change the current approach o Lineament analysis o Lineament analysis and satellite interpretation of data o Physical modeling (3D strain analysis and 3D stress analysis) o Statistical procedures (Compositional data analysis, correlation analysis, principal component and other methods) o Defining a QA/QC program, Blanks, duplicates, standards, external controls o Procedures and audits o Rock naming in the field o Conclusions and recommendations.

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.

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Emerging Issues in Food Safety-Globally


The Global Food Safety Initiative is a private enterprise by those in the food industry aimed at offering guidance to the food industry for making food chain safer. This industry-driven initiative seeks to provide thought leadership on the various aspects of food and guides the food industry on implementing safety standards along all the points in the food chain. Origins of the Global Food Safety Initiative: The Global Food Safety Initiative was conceived and finessed in the 1990’s and 2000’s in the backdrop of various international food-related crises such as the mad cow disease in the UK, the dioxin affair in Belgium and the 2008 listeriosis outbreak caused by the Canadian company Maple Leaf. These crises triggered a strong desire for collective action by the food industry for taking creative preventive steps that could stall the occurrence of such events in the future. These crises provided the reason for the birth of the Global Food Safety Initiative. The Global Food Safety Initiative was born out of the realization by leaders in the food supply and retail industries of the lack of coordinated audit procedures in the industry. Whatever audit and other checks and balances methods existed till then were largely fragmented, which is why they believed these crises happened. One of the primary aims of the Global Food Safety Initiative was to coalesce these procedures and set standards for their implementation. The Global Food Safety Initiative, which was created out of collaborative actions from an independent network, the Consumer Goods Forum (CGF), which consisted of CEO’s from the leading players of the food retail industry, has a vision of making safe food available to consumers, no matter where they are located. Objectives of the Global Food Safety Initiative: The core objectives of the Global Food Safety Initiative are: The workings of the Global Food Safety Initiative: The Global Food Safety Initiative carries out its aims and objectives by holding meetings, conferences and seminars and other such events at local and regional levels. The aim of the Global Food Safety Initiative is to use these events as the platform for sharing knowledge of how to go about their work. The Directors of the Global Food Safety Initiative are chosen from among the leaders of the industry. The CGF drives the day-to-day functions and administration of the Global Food Safety Initiative. Certification from The Global Food Safety Initiative: Depending on the stream of retail business a company is in, The Global Food Safety Initiative issues certificates to entities that satisfy its conditions on meeting safety standards. To get certified from the Global Food Safety Initiative, companies in the food retail industry need to meet required standards by having the necessary audits carried out for their systems. Once a Global Food Safety Initiative certificate is issued, the organization has to ensure its upkeep by carrying out regular subsequent actions as required.



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Tangy tales


Cooking is devotion - this is my mantra! I am a pharmacist by profession and live in Margoa, Goa. Am also, a tireless vegetarian food and travel lover. I believe in making traditional dishes and preserving the recipes. Through my blog: www.tangytales.com, I endeavor to share healthy vegetarian recipes with you. I salute to all the devoted mothers and fathers (which may be rare….), grandmothers, and all the wonderful women, who have dedicated their immense time towards cooking, for years at a stretch….to ensure their kids and their loved ones, eat tasty and healthy food ! We all love to eat good tasty food, but it isn’t imperative that all of us love to cook too. This is because each one of us is not aware of the joy of cooking! I truly believe anybody can cook!