Group items matching

in title, tags, annotations or url

Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl

Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act. Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Areas Covered in the Session: Purpose of the Sunshine Act Who is required to report under the Sunshine Act? What is reported? Exclusions Tracking Penalties Useful links 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 Clinical Research Coordinators Principal Investigators/Physicians 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 fu

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: 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: New changes modifying the HIPAA Privacy and Security Regulations are going into place to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. The changes include establishing new rights for individuals as well as changes to the limitations on uses and disclosures. New requirements for patient access to records and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restriction and accounting of disclosures and increased enforcement activity. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs. And if you are required to have a HIPAA Notice of Privacy Practices, you will need to update that to show all the new rights that patients will have, such as electronic copies, new rights to restrict disclosures, and much more. Business associates are now directly covered by the HIPAA privacy and security regulations and are liable for fines and penalties if they do not comply. If a business associate supplies services that interact with the new changes to the rules, the BA will need to be aware of the new requirements. We will explain what a Business Associate needs to do differently under the new regulations. Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information - the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked in an EHR and review the various ways patient records can be supplied electronically. The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be chang

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

Course "HIPAA Security & Privacy Official - Roles and Responsibilities" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Being the HIPAA Security and Privacy Official involves not only ensuring you know 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 HIPAA Security and Privacy Official needs to understand what all the HIPAA requirements are or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive seminar. Why you should attend: The HIPAA Security and Privacy Official is the backbone of any organization's compliance program. Often times this role is assigned as collateral duty in smaller organizations. Regardless the size of an organization, the HIPAA Security and Privacy Official must know all the requirements for compliance. This is a critical element of the position. Attendees will leave the course clearly understanding the role and all the requirements as the designated as a HIPAA Security and Privacy Official. This seminar will cover reviews, creation, and amending policy and procedure. After completing this course, a HIPAA Security and Privacy 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? The Role and Responsibilities of the HIPAA Security and Privacy Official Complying with HIPAA Requirements? What are the HIPAA Security

Course "HIPAA for the Compliance Officer" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule, Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more 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 you should attend: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More im

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

Quality Assurance in Nursing Healthcare: Quality assurance in nursing is about assuring quality in nursing by ensuring that practices are compliant with quality standards. This is a full-fledged profession with its own educational and experience requirements. Quality assurance in nursing has to be understood from the standpoint of quality assurance and compliance. Quality assurance in nursing is about ensuring adherence to quality standards as mandated by nursing regulatory bodies. Quality assurance in nursing assesses what healthcare processes are in place and what else needs to be implemented to better the system. Where do quality assurance nurses work? Professionals who make a career out of quality assurance in nursing are employed in various healthcare settings. They could work in clinics or small or large hospitals. Professionals who make a career in quality assurance in nursing are licensed registered nurses. Since they are registered nurses, they should also obtain a licentiate. To get this, they should complete a prerequisite approved nursing program. The exam for getting licensure is the National Council Licensure Examination for Registered Nurses (NCLEX-RN), a computer-based examination. A higher level of education for those in quality assurance in nursing is a master's degrees inhealth care quality or a near degree. In some healthcare organizations, this is required at entry level. Some of the works they do in maintaining quality assurance in nursing include: Reviewing reports or files to make sure that activities contained in them are following regulatory clinical standards Collaborating with colleagues from other departments to which nursing is related either directly or indirectly Interacting with other hospitals or organizations, if the need arises For professionals pursuing a career in quality assurance in nursing, the ability to analyze data and manage cases is a must, as a major part of their work involves these. They should also be prompt abou

Patient Safety in Medical Education A very important aspect of medical education that had been overlooked for a long time is patient safety. When patient safety in medical education gets relegated to the backseat; the result is there for everyone to see: something like close to a 100,000 deaths at the turn of the previous century, according to the alarming results of a comprehensive study carried out by the Institute of Medicine. The tragedy of these deaths is that these were preventable. This reinforces the belief that patient safety in medical education is the core factor, which if handled properly, can save thousands of lives. How does patient safety in medical education come about? It goes without saying that physicians and other caregivers practice in their professions what they learn in schools. So, patient safety in medical education has to be incorporated into the curriculum at the earliest stages. Hospitals, medical colleges and other institutes that impart medical education have now started taking more than mere baby steps in inculcating patient safety in medical education as a core part of teaching, the already heavily burdened curriculum in medical education notwithstanding. Efforts by medical education bodies Following the publication of the IOM report, the American Association of Medical Colleges (AAMC) and the Curriculum Management and Information Tool (CurrMit) in the US and Medical Schools Council and the General Medical Council (GMC) in the UK sprang into action, announcing a slew of measures aimed at bringing about and reinforcing patient safety in medical education. Entire lessons and chapters are devoted to patient safety in medical education. Keywords and technical jargon relating to patient safety are now a highly visible aspect of patient safety in medical education. These are spread across all disciples and subjects of medical education, be it gynecology or anesthetics. What should curricula teach about patient safety in medical edu

Implementation of Regulatory Aspects of Clinical Research is critical One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: FDA requirements on regulatory aspects of clinical research The FDA has an exhaustive list of regulations relating to Good Clinical Practice (GCP), the area which forms the backbone of regulatory aspects of clinical research. The FDA has a series of regulations that are aimed at bringing in discipline and process into clinical research. It implements all the laws relating to GCP passed by the American Congress. At present, there are a huge number of regulatory standards and requirements that have to be complied with by those undertaking clinical research in the US. These regulations are codified in the 21 CFR series. Notable sections of the 21 CFR series relating to regulatory aspects of clinical research include: 21 CFR Part 11 21 CFR Part 16 21 CFR Part 50 21 CFR Parts 50 and 56 21 CFR Part 54 21 CFR Part 58 21 CFR Part 312 21 CFR 312.120 21 CFR Part 314 21 CFR Part 320 21 CFR Part 511 21 CFR Part 514 21 CFR Part 601 21 CFR Part 812 21 CFR Part 814 EU requirements on regulatory aspects of clinical research In the EU, the core aspect of regulatory aspects of clinical research relates to the primary importance given to the subjects in a clinical research. For example, regulatory aspects of clinical research France are guided by the Public Health Code and Civil Code. This Code contains a list of regulatory conditions clinicians are obliged to adhere to. These regulations are to be monitored by a number of regulation enforcement bodies that the French governm

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: The connection between the Body, its physiology and particularly biochemistry, have been linked to the mind with particular emphasis upon emotions and stress. This can be easily substantiated in common everyday situations. Anyone who has observed a facial red flush triggered by some sort of embarrassment can attest to the foregoing connection. The emotions and stress play a key role in many if not all diseases and disorders: due to the vastness of the subject, we will focus on the application of the mind/body connection(MBC) to skin. This serves as an introduction to the field of psych dermatology which, although still in its infancy in the USA, is expanding as evidence with regard to the psychological component related to the etiology of skin diseases continues to grow. Concurrently, the field of Alternative techniques IN mind/body treatments continue to grow in leaps and bounds providing effective methods for integration with conventional cosmetic and dermaceutical treatment. This provides a dual complimentary pathway both for prevention and treatment of any/most skin disorders. Expanding on this model, we have already shown how the mind influences the body as per the above example. This general proposition can be extended to include specific skin disorders such as acne rosacea psoriasis eczema and atopic dermatitis to name a few. We will concentrate on Acne for the sake of this discussion. First, focusing on the B component of the BMC model, the primary lesion associated with acne is the formation microcomodones, which are small enough to proceed undetected until larger comodones appear later in the cycle. The latter cycle is initiated by peroxidation of squalene and unsaturated fatty acids present in human sebum. This leads to the foregoing lesions and pro- inflammatory mediators such as cytokines and interleukins followed by an increase of p.acnes on the epithelial cell wall together with increased film formation of the p.acnes is the same area This

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 "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: Many infectious diseases were historically confined to specific geographical regions. However, some now pose global threats due to ease of travel, globalization of trade and commerce and global warming. Government Agencies, non-Profit Organizations, Philanthropic groups and others are also funding vaccination programs for regions where infectious diseases are endemic and to deal with new outbreaks.. Such developments are stimulating research in and the development of improved vaccines, their manufacture and control. Supply Chain complexities and stability issues need to be addressed to cope with transport of vaccines to and their use in climatically hostile regions. Programs to address such challenges need to be implemented, being resourced by appropriately trained and qualified staff from a number of disciplines. Development programs for immuno oncology products also require staffing by similarly skilled professionals. Workers currently engaged in Discovery, Development and Manufacture of conventional medications , or those seeking career-change opportunities can develop an understanding of the concepts, constraints and opportunities associated with Vaccine products by attendance at the Webinar. Engineering professionals involved in facility construction, or repurposing can also benefit as can Regulatory Affairs Professionals or staff at medicines Evaluation Agencies. The subject matter is particularly suited to professionals who are expert in the various disciplines associated with conventional medications ("so-called "small molecules") who wish to expand and develop their skills by involvement in vaccine-related programs including immuno-oncology. Areas Covered in the Session: History of and development of vaccine concepts. undamentals of vaccination Vaccine Types Administration of Vaccines Future Concepts Immuno-Oncology Vaccine Manufacture Who Will Benefit: Regulatory Affair Managers Project Management Personnel QA Managers Scientists Technol

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: 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 compliance. If your healthcare practice, business, or organization needs to understand what is required to protect health records or 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: With a substantial increase HIPAA data breaches, organizations must understand the requirements to safeguard protected health information. Attendees will leave the course clearly understanding of all the requirements that must be in place for protecting the health records their organizations maintain, create, transmit, or store. After completing this course, a Covered Entity or Business Associate 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? 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: Compliance Of