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Course "New HIPAA Audit and Enforcement Activities: Being Prepared to Show your Compliance " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: We will be discussing the history and evolution of HIPAA Privacy/Security and the major points you need to understand to proactively protect your practice or business from the imminent federal auditing process: * History of HIPAA * HITECH * HIPAA Omnibus Rule * How to perform a HIPAA Security Risk Assessment * What is involved in a Federal audit and how is it conducted * Risk factors for a federal audit * How to avoid a Federal audit * Business Associates and HIPAA audits * EHR and HIPAA * Business Continuity/Disaster Recovery Planning * Assessing your contractors and sub-contractors * In depth discussions on IT down to the nuts and bolts * Risk factors that can cause an audit (low hanging fruit) * New rules which grant states ability to sue citing HIPAA on behalf of a patient * New funding measures Why should you attend : The evolutions of this enigmatic law and how what was once relative benign in terms of enforcement is now fully funded and aggressive. Learn what you can do to be prepared for an audit and how to lower risks of ever being audited. It is absolutely imperative that you are proactive and not reactive with your compliance program, this is a necessary evil and you need to protect your practice or your business and limit risks from the imminent Federal audits. Join me in keeping up with this very confusing law and take advantage of all the templates and information provided as part of the seminar. Areas Covered in the Session: * HIPAA -Brief History * HIPAA Privacy Rule vs HIPAA Security Rule * HITECH Act * Breach Notification Rule * Omnibus Rule and audits * Business Associates and audits * Current Court Cases (precedence) * Paper Based PHI Concerns and how to lower risk

The Clinical Laboratory Improvement Amendments of 1988 All clinical laboratory testing done on humans in the US, save those done for basic research and clinical trials, have to comply with the provisions of the Clinical Laboratory Improvement Amendments (CLIA). Clinical Laboratory Improvement Amendments, a set of federal amendments carried out in 1988 set out federal standards for carrying out clinical laboratory testing. A clinical laboratory is, according to the CLIA, a facility in which laboratory testing is done on samples procured from humans. This testing is done with the aim of obtaining information with the intention of evaluating health, using which clinicians diagnose, prevent, or treat disease. Having defined a clinical laboratory thus, the Clinical Laboratory Improvement Amendments set out the regulatory guidelines on which clinical trials are to be administered. The fundamental aim of the Clinical Laboratory Improvement Amendments is to ensure accuracy, efficacy, safety, reliability and efficiency of clinical trials. The Clinical Laboratory Improvement Amendments seek to do this by setting aside grades for a range of criteria that relate to these aspects of the clinical trial. These grades are given from a score of 1, meaning the lowest, to 3, the highest, to assess as many as seven criteria of a particular clinical trial. These seven criteria are: Knowledge Materials used in proficiency, quality control, and calibration of materials Features of operational steps Experience and training Troubleshooting of test system troubleshooting and maintenance of equipment Preparation of reagents and other materials Interpreting and judging the results of the tests Points to be borne in mind for enforcing provisions of the Clinical Laboratory Improvement Amendments Provisions set out in the Clinical Laboratory Improvement Amendments are to be enforced through a set of parameters. These include: Procedure manual A basic part of the Clinical Lab

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

Overview: This presentation will introduce the participants to changing role of the panoramic x-ray machine in dental offices today. Its expanding role in extra oral exposures and enhanced diagnostic capabilities is forever changing the path of dental x-ray imaging. Digital radiography is rapidly improving in diagnostic quality and loweringthe radiation exposure with ultra-low dose technology. We can have extra oral 2D bite wings and periapical x-rays with less radiation and greater diagnostic capability than traditional intraoral x-rays. The time has come that all dentists should have access to 3D-Cone Beam Computer Tomography. It is rapidly becoming the standard of care. Why should you Attend: Digital radiography is rapidly changing in today's dental offices. The new technology is revolutionizing patient flow and improving diagnosis. Dr. Jesek is at the forefront of this technology, using both 2D and 3D radiography. Seminar attendees will get easy to understand approach, which enables deep learning and provides tools they can use when they get back to the office Monday morning. Areas Covered in the Session: CBCT can be used to in areas of general dentistry to improve patient acceptance and quality of treatment outcomes. General and Restorative Dentistry Oral Surgery Implant Dentistry Endodontics Periodontics Orthodontics Sleep Apnea/Air way Who Will Benefit: Dentists Hygienists Assistants Speaker Profile : Dr. Warren Jesek graduated from Millikin University with a B.A. in biology and chemistry. After, he completed graduate work studies in anatomy at the University of Nebraska before attending Loyola University Dental School where he received his dental degree in 1979. He has maintained a private general practice in Decatur, Illinois since 1979. Unique to the area, his practice houses a crown and bridge laboratory with three technicians focusing on CAD/CAM milling technology to produce metal-free inlays, crowns and bridges. Dr. Jesek continued his training

Overview: Participants will understand the importance of responding to the OCR pre-audit requests and how to respond. Our discussion will cover how to prepare for an anticipated OCR HIPAA privacy audit, by discussing how to conduct an internal self-assessment of your privacy program. We will discuss how to conduct the self-assessment, whether it be the need for policies, procedures or obtaining all of your business associates information. Why should you Attend: If you have received a request from the OCR to provide the name of your entities privacy official and additional criteria, you are already aware that you are on the OCR's radar and may be the focus of an audit. If you haven't received a request yet, anticipate receiving one soon. In addition to ensuring that your HIPAA program is audit ready, you also need to ensure that you know all of your business associates and have their information readily available to provide to the OCR. Your entity needs to be ready now, as the OCR will either conduct focused desk audits, on-site audits or both in effort to review documentation of evidence of your compliance with the HIPAA regulation. Areas Covered in the Session: Office of Civil Rights "OCR" requests for privacy official and additional information and timeline for response Internal assessment criteria of privacy program in anticipation of an OCR audit Conducting the assessment using the template based upon HIPAA regulations Discuss methods to address any found deficiencies Workforce training Who Will Benefit: Healthcare providers Compliance and Internal Audit professionals or office staff responsible for ensuring patient privacy Healthcare Administrators Business Associates and all HIPAA Covered Entities Speaker Profile Gail Madison Brown is a registered nurse and an attorney with over 25 years of experience in health care. For the last 15 years she has focused on health care compliance and revenue cycle management operations. Gail's experience ranges

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 course. Why should you 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 taken to mitigate risk. 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? 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 "Required" and "Addressable" Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Assessment? What are HIPAA training requirements? What is a HIPAA data breach and what happens if it occurs? What are the penalties and fines for non-compliance and how to avoid them? Creating a Culture of Compliance Questions Who Will Benefit: Com

Overview: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices. Why should you attend: Information on drugs and devices is plentiful. But, it can also be daunting .The webinar will give attendees a foundation and a starting point on which they can build. Learning objectives: Define drug research Define device research Explore the differences between the two Describe requirements when drugs and devices are combined in one study Areas Covered in the Session: Defining Drug Research FDA approved drugs Investigational drugs Compassionate use Defining Device Research FDA approved devices 510 K devices Humanitarian Device Exemptions Invitro Diagnostic Devices Investigational Devices Federal regulations governing drugs and devices Guidance governing drugs and devices Combining devices and drugs into one study What are the requirements? What are the regulations and guidance? How these studies are reviewed Who Will Benefit: Investigators Researchers Research Staff Study Coordinators Auditors Research Administrators Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with st

Overview: The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be present before, during and after the trial. These documents help provide quality assurance and help researchers evaluate their compliance with GCP, federal regulations and applicable laws. Why should you Attend: Anyone responsible for handling trial documentation or quality assurance activities. Areas Covered in the Session: Trial Master File (TMF): what is it? Essential documents required ICH guidelines and Good Clinical Practice (GCP) Food and Drug Administration (FDA) guidance and expectations Paper or electronic trial master files - what is allowable Links to useful resources Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research New Clinical Research Coordinator positions (1-2 years) New Principal Investigator positions Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research manageme

Overview: Participants will learn how to conduct an investigation of allegations of patient privacy violations using a privacy "risk analysis" tool and steps that should be taken when a breach has been determined. Why should you Attend: You must conduct a prompt and thorough investigation of all allegations of privacy violations. A violation of a patient's privacy may result in monetary penalties, harm to your reputation and especially harm to a patient. You need to make certain your organization has the expertise to conduct a thorough privacy investigation, analyze the results and take all necessary action to mitigate and report violations when required. Areas Covered in the Session: Best practices for conducting a privacy investigation Use of the risk analysis tool Interpretation of your results Reporting requirements if necessary Recommendations of continued privacy monitoring Workforce training Who Will Benefit: Healthcare providers Compliance and Internal Audit professionals or office staff responsible for ensuring patient privacy Healthcare Administrators Business Associates and all HIPAA Covered Entities Speaker Profile : Gail Madison Brown is a registered nurse and an attorney with over 25 years of experience in health care. For the last 15 years she has focused on health care compliance and revenue cycle management operations. Gail's experience ranges from starting new compliance programs and making improvements to existing programs for physician practices to large health care organizations. Gail also has provided numerous lectures to healthcare providers, executives and professional colleagues. Gail Madison Brown will develop, implement, and oversee processes, systems, educational programs, and other activities necessary to support and grow clinical trials activities at the UT Health Science Center. The Chief Clinical Trails Officer (CCTO) provides overall strategic leadership in this area including planning, goal setting, and monitoring organ

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

HIPAA Enforcement trends : Health Insurance Portability and Accountability Act (HIPAA) is a legislation of the American Congress. HIPAA enforcement consists of taking steps to confirm that rules set out in HIPAA are being complied with by the requisite entities. Primarily passed with the intention of ensuring that employees do not lose their health insurance benefits when they change or leave their current jobs; this 1996 law also has the protection and security of Protected Health Information (PHI) as one of its chief aims. The Office of Civil Rights (OCR), which enforces actions relating to HIPAA, imposes harsh penalties on healthcare organizations and Business Associates and Covered Entities that are proven to be in noncompliance of HIPAA requirements. What are HIPAA enforcement actions? The actions that the OCR takes to ensure implementation of HIPAA provisions constitute the essence of HIPAA enforcement actions. There are a good number of areas which the OCR can cite as constituting cases of HIPAA violations or noncompliance. A look at recent HIPAA enforcement actions point to a trend. These trends serve as an indicator of what to expect from HIPAA enforcement actions, which will help entities get some idea of what they should implement and what they should not and thus prevent being cited by the OCR. Security risk assessments are the foremost element of HIPAA enforcement actions: A look at recent trends suggests that HIPAA enforcement actions mainly target security risk assessments. This leads to harsh penalties, as happened in the case of New York-Presbyterian Hospital (NYP). The hefty $ 4.8 million penalty slapped in 2014 on this hospital was for data breach caused by insufficient security risk assessment. While this is the biggest sum fined; the OCR issued at least three other hospitals for putting in place inadequate security risk assessments in 2014. Risk management comes a close second: If inadequate security risk assessments come first in te

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

Overview: During the webinar Participants will be addresses on the key regulatory provisions for cosmetic products in the major global economies. The EU's new Cosmetic Product Regulation (EU CPR) will be given a certain, wider position as the EU CPR is representing the latest, most modern regulatory framework which is influencing other global legislators. For the regulations of the USA, Canada, China, Japan, South Korea, Taiwan, ASEAN, India, Brazil, Mercosul/Mercosur and Russia, a general introduction into the key provisions will be given. Some specific difficulties arising from the existing discrepancies in the global frameworks will be depicted. Areas Covered in the Session: The new EU Cosmetics Regulation Basis principles and provisions Experiences and obstacles from the implementation phase Options for compliance approaches and available supporting tools Remaining issues and future perspectives and activities Cosmetics Regulations in Asia China & Hong Kong South Korea Japan Taiwan The ASEAN Cosmetics Directive India Russia Cosmetics Regulation in the Americas - Existing Global Discrepancies and International Harmonization Attempts USA Canada Mercosur / Mercosul South Africa Existing Global Discrepancies Harmonization Attempts The Intern. Cooperation on Cosmetic Regulation (ICCR) Who Will Benefit: Business Owners Managers in manufacturing New staff in manufacturing QA Administrative Managers Regulatory Compliance Associates Customer Service Speaker Profile Dr. Annelie Struessmann is Technical Director with CONUSBAT, a provider of internationalization services for the Fine Chemicals, Cosmetics & Life Sciences Industries: www.conusbat.com. She joined the firm in 2003 and established the service area of regulatory affairs where she is focusing on the European regulatory frameworks for cosmetic products and for chemicals (REACH). The service spectrum includes dossier preparation, safety assessments, registrations, notifications and direct representations, etc. S

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

Overview: Mental health care practitioners work in today's diverse, fast-changing, multidisciplinary health care environment. Nowhere but in mental health is there such diversity of clinicians who provide the same or similar services of counseling and therapy. Yet each individual mental health profession has a unique education, training, and experience requirement for practice. The state's authority and power over mental health practitioners often presents challenges to mental health professionals that are not easy to navigate. All mental health practitioners must adhere to standards of state law which govern their professional practices, including the doctor-patient relationship. Codes of ethics and state law may both apply to govern the conduct of this clinician. Complaints that are received and investigated by a state agency leave the mental health practitioner with an uncertain process to handle the state action against them. Learn to identify and understand an ethical framework for a sound mental health practice. Describe the inherent risks in mental health practice. Review the three most common violations of law against mental health clinicians. Compare and contrast regulatory laws and codes of ethics. Learn practical tips about how to avoid liability and manage risk in clinical settings. This allows the mental health care practitioner to avoid sanctions and to defend against legal actions which may result in ruinous practice and career consequences for the mental health practitioner. This program offers an objective, thorough review of ethics and law for mental health practitioners. Price : $139.00 Contact Info: MentorHealth Phone No: 1-800-385-1607 FaX: 302-288-6884 support@mentorhealth.com Event Link: http://bit.ly/Ethics-and-Law-for-MentalHealth-Professionals http://www.mentorhealth.com/ LinkedIn Follow us - https://www.linkedin.com/company/mentorhealth Twitter Follow us - https://twitter.com/MentorHealth1 Facebook Like us- https://

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

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

Course "Fundamentals of Statistical Process Control: Implementation and Assurance of SPC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-day seminar provides the information you need to use one of the most powerful tools in quality, statistical process control. It will help people in design, quality, and production understand the concepts and effectively implement them. The examples and issues in the seminar come primarily from the medical device industry, but the material is applicable to any production environment. Production process must be controlled to help ensure they are stable. While there are many control methods, the most powerful and often used is statistical process control, SPC. It uses data from the process itself to detect changes - changes that could result from an unstable process. SPC helps determine if a process continues to operate the way it was set up. If not, SPC produces a signal that calls attention to the problem. One very important application is process capability analysis. With a stable process, SPC data can help determine if the process is capable of meeting the product specifications. These are often expressed as process capability indices. Continuous improvement programs can use the information generated by SPC to monitor process variation and identify its causes. These methods can reduce cost, improve product, and enhance customer satisfaction. Why should you attend: Manufacturing companies, especially medical device manufacturers, must control process. Not only is this a regulatory requirement, but is a good business practice. Without a solid understanding of SPC, you put yourself and your company at a disadvantage. On a personal basis, the material in this seminar will help improve your skills; it aligns with the ASQ Body of Knowledge for the Certified Quality Engineer, Green Belt, and Black Belt. These are areas you should master

Elliott Connie is a solution focused brief therapy trainer, author and psychotherapist. While most training materials and books about the Solution Focused Approach focus on what it is, Elliott offers products and events that focus more on the "how to" side of Solution Focused Therapy. The goal of these materials and trainings is always to increase the skills and abilities of those using them, allowing immediate use in work with clients

J6 Power Wheelchair The compact J6 is the ultimate choice for users who demand the superb stability of Mid-Wheel 6 design and tight-quarter maneuverability. Highly adaptable, the J6 accepts a wide range of seating and electronics options while its powerful drive train delivers high-performance torque. J6 Power Wheelchair Features: Mid-Wheel 6 allows six wheels on the ground for maximum stability. Compatible with TRU-Balance Tilt. OMNI-Casters (nylon, spherical-shaped casters) on front and rear prevent wheel hang-ups. Side-mounted, easily accessible freewheel levers. ATX Suspension (Active-Trac with extra stability) incorporates front OMNI-Casters for enhanced. Performance over more varied terrain. Easy front access to batteries. J6 Power Wheelchair Specifications: Drive Wheels: 10" Solid Optional: 10" Pneumatic Caster Wheels Front: 5" Solid Rear: 6" Solid Anti-Tip Wheels N/A Maximum Speed^4/^: Up to 4 mph Ground Clearance: 2.5" (frame) Turning Radius^5/^: 22" Overall Length: 34.74" without foot riggings Base Width: 23.19" Seating Sizes: TRU-Balance® 2 Synergy/Static: W: 10-20" D: 10-20" Power Tilt: W: 14-20" D: 14-20" Lift & Tilt: N/A Seat-to-Floor Heights: TRU-Balance® 2 Synergy/Static8: 16.5" - 17.5" Power Tilt8: 16.875" Lift & Tilt8: N/A Manual Tilt/Recline^10/^: Yes Battery Size^6/^: U-1 Battery Weight^14/^: 23.4 lbs. Available Electronics^12/^: 70A Q-Logic 2 NE 70A Q-Logic 2 NE+ 70A Q-Logic 2 EX Battery Charger 5A Off-board Motor Packages 2-Pole 4 mph Weight Capacity^7/^: 300 lbs.9 Base Weight: 100.2 lbs