Public Education

GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful. GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you. http://bit.ly/Courses-June-to-July-2017

Compliance4All webinars are just what professionals in the regulatory compliance areas need for scaling up in their careers. With a collection of the most erudite experts on regulatory compliance being available at a click in the comfort of your preferred location; regulatory compliance could not get any simpler and effective! Compliance4All’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you. Compliance4All’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work.

Overview: The webinar will cover how to find out if business associates have the necessary technical, physical and administrative safeguards in place to protect shared protected health information. The webinar will address when a vendor becomes a business associate and how that relationship may change the dynamics. Understanding the Business Associate Agreement (BAA) process and making sure all ten government mandated requirements are in place will be covered. Find out about the use of Vendor Security Questionnaires and how to implement. The webinar will cover breaches caused by business associates and how to handle such an occurrence. If your healthcare organization needs to understand what your responsibilities are in managing business associates, please join us for this informative and interactive course

HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas, help assess the effectiveness of current HR management activities, help assess weaknesses in HR internal control processes, and help assess human capital strategic and compliance related risks. HR audits should additionally provide suggestions for corrective action. Importantly, HR audits should consider human capital related risks and opportunities from an enterprise risk management (ERM) perspective. That is, your HR audits should take a holistic approach in assessing human capital risks and attempt to indicate the interrelationships and interactions between

Developing Technical Training in the Life Sciences is a 2-day seminar that addresses the unique challenges of developing and managing training in Life Sciences companies. The Life Sciences pose unique challenges to training developers. The first day of this seminar will concentrate on providing foundational knowledge concerning training and development within the Life Sciences. Four 90 minute sessions will be presented on this first day that will guide the participant from a discussion of the role and function of the technical training function to the actual creation of the training organization. Important to this first day, are discussions of performance-based training, the fundamentals of training (jobs, duties, tasks, and steps to include performance objectives) and how human performance and training are inextricably linked. Knowing about human performance and how to apply human performance principles are crucial to designing, developing, and managing an effective technical

Gaps and/or incorrect or incomplete implementation of safety functionality can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all the steps necessary to design, implement and test critical medical devices in a regulatory compliant environment. This course will additionally address the software risk management and the resulting interfaces to device level risk management. To comprehensively summarize all risk related activities and to demonstrate the safe properties of a device, the 'Safety Case' or 'Assurance Case' document is a well-established method to collect all safety related information together in one place. This documentation will most likely become mandatory for all devices (currently onl

If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. Statistics of course, requires constant practice. This seminar will be highly interactive and participative. Participants apply their learning of statistics to real-world example data sets. The program begins by providing a basic overview of the most common statistical tools and terms. By the end of day two, course participants will have acquired the skills necessary to read and understand statistical reports contained in the CMC section including statistically sound sampling plan. One of the outstanding features of this learning session is that throughout its duration, it will allow complete interaction of the participants with both an expert instructor and their peers.

The FDA has placed significant emphasis on the role of Human Factors in the approval of devices used for medical purposes. There are several current guidance documents and new proposed Draft Guidance documents. This seminar will compare these Guidance documents. Additionally, strategic recommendations will be presented on how to implement these requirements into the medical device design, development and approval processes. Finally, Human Factors methods and best practices will be covered that the FDA is requiring. Why should you attend: Are you familiar with the role of Human Factors with respect to combination products and the FDA requirements? Are you current on the FDA's current perspectives on Human Factors? Human Factors has become increasingly important to the FDAs approval of medical devices. It is a part of the design and development of the device and the collateral information, e.g., labeling, IFUs, and training. Incorporating Human Factors into the device development proce

A thorough understanding of the complexities involved All the relevant regulations and guidelines Real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing

I will be speaking to real life audits conducted by the Federal government for Phase 2 and beyond (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). It seems almost daily I am receiving calls from nervous practice managers and compliance officers all over the USA regarding a HIPAA audit letter or call they have received. 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 2017.

This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. Many companies are outsourcing IT resources and getting involved with Software as a Service (SaaS) and cloud computing. These vendors are not regulated and therefore regulated companies must ensure compliance for both infrastructure qualification and computer system validation. It is the regulated company that wants to avoid FDA form 483s and warning letters. The seminar is intended for regulated companies, software vendors, and SaaS/Cloud providers. The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation. Today the FDA performs both GxP and Part 11 inspections, the Europeans have released an updated Annex 11 regulation that expands Part 11 requirements and companies

Development of a safety program to save costs, delayed schedules and the human cost of injury or death. Safety management guidelines and techniques for the engineering, construction, and scientific professions. Includes costs of preparing the necessary safety documentation. It will emphasize using multiple techniques for each safety task. It will discuss costs of professional services from consultants. There will be brief exercise each day. The course will discuss the costs of accidents in an occupational environment. It will discuss the costs of operating industrial and construction projects safely in accordance 29 CFR 1910 and 29 CFR 1926. Discussion of how Environmental releases and safety violations can impact your profitability. How accidents affect production schedules and result in civil or in some cases criminal action. Multiple safety violations can cost your company hundreds of thousands of dollars.

This 2 day seminar will explore how to create and implement an efficient and effective internal audit program. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing quality and compliance risk. However, estimates indicate that up to 75% of companies conduct audits only because they are required to by regulation. Businesses often see internal audit as a non-value added activity leading to meaningless findings, bureaucracy, and cumbersome processes. And despite having an internal audit program, management is often surprised when they receive a 483, Warning Letter, or even a Consent Decree. A well planned audit program can reduce these risks.

Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that 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 a 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 two-day training course.

HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas help assess the effectiveness of current HR management activities, help assess weaknesses in HR internal control processes, and help assess human capital strategic and compliance related risks. HR audits should additionally provide suggestions for corrective action.

This course covers a very broad range of topics from worker classification, to employee classification, to establishing methods and rates of pay, what must be included in the rate of pay, hours that must be compensated as worked time, required benefits, de minimus working fringes, withholdings and deductions from pay, voluntary deductions, child support and garnishment orders, payroll reporting, analysis of risks of noncompliance, proper documentation of your policies and procedures and record retention requirements. We will show where to find the laws, how to interpret them and how to apply them in the most effective ways.

Upon completing this course, participants should: Understand the limitations of the current exploration process Learn to use lineament and satellite interpretation as a way to define where to concentrate their exploration efforts How to implement QA&QC; procedures to guarantee the quality of the collected data Why you should attend: We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. Even over new areas with limited or nonexistent geological information, we are able to help you concentrate your exploration efforts to keep your budget in the black. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901014SEMINAR?trainingregistry_SEO

This course provides a basic description of an FDA regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful strategies for medical devices, including definitions and classifications, elements of regulatory strategy, sources of regulatory intelligence, selection of development and product clearance/approval pathways. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900902SEMINAR?trainingregistry_SEO

Gaps, incorrect or incomplete implementation of software can delay or make the certification/approval of medical products impossible. Most activities cannot be retroactively performed since they are closely linked into the development lifecycle. Diligent, complete and correct implementation of risk management from the start of product development is therefore imperative. This course will introduce all necessary steps to design, implement and test critical medical device software in a regulatory compliant environment. Software risk management has to be embedded into the bigger scope of overall risk management. Therefore this course will additionally address the system level risk management and the resulting interfaces to software. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900890SEMINAR?trainingregistry_SEO

Defining the basic requirements of Good Clinical Practices Clinical Study Protocol Elements and Device Accountability Role of Institutional Review Board (IRB) and Informed Consent Principles of Ethics and Quality Control Determining the appropriate duties and oversight required of the sponsor, monitor, and investigators to ensure a high level of quality in a clinical trial Ensuring that quality practices are designed and implemented to guarantee compliant clinical trials Learning how to effectively manage a Sponsor, as well as, an FDA GCP inspection Developing mechanisms to uncover and preclude fraud and misconduct in clinical trials And Much More... Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900978SEMINAR?trainingregistry_SEO