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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: 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 "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

Overview: Essentially, covering in 90 minutes the basics of E everything that applies to your clinical work. We will give you the questions to ask your IT people, because you should not implicitly trust them, because the law will hold you accountable more than them. We will first cover the general principles of electronic compliances as laid forth in HIPAA. We will then discuss how this applies to your desktop/laptop/iPads and smart devices, other electronic equipment such as routers and modems. We also cover the use of email, secure mail and your EHR/EMR. We will discuss the pros and cons of using the cloud for your data storage and EHR/EMR, i.e. knowing what a HIPAA compliant data center looks like. Principles in the use of encryption and passwords and other security principles will also be covered. Why should you Attend: Unless you are 100% sure you've thought through every angle of your patient's electronic PHI and you sleep like a baby never concerned about this then you need to attend. If you have any questions about the details of what electronic compliance looks like and how it's applied in day-to-day clinical and business activities, interactions with vendors, EHR/EMR, your relationship with your ISP and IT providers, use of all electronic devices, then this workshop is for you. It also gives you principles to apply in new situations which are likely to arise frequently. If you wrote the book on this it would be out of date in 24 hours, so what's important is to learn how to think about these things and use your resources to stay ahead of the game. If you are confident you have the basics covered on every item listed below then this seminar is not for you. Areas Covered in the Session: HIPAA electronic compliance Secure use of EHR/EMR Email and secure mail use Encryption and password security principles Interfacing with the public Interfacing with vendors such as ISPs and other telecommunication companies Backups Cloud use How to know your data center

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

Overview: This lesson is going to get back to the basics using multiple real life scenarios and "what if's". My goal is to make this very confusing and not well explained law easy to understand for the typical staff member. I will uncover myths versus reality as it relates to this enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also point out multiple court cases I have been affiliated with where a staff member of a hospital or clinic has been sued or even imprisoned! 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: Are you confused about HIPAA? Do you just want the basics and in plain English? Do you know there are civil and criminal penalties even for the rank and file staff member! Do you know what you can and can't do with protected health information? 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 fruit 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

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: Joint Commission standards set a high bar for hospital medical staff bylaws. Since the 2011 changes to MS 01.01.01, bylaws must meet 37 elements of performance including hearing provisions, credentialing requirements, department director duties and more. But don't stop there-additional requirements are scattered through other Joint Commission standards. Each standard, element of performance and their quirks will be addressed and means of compliance explored. Why should you Attend: Joint Commission accreditation, sought by the overwhelming majority of American hospitals, hinges upon compliance with the Standards and their Elements of Performance set forth in the Joint Commission Accreditation Manual for Hospitals. Some of the most complex, detailed standards involve medical staff bylaws provisions and processes. Federal legal requirements change frequently in ways that unexpectedly affect these Joint Commission standards. This webinar addresses the most up -to-date Joint Commission requirements and industry best practices for medical staff bylaws compliance. Areas Covered in the Session: Joint Commission Standards for Hospitals Medical Staff Bylaws Hospital accreditation requirements Who Will Benefit: Medical Staff President Bylaws Committee Chair Chief Medical Officer Vice President of Medical Affairs Chief of Staff Director of Medical Staff Medical Staff Attorney Hospital Counsel Medical Staff Manager Speaker Profile Elizabeth A. Snelson represents medical staffs across the country, focusing on medical staff bylaws, and works for medical societies on medical staff issues. A frequent speaker on medical staff legal issues, Ms Snelson presents at medical staff leadership retreats, and in programs sponsored by state medical staff services associations and medical societies, the American Medical Association, the American Bar Association, and other organizations. She is Past President of the American Society of Medical Association Counsel, Vice Presi

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

Cervical orthosis Ethafoam is an advanced collar with scientific design which ensures complete immobilization on one hand and perfect comfort on the other. It is called as a gold standard in cervical immobilization. Ultimate comfort. Perfect immobilization. Anatomically moulded. Minimal contact surface. Hypoallergenic. Cervical Orthosis (Philadelphia) Ethafoam Features Pre-formed chin Provides rest to the chin, ensures comfort, improves immobilization. Anatomical and balloon design Offers perfect immobilization, minimal contact of the neck, allows use in burn or trauma patients. Hypoallergenic materials Ensures no rash or allergy even on prolonged use, compatible to geriatrics, better patient compliance . Tracheotomy opening Compatible to use of endotracheal tube, improves air ventilation, improves patient comfort and compliance. Two piece design Easy application, firm occipital support, option for varying rigidity. Ethafoam Light weight, better patient compliance, non absorbent ensures easy cleaning and maintenance.

Tynor Cervical Orthosis Plastazote Cervical orthosis plastazote is an advanced collar with scientific design which ensures complete immobilization on one hand and perfect comfort on the other, It is called as a gold standard in cervical immobilization. Ultimate comfort. Perfect immobilisation. Anatomically moulded. Minimal contact surface. Hypoallergenic. Tynor Cervical Orthosis (Philadlphia) Plastazote Features Pre-formed chin Provides rest to the chin, ensures comfort, improves immobilization. Anatomical and balloon design Offers perfect immobilization, minimal contact of the neck, allows use in burn or trauma patients. Plastazote Light weight, better patient compliance. Non absorbent ensures easy cleaning and maintenance Hypoallergenic, Ensures no rash or allergy even to old age patients Eco friendly manufacturing process Better patient compliance Tracheotomy opening Compatible to use of endo tracheal tube, improves air ventilation. Improves patient comfort and compliance. Two piece design Easy application, firm occipital support, option for varying rigidity. Better immobilization Tynor Cervical Orthosis (Philadlphia) Plastazote Measurements Measure distance between edge of sternum and lower jaw with neck in extension position.

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: 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: This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices and personally owned 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: Update

Social media and healthcare: The advent of the social media into the healthcare industry has thrown open a hitherto unknown dynamic. It presents the industry the kind of opportunities that were hard to come by till now. Yet, it is full of challenges. It is now an inescapable fact and a given: the onslaught of the social media into the healthcare industry cannot be reversed. The wave is too strong to resist. The explosion in the use of social media has impacted the healthcare industry on a scale that is unprecedented. The universal pervasiveness of the social media Social media and healthcare have become great buddies mainly because of the sheer power of reach of the social media. What started out essentially as services that shared photos and messages has turned out to be a giant opportunity for the healthcare industry. Today, it is something that no one in the healthcare industry -or those outside it, such as the lay young population that seeks medical information - is insulated from. Now, not only patients, but also physicians and everyone of any significance in the healthcare industry use the social media to disseminate information. Social media and healthcare have become strongly paired also because they help in keeping the patient in close contact with the healthcare provider. It is no surprise that the social media have broken the barriers of age and geography in reaching out to the highest and widest range of users. Some trends about social media and healthcare: It is estimated that a fifth of the entire American population exchanged medical information over the social media in 2010 About three-fourths of all patients use the social media for some information before reaching a healthcare provider At least a thousand top US hospitals use social media for communicating with patients and providers Globally, up to half a billion people could be linking social media and healthcare by using the former Now, the challenges: Despite social media in t

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

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

Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives

Tynor Cervical Collar Soft Cervical collar soft is used for supporting the neck and protecting it against jerks impacts and vibrations. Recommended where a partial or controlled immobilization of the cervical region is required. Ultimate comfort. Partial immobilization. Optimal support. Excellent aesthetics. Absorbs impact. Tynor Cervical Collar Soft Features Soft polyurethane Provides unmatched comfort, used as prophylactic collar, reduces pain and provides comfortable support during traveling. Covered with hypoallergenic cotton stockinet. Better patient comfort, no allergy or rash even to sensitive skin, better compliance No hard, bony reinforcement Improves patient comfort, particularly recommended for geriatric patients, excellent for prolonged use. Anatomical design Uniform support to the mandible, effective action and better fit, better comfort. Perforated collar body Improved ventilation, more patient comfort, better compliance.