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Overview: Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: * Understand US FDA final rules for the Preventive Controls for Human and Animal Foods * Define and review your current system to identify gaps in your preventive controls planning. * Be able to develop and implement a valid preventive control company food safety plan to close any gaps * Write and implement appropriate procedures. * Know your requirements for control over your supply chain * Be able to plan and implement HARPC * Be able to perform environmental monitoring * Know how cross contamination can impact your preventive control plan * Know the difference between validation and verification * Understand and be able to use statistical process controls basics * Be able to plan and implement a team approach to preventive controls * Be able to help your food importers to jump through FDA hoops * Develop a system to risk rank your suppliers * Have a plan in hand that will pass any validation check for preventive controls * Understand some of the technology and costs that can help you establish preventive controls * Prove that your system actually prevents food safety problems * Be able to document and report results to upper management, external food safety auditors and FDA auditors * Save your company money Establish simple, low cost complete data collection and reporting systems. * Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system * Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures * Learn how to use your system to get some ROI and improve your marketing position * Review current and future technologies designed to improve and simplify data collection * Establish a completely documented system Why should you attend: Validation of preventive co

Overview: The presentation takes the participant through the steps needed to ensure a successful health care computer system implementation. Once presented the participant will see the logic of the tools and processes and be able to apply them to their system implementation. The tools and processes presented in this material have been developed by implementing health care systems for over 40 years and seeing what has worked and WHY it has worked. These tools and processes have been equally and successfully applied to the implementation of large, complex systems and smaller, simpler systems for large, multidepartment organizations and for small health care organizations. The process focuses on establishing the project's implementation expectations, identifying meaningful metrics for success, establishing project plans, assigning individual accountabilities and responsibilities, establishing and executing project tasks, monitoring project progress and validating project success. To establish viable project expectations, the presentation addresses the need for bringing all of the stakeholders (organization owners, providers and management, operations staff, IT staff and the vendor) into establishing common and realizable expectations. These are reviewed in context of the organization's current environment and its short and long term goals and are considered as a critical part of the implementation completion process. In the case of turning around an already troubled or failed system implementation, the process emphasizes the tasks of reassessing the project stakeholder expectations - why they decided the system would help the organization and what they expected to get from the system. Next the process shows the participant how to convert these expectations to realistic and measurable project success metrics. The process focuses on learning how to separate "so what" metrics from meaningful and measurable metrics. In addition, the process provides direction regardin

Which diet plan is suitable for me? Its not anymore unanswered. Keto diet is one of the popular diet plans these days. Diet plans for healthy weight loss

Health Insurance Market Reforms under Obamacare: The Patient Protection and Affordable Act (PPACA), or Obamacare, sets out a number of provisions for health insurance market reforms. Having been set in motion in March 2010; the PPACA sets out health insurance market reforms that are being implemented in stages from dates commencing generally from January 1, 2014. PPACA's health insurance market reforms are aimed at health insurance standards and group health plans. These reforms set out dates for the implementation of these reforms. They also prescribe penalties for noncompliance with these reforms. What kinds of market reforms are needed? The health insurance market reforms suggested by PPACA are almost singularly for group health plans. A group health plan is defined as one in which the employer makes a contribution into expenses accruing from the employee's health insurance plans. When an employer chooses to bring an employee's health plan under her coverage; the employer has to mandatorily comply with the provisions of the health insurance market reforms. Areas of the health insurance market reforms: These are the essential areas in which the health insurance market reforms are to be applied: Removal of lifetime and annual limits on essential health benefits: One of the primary provisions of the health insurance market reforms under PPACA is that it prohibits both lifetime and annual limits on essential health benefits, which were allowed some dollar limits prior to enactment of Obamacare. Preventive health services: An area of preventive health services that has undergone an amendment under the health insurance market reforms is that of no-cost sharing. Accordingly, employer plans are to offer preventive health services without requiring the employee to share the burden for this part of the plan. The three-month waiting period: The health insurance market reforms don't require a waiting period of over 90 days. A waiting period is the period that has

Overview: Remember spaghetti code? The HIPAA breach area is now almost as convoluted and overlapping and confusing as spaghetti code. Sometimes you think you are both coming and going at the same time when you think through an event to determine if your organization has had a breach. For example: Is a security incident always a beach? Is an ePHI breach a security incident as well? Is a cybersecurity event always a breach? What if it does not steal any clinical information, diagnoses or procedures information, or any payment information? A security incident? Or both? Are all the necessary kinds of notice in the Breach rule? What is Cybersecurity Insurance? Is it really the finger in the dike or itself full of Swiss cheese? Can the loss of patient or member data be a HIPAA breach and identity theft plus a fraud issue? Why should you Attend: HIPAA breaches now number in the multiple thousands, if not multiple millions. Your organization needs to be prepared for the initial sense of panic, a complete investigation, and the federal, state and reputational costs of a mega breach. A breach now costs in money approximately $225/record. And this does not include any fine of any type. The loss and theft of 1000 records may cost you organization from a quarter to $1 M, or more, and 6 months to a year to resolve. You need to know the basics of what PHI and ePHI really are; what puts the event into the breach safe harbor, what breach exceptions keeps the event out of OCR's hands, what the 4 factors are and how they are used. You need to know that your organization's breach plan and your policies and procedures include the need to notify when necessary the police, the FBI and other state and federal organizations beyond the Office for Civil Rights. Your organization needs to know how to protect itself after the fact by considering Cybersecurity Insurance. Areas Covered in the Session: Definition and reporting of a Security Incident Definition of a breach Breach Guidance Br

Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program offers an obje

2-day In-person Seminar Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing Overview: The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary, from a risk management perspective Agenda Day One Lecture 1: Regulatory Requirements Lecture 2: Vocabulary and Concepts Lecture 3: Confidence Intervals (attribute and variables data) Lecture 4: Normality Tests and Normality Transformations Lecture 5: Statistical Process Control (with focus on XbarR charts) Lecture 6: Confidence/Reliability calculations for Proportions Lecture 7: Confidence/Reliability calculations for Normally distributed data (K-tables) Lecture 8: Process Capability Indices calculations(Cp, Cpk, Pp, Ppk) Day Two Lecture 1: Confidence/Reliability calculations using Reliability Plotting (e.g., for non-normal data and/or censored studies) Lecture 2: Confidence/Reliability calculations for MTTF and MTBF (this typically applies only to electronic equipment) Lecture 3: Statistical Significance: t-Tests and related "power" estimations Lecture 4: Statistical Significance: ANOVA calculations Lecture 5: Metrology (Gage R&R, Correlation, Linearity, Bias , and Uncertainty Budgets) Lecture 6: QC Sampling Plans (C=0 and Z1.4 attribute AQL plans, and alternatives to such plans) Lecture 7: Statistically valid statements for use in reports Lecture 8: Summary and Impleme

Overview: In this session we will discuss the HIPAA audit and enforcement programs and how they work, and discuss the areas that caused the most issues in prior audits. We will explore what kind of issues and what kind of entities had the most problems, and show where entities need to improve their compliance the most. We will also explore the typical risk issues that lead to breaches of health information and see how those issues may be a target for auditors in the new 2016 audits. We will review the contents of the HIPAA Audit Protocol used in 2012 to show what documentation needs to be on hand should your organization be selected for an audit in the new round. We will present methods for using the contents of the HIPAA Audit Protocol to build your own compliance plan by extracting and updating the contents and relating your compliance activities directly to the questions that might be asked. In this session we will discuss the HIPAA audit and enforcement regulations and processes, and how they apply to HIPAA covered entities and business associates. We will explain the enforcement regulations and the new, increased fines and new penalty levels, including new penalties for willful neglect of compliance that begin at $10,000. We will discuss what information and documentation must be prepared in advance so that you can be ready for an audit at any time, including sample information request forms and questions asked at prior audits. The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your exposure. We will discuss how most enforcement actions come about and what can be done to prevent incidents that lead to enforcement activity. The HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited will be explained. Documentation requirements for compliance will be explored and a framework of security policies necessary

Some Habits That Ruin Your Weight Loss Plan. Although we may follow a strict diet plan and hit the gym.., sometimes it becomes nearly impossible to get rid of those extra pounds... The problem lies with the seemingly harmless everyday habits that we have nurtured over the years and...

While most of us are aware that eating cheesy sausages every day for breakfast is not really good for the waistline, there are many other subtle bad habits that keep on adding more pounds to our bodies. These habits are harmful because they have the potential to sabotage our weight loss plan.

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /

OSHA's Standards on Fire Protection in the Workplace : When it comes to Fire Protection in the Workplace; there are several guidelines to be followed. One could go by common sense, but it is not usually sufficient, which is why OSHA has standards relating to Fire Protection in the Workplace. Like it does for all its safety requirements; OSHA requires the employer to take obligatory steps for the protection of employees from fire. These are covered in Title 29 of the Code of Federal Regulations Part 1910 Subparts E and L; and Part 1926 Subparts C and F. Employer obligations are the core of Fire Protection in the Workplace Requiring employers to carry out roles during a fire emergency and training employees towards the same are the foundation of OSHA standards on Fire Protection in the Workplace. Training employees on OSHA's standards on Fire Protection in the Workplace entails training them on all the core areas of handling a fire: The ways of using fire exits The ways of using fire extinguishing equipment The ways by which to organize an emergency exit plan The ways of using fire exits: Fire Protection in the Workplace on fire exits involves having to put in place a well-designed exit route for employees, so that they escape during a fire easily. These should be done keeping in mind the structure of the building. Keeping the exit route free of obstacles is another important requirement of OSHA's standards on Fire Protection in the Workplace. The ways of using fire extinguishing equipment: Having portable fire extinguishing equipment is not mandatory for OSHA, but employees must be properly trained on their use, should an employer have one. These equipment have to be placed at a convenient location for everyone to access easily. The ways by which to organize an emergency exit plan: An emergency exit plan is required as part of Fire Protection in the Workplace for some kinds of employers. It is for those whose activity involves the heavy use of hazardous chemica

Overview: Learn how to improve your healthcare compliance program by using requirements found in corporate integrity agreements (CIAs) issued by the OIG. By proactively incorporating various features of CIAs, healthcare providers of all types can be better assured of meeting compliance standards. While there are many different types of healthcare compliance issues, probably the area of most concern is that of properly filing claims and receiving appropriate reimbursement. The OIG has issued various types of guidance including Federal Register entries, fraud alerts, and issues as listed in the OIG Work Plans. By providing such guidance, the OIG has given healthcare providers notice so that there can be no defense of not knowing about an issue. By organizing your compliance program to detect and then correcting various types of issues is a major objective of having a compliance program. Understanding systematic processes for improving your healthcare compliance program using CIA requirements can forestall possible criminal and civil monetary penalties. The hundreds of CIAs that have been developed when the OIG detects fraudulent activities can be used as a guide for developing and improving healthcare compliance programs for all types of healthcare providers. The process of statistical extrapolation is used by the OIG when conducting studies in order to determine recoupment amounts. Statistical extrapolation can also be used by healthcare providers when determining possible overpayments. However, the proper use of statistical extrapolation is a formal and complex mathematical process that must be properly applied. The OIG CIAs provide another resource for healthcare providers to study, understand, and then apply as appropriate. Why should you Attend: What are the OIG Corporate Integrity Agreements (CIAs)? Why does the OIG issue CIAs? Can I use general requirements from CIA to avoid monetary penalties or even avoid going to jail? Can any healthcare provider use

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

HIPAA Survival Guide: The HIPAA Survival Guide is a set of practical help guides that seek to make compliance with HIPAA and HITECH easy for providers. This kit is some kind of checklist on what to keep in mind and implement to survive a HIPAA audit. The HIPAA Survival Guide was created as a need to comply with the HIPAA audit requirements. It evolved as a response to simplifying the HIPAA Privacy Rule and HIPAA Security Rule without its legal complexity. In other words, the framers of this Guide have developed this concept strictly as a guide, rather than as a legally enforceable set of rules. "Forest from the trees" approach: The HIPAA Survival Guide came into being in order to help users understand HIPAA and HITECH better. The approach the developers of this Guide adapted was what was called the "forest from the trees" way, because the aim was to help users navigate and wade through the complex text. It was aimed at helping them chaff and finesse the parts that required their compliance into simple terms. HIPAA Survival Guide is thus not a strict, legislative Act that lays down rules for conformity. No wonder, it was developed by the joint efforts of a Registered Nurse and an Attorney, who wanted to facilitate a greater understanding of the legislation's audit requirements. The basis on which this Guide came into existence was the HIPAA and HITECH background. It concerns itself with only the part of HIPAA and HITECH relating to a part of Covered Entities, namely providers. This is deliberate, since the aim of this Guide is to help small providers with guidelines aimed at simplifying their task. Important steps for HIPAA survival: The fundamental goal of the HIPAA Survival Guide is to equip providers with the knowledge of what needs to be kept in order and fine-tuned if they have to meet regulatory requirements. These are the thumb rules for the HIPAA Survival Guide: Documenting the provider's privacy, security and breach policies and revie

Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance. The models also provide an understanding of the impact of variability in controllable and uncontrollable factors on important responses. The concepts behind DOE are covered along with some effective types of screening experiments. Case studies will also be presented to illustrate the use of the methods. This highly interactive course will allow participants the opportunity to practice applying DOE techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively in their process and product development efforts. Why should you attend: · Plan and conduct experiments in an effective and efficient manner · Apply good experimental practices when conducting studies · Determine statistical significance of main and interaction effects · Interpret significant main and interaction effects · Develop predictive models to explain and optimize process/product behavior · Check models for validity · Utilize models for one or more responses to find optimal solutions · Apply very efficient fractional factorial designs in screening experiments · Apply response surface designs for

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend: * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors / Senior

Overview: As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR). With certain exceptions, a person or entity that creates, receives, maintains, or transmits PHI for a function or activity regulated by the HIPAA Privacy Rule for a Covered Entity is a Business Associate. The HITECH Act, a recent update made to overall HIPAA regulations require Business Associates to comply with HIPAA mandates regarding the handling and use of health information. As a Business Associate you must comply with a wide-range of regulatory obligations, including certain privacy obligations, security standards, and breach notification requirements. If your business needs to understand what it means to be a Business Associate and know what required safeguards, policies and procedures must be in place or make sure your current compliance program is adequate and can withstand government scrutiny, please join us for this informative and interactive session. Why should you Attend: There is a lot of confusion about the role and requirements of being a Business Associate. Organizations must be prepared prior to entering into these contracts for services as a vendor and subcontractor. Attendees will leave the course clearly understanding of all the requirements that must be in place for the Business Associate - Covered Entity arrangement. After completing this course, a Business Associate will have a clear understanding as to what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: Why was HIPAA created? Who Must Comply with HIPAA Requirements? What are the HIPAA Security and Privacy Rules? What are the Consequences of being a Business Associate What is a HIPAA Compliance Program? What is a HIPAA Risk Mana

Tynor Exercising Ball Exercising ball is an excellent physiotherapy device to provide a pleasurable exercise plan for the hand, wrist, forearm and the fingers Safe and inert. High patient compliance. Excellent resilience for a long functional life . Compatible in thermal/hydrotherapy. Tynor Exercising Ball Features Ergonomic design and materials Two resistances available- Ortho (hard) & Neuro (soft) Compatible for thermal/hydrotherapy Flexible and pleasurable exercise schedules can be planned Better compliance Inert PU material, safe to use Excellent resilience, offers longer life. Tynor Exercising Ball Measurements Sizes Available: OR / NR

5 Things to Know about Medicare Drug Coverage Plans. CMS released rates for 2022 for Medicare Advantage Coverage plans. They released these rates prior to the period so that Medicare plans to review them for their final bids.