Group items tagged

Overview: One of the major requirements of the health care organization to be HIPAA compliant is to develop and implement a set of HIPAA privacy and security policies and procedures. This can be a daunting task for those not knowing where to start and what a set of HIPAA privacy and security policies and procedures should look like. For the cost conscious health care organization, the HIPAA policies and procedures can have multiple uses: first, they can become a basis for training the health care organization workforce; second, they can be used as a basis for conducting a HIPAA self-assessment; and third, they can be used to demonstrate due diligence should there be a breach or an externalHIPAA compliance audit. In today's world it is not necessary that the health care organization spend significant funds to develop a set of HIPAA privacy and security policies and procedures from scratch. The health care organization can likely find templates on the internet that can be used as a starting point to customize HIPAA policies and procedures to be unique for the health care organization. The preparation of a well-documented set of HIPAA policies and procedures needs to be addressed through the development of Privacy and Security policies and procedures that address each of the requirements shown in the HIPAA regulations as amended by the HITECH law and the final Omnibus Regulations. The process of developing the HIPAA privacy and security policies and procedures also provides a reference for the health care organization how to consider the security addressable and required regulation requirements. Why should you attend: There are three situations where having a set of HIPAA policies and procedures are needed: First, the policies and procedures become a good reference to ensure that all areas are addressed for becoming HIPAA compliant. Second, the HIPAA regulations REQUIRE covered entities and business associates to have a set of policies and procedures directing

Overview: I will be talking to specifics of HIPAA in the hospital setting, , do's and don'ts as well as dispelling myth vs reality. This lesson will be addressing how compliance officers need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016 and beyond. There are an enormous amount of issues and risks for hospitals these days especially with the new legislation involving patient cash remedies for wrongful disclosure. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on HIPAA cases within the hospital setting, ER setting, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices. Why should you Attend: What can and can't we do in the hospital setting with patient information? What are the new liabilities involved? How can we ensure security but also ensure patient care? This once rarely enforced law has changed and you need to know what's going on! - there are new liabilities! What factors might spurn a HIPAA audit? …are you doing these things? Why are the Feds strictly enforcing after all these years? State laws are now much tougher increasing liability for patient remedies! We will be discussing some of the changes taking place in Washington with the Health and Human Services in regards to the enforcement of the HIPAA laws already on the books. I will go over some of the new changes specifically affecting the hospital as well as the emergency room setting I will also be discussing factors might cause an unwanted visit or letter from the Office of Civil Rights and how to prepare for a potential audit Areas Covered in the Sessi

Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta

A look at disruptive practitioner behavior policies: One of the very important factors needed for a healthcare unit to maintain its decorum and uphold its reputation is the implementation of disruptive practitioner behavior policies. The declaration and implementation of disruptive practitioner behavior policies goes a long way in ensuring that the hospital or healthcare center doesn't lose face. What are disruptive practitioner behavior policies? First, an understanding of disruptive practitioner behavior policies: Disruptive practitioner behavior policies may be termed as the putting in place in a healthcare providing unit a set of policies that are aimed at checking the errant and rude behavior of its staff members towards the patients and other people that use the services rendered by these centers. Who all carry out disruptive practitioner behaviors? Anyone in the healthcare setting can behave in an unbecoming and ungainly fashion with patients or those attending on them. Some of the typical types associated with disruptive practitioner behavior include shouting at them, bullying, intimidating, scolding loudly, being aggressive towards them, gesturing lewdly to them, and so on. This kind of behavior reflects very badly on the healthcare provider. Since there is intense competition in the healthcare providing industry; it is natural for patients to look for other centers when they face this kind of behavior. It is after all human to expect to be treated nicely. If one provider doesn't do that; patients look for other providers. Losing the patient, bad though it is, is not the only loss: When this becomes public, which is all the easier given the extensive reach of the social media; the healthcare unit's name goes for a toss. The role of disruptive practitioner behavior policies It is to curb this kind of behavior that disruptive practitioner behavior policies need to be put in place. Disruptive practitioner behavior policies can go a long way in reining i

Course "HIPAA - Putting an Organizational Compliance Program in Place" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive 2 day training course. Why you should attend With an increase in HIPAA enforcement and Phase 2 audits underway, many organizations need to fully understand the requirements of a compliance program. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to be taken to mitigate risk. The seminar will include practical exercise to assist in knowing how to develop, review, and amend HIPAA policy and procedure. After completing this course, a Covered Entity or Business Associate will have a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session * Why was HIPAA created? * What is HITECH and the Omnibus Rule? * Who Must Comply with HIPAA Requirements? * What are the HIPAA Security and Privacy Rules? * What is a HIPAA Compliance Program? * What is a HIPAA Risk Management Plan? * What is meant by

Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove

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: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the understanding the fundamentals of a HIPAA and how you will be required to demonstrate your organization's compliance program. If your healthcare practice, business, or organization needs to understand how to be prepared for an increase in HIPAA enforcement and make sure your current safeguards are adequate and can withstand government scrutiny, please join us for this informative and interactive course. Why should you Attend: BAll most 120,000,000 individuals were affected by HIPAA data breaches in 2015. This is a significant reason why Congress has inquired about the recent and very sizeable increases in cyber-attacks that inflect the risk of medical identity theft. The HHS Office for Civil Rights not only are conducting audits but is looking to increase HIPAA enforcement. Attendees will leave the course clearly understanding of all the requirements that must be in place for HIPAA and how to demonstrate compliance if audited. After completing this course, a Covered Entity or Business Associate will be able to know what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: Why was HIPAA created? What are the HIPAA Security and Privacy Rules? What is a HIPAA Risk Management Plan? What is meant by "Required" and "Addressable" Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Assessment? What are HIPAA training requirement

Overview: This webinar provides an overview of the MACRA legislation and developing regulations and guidelines. We'll help you understand how medical practices will be paid in the future for services to Medicare patients. You'll be asked to choose between two paths. If you choose to participate with other providers in an Advanced Payment Model, the larger organization will be paid for services provided and determine how to share those payments as well as any cost savings among the participants. If you choose the Merit-Based Incentive Payment System (MIPS), your payment rate will vary based on how you perform on a variety of Medicare Quality Programs - PQRS, VBM, Meaningful Use and a 4th new component focused on Quality Improvement. You'll want to know as much as possible about the pros and cons of each option and how to make the right choice for your practice. Why should you Attend: Under the MACRA legislation, your providers will need to choose between participating in an Advanced Payment Model (APM) or participating in the new Merit-Based Incentive Payment System. Making the wrong choice can result in significant reductions in your future Medicare payments. You'll want to understand the options and have a plan in place by January 1, 2017 - that's only 6 months away. Areas Covered in the Session: Learn the requirements of the new MACRA legislation and how it will impact your Medicare payments in 2019 and beyond Find out what you need to be doing now to ensure you don't lose Medicare revenue in future years Understand the options - APM vs MIPS - and how your Medicare payments can increase or decrease under each model Identify what aspects of the new payment methodology are written into the legislation, what has been released through proposed regulations and when final rules are expected. Who Will Benefit: Practice Administrators, CEOs, COOs Physicians and all providers who bill to Medicare Quality Officers Nurse leaders Finance Directors Speaker Pro

Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your organization needs to understand the role of the HIPAA Security Official, the requirements, and make sure the current compliance program is adequate and can withstand government scrutiny, please join us for this informative and interactive course. Why should you Attend: The role of the HIPAA Security Official is critically important in complying with the HIPAA Security Rule. Besides being responsible for many of the daily operations within an organization, the Security Official is tasked with managing the HIPAA compliance program. Knowing what is required is part of the Security Official's duties. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and to make sure on organization has the proper policies and procedures in place. After completing this course, a HIPAA Security Official will have a clear understanding for 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? The Role of the HIPAA Security Official What is a HIPAA Compliance Program? What is a HIPAA Risk Management Plan? What is meant by "Required" and "Addressable" Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Asses

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

Overview: This lesson will be going into great detail regarding your practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why should you Attend: HIPAA NOW HAS TEETH! Be prepared for what's new in 2016! Protect your practice or business! What factors might spurn a HIPAA audit? …are you doing these things? Why are the Feds enforcing after all these years? It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence to minimize risk. Areas Covered in the Session: Updates for 2016 BYOD Portable devices B

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 "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

A Hospital Incident Command System is a wonderfully effective system for handing disasters and emergency situations: A Hospital Incident Command System is an absolute must for hospitals when they have to carry out unforeseen emergencies. Having a process-oriented Hospital Incident Command System is an effective tool for dealing with situations and saving lives. A Hospital Incident Command System (HICS) is a standardized process that helps hospitals deal with emergencies, natural or manmade. HICS is common across hospitals in the US and have common terminology and organizational structure. It is a single system that all hospitals have to use. Since emergencies can happen at any time and can be of any gravity; it is imperative for physicians to have a command of how to deal with emergencies by understanding the Hospital Incident Command System and its role in disaster situations. HICS goes beyond patient care. Physicians and other staff need to both have access to disaster-specific and related information to the Hospital Incident Command System, as well as know how to handle it, in order to bring about an effective response and augment an existing one. Advantage of having a Hospital Incident Command System The biggest advantage of having a Hospital Incident Command System is that its practices and processes are similar to those used by external agencies in times of emergency. This makes sharing incident command systems that much more effective and easier to coordinate, and facilitates information flow. Features of a Hospital Incident Command System A Hospital Incident Command System provides a flexible reporting structure with defined roles and responsibilities It sets up and facilitates communication flow and documentation protocol It provides the hospital operations a concrete strategic direction-oriented support by leveraging and optimizing additional resources such as staff and equipment, so that these are used where they are needed the most. A Hospital Incident

Dealing with Medicare and Medicaid Overpayments : Medicare and Medicaid overpayments are pretty common. If they are not dealt with properly, they invite penalties. Medicare and Medicaid Overpayments happen when a person, provider or supplier receives a payment that is in excess of the amount due to him or her under Medicare statutes and regulations. This overpayment becomes a federal debt that is owed by the individual to the State. So, Centers for Medicare and Medicaid Services (CMS) is required by federal law to recover this amount. Overpayments routinely occur in Medicare and Medicaid. Many a time, these are unintended and are usually a result of oversight, but could also happen due to intent. Some of the most common reasons for which Medicare and Medicaid overpayments occur can be when: Duplicate submissions of the same service or claim are made Excessive or non-covered services are billed or furnished for billing Services that are not necessary medically or are excluded are paid for The wrong payee gets paid. How are Medicare and Medicaid overpayments processed? Obamacare has amended the federal False Claims Act (FCA), which is part of the Fraud Enforcement Recovery Act of 2009 (FERA), to add provisions relating to recovery of Medicare and Medicaid overpayments. This is how the process of Medicare and Medicaid overpayments works: Whenever Medicare comes to know that any overpayment of $10 (raised to $25 from July 2014) or more is made, it directs the Medicare Administrative Contractor (MAC) to initiate the process of recovery of this overpayment. The MAC starts the process by initially mailing a demand letter in which repayment is requested If no action is taken, a second and third demand letters are mailed in a month following the first one. Contents of a demand mail from Medicare/Medicaid: The demand letter sent by the MAC will explain the details of the Medicare and/or overpayment. When repayment is not made in full within 30 days, interest starts get

Course "HIPAA - Putting an Organizational Compliance Program in Place" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive 2 day training course. Why you should attend: With an increase in HIPAA enforcement and Phase 2 audits underway, many organizations need to fully understand the requirements of a compliance program. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to be taken to mitigate risk. The seminar will include practical exercise to assist in knowing how to develop, review, and amend HIPAA policy and procedure. After completing this course, a Covered Entity or Business Associate will have a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: · Why was HIPAA created? · What is HITECH and the Omnibus Rule? · Who Must Comply with HIPAA Requirements? · What are the HIPAA Security and Privacy Rules? · What i

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

The entire course of treatment took 10 months to finish. It took another 2 to 3 months for him to recoup from symptom of chemotherapy. He was great when we had another set back in the time of June 2008 in the wake of knowing another tumor developing in Left Lobe of Liver. At that point we began attempting flighty treatment strategies, for example, Ayurveda, Touch treatment, A Medicine Claiming to Cure Cancer, Rituals Believes and Faiths, Cyclotron Treatment, Medicine of D.S. Inquire about Center Banaras and Wave Therapy. Just few of previously mentioned truly helped us to some degree yet none of them truly worked 100% according to their claim. I will go to every treatment techniques independently and give a reasonable assessment in view of my experience. I trust that may help individuals to take educated choice. Also, they can keep away from missteps which we did either because of absence of data or false trust.

From comprehension medicinal language to encountering "scanxiety," entering a growth place surprisingly can overpower. For youthful grown-ups beginning to set up their autonomy, the experience can be particularly scary. Having a care group you know and trust, and looking for psychosocial bolster through advising or care groups, can help numerous patients modify amid this troublesome time.