Compliance Training Webinars for Regulated Industries

Importing FDA regulated product faces new challenges, new risk management procedures, and mitigation of business consequences that will affect corporate profits. Basic issues should be evaluated and updated to help you plan for unprecedented problems and your helplessness to escape the trauma. The COVID-19 creates a global bondage on commerce and drains, if not dries up, the supply of necessary products to protect the health and well fare of your customer base, which actually is the entire U.S. population. In this webinar, you will mentally travel through your import process, how it will or can be derailed and identify issues you need to evaluate during the current interruption of your standard import business.

This session focuses on the issues of managing release health information when it may involve substance use disorder treatment information. We will explain how HIPAA relates to information management and release and explain the processes required for various releases of information under the HIPAA rules, including release according to individual access requests, and under consents and HIPAA authorizations.

Preclinical development is a critical stage of drug development that determines as well as measures the “therapeutic” doses needed and the ability to achieve these doses. Moreover, preclinical studies assess the safety of the drug at these doses.

This webinar is designed to help companies develop cost effective and sustainable safety management strategies. Topics covered include; management responsibility, worker engagement, continuous improvement, consensus standards and how to move from second class to world class.

Artificial intelligence (AI) has become a strategy to turn smart tasks into game-changing tools and technologies for healthcare providers. This has been documented in the processes of coding, diagnosing some diseases, and has assisted financial teams in identifying outcomes that would have all taken many hours by staff performing these tasks. Coupled with the right expertise, AI has been shown to be effective in case management departments, as well-especially with the utilization management process.

Lots of energy are being spent on ensuring that IT systems in financial institutions are 'safe' or can be declared as such to the public. However, we have to observe a gap between what needs to be told and the cyber-risks that are actually incurred by financial institutions. In this webinar, we keep away from the technical considerations which, as useful as these may be, inevitable end up in the dead-end when confidentiality has to be alleged. Instead, we challenge where the approach may err: when cyber-security teams have to keep their specialist knowledge to themselves instead of enrolling the other functions of the bank into a cyber-security systemic approach which can cover cyber-risks whatever their sources and natures: from organized crime to internal negligence, and including reputational risks.

The new medical device regulation EU MDR 745/2017 in the European Union has a lot of new requirements. One of those requirements is Article 15 Responsible Person for Regulatory Compliance. That role is a little bit similar to the role of the Qualified Person in the Pharma Industry but not the same and the new role is not the same as the Quality Representative for the quality management system. Your company must implement the new role in the organization structure and in the processes and take care of the qualification requirements.

This webinar will discuss how to most effectively and efficiently comply with the complex maze of FinCEN rules and regulations for MSBs (Money Service Business). Compliance does not have to be onerous and time-consuming. Discover tools and techniques that can simplify your processes while minimizing regulatory scrutiny.

Change does not have to be hard and in the course of thes webinar we will explore the causes of change in this VUCA age we are in. We will also look at the difference between a stakeholder and a shareholder and their impact on change. Along with the strategies to handle change we will also look at the various stools available to guide you along the way.

USMCA addresses recent and critical emerging issues, such as harmonization of regulatory systems, e-commerce, rules of origin, protection of intellectual property, and dispute resolution. These changes in USMCA will affect your operations and therefore, it is critical to understanding the key differences between NAFTA and the USMCA.

Accelerated assessment of medicines in the EMA’s centralised procedure may be granted for treatments that are of major interest to public health. It is one of a number of regulatory mechanisms designed to provide early access to new drug treatments.

Attend this webinar to get Step by step instructions on creating your department’s strategy utilizing agile principles. It will cover a Simple straight forward process you and your team can execute with ease. We start with a 360 degree analysis of your stakeholders, high light priorities, align to the larger organization goals, identify risks and roadblocks, create meaningful measurements, and develop the 2020 roadmap.

Now that the New Family First Coronavirus Response Act (FFCRA) and Coronavirus Aid, Relief, and Economic Security (CARES Act) is in place it is critical for Employers and Leaders to be knowledgeable about the impact and the compliance consequences. Although there are many updates provided by many different resources, it is imperative that Employers and Leaders count on the experts to explain health resources and compliance experts to assist them with the regulations since they are happening and changing daily. Moreover, as Employers mistakenly shut down training costs, they are doing a disservice to the company and to their employees. Research has proven that compliance training is the lowest cost/high value risk management Strategy. Training Leaders has provided a huge resource on how companies can prepare for the transition during and after the COVID_19 Pandemic.

Most of our decisions are made with incomplete information, which leads to uncertainty and anxiety about the outcomes. Risk-based decision making is a rational, explainable and defensible way of making decisions. The knowledge you will gain is applicable to all areas of work and life.

Managing case management outcomes and the creation of tool with which to study those outcomes is an important component of the work that case management professionals must engage in. This data helps us to better understand where we are doing well and where we might need to improve. Case management report cards are also a useful tool for reporting data to the Utilization Committee, a requirement under the CMS Conditions of Participation for Utilization Review.

This webinar will cover the new paradigms for designing for design for reliability and durability. It will discuss how to plan for Zero Defects and long minimum life at little or no cost resulting in very high return on investment. It will cover real aerospace and industry examples from the instructor’s consulting experience.

For healthcare facilities and long-term care facilities looking to promote employee safety in the workplace, this webinar will provide essential information on structuring your employee health program as per Center of Disease Control (CDC), Occupational Health and Safety Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and the National Institute for Occupational Safety and Health (NIOSH) recommendations.

This webinar covers the key requirements for CRO oversight compliance with the latest focus on GCP inspection in this area including during the challenging environment of COVID-19.

Analysis of samples supporting a clinical trial requires familiarity with the clinical protocol, at least at the sample management and bioanalytical PI level. This understanding improves lab efficiency and regulatory and legal compliance.

The main goal of food safety management is the reduction of the incidents of foodborne illness to the lowest practical level. This can only be achieved by taking steps at each point of food chain where hazards can occur. Limited resources at regulatory and local level mean decisions must be taken regarding which actions are prioritized. Risk analysis is the tool to determine such actions.