Health and Environment Training Classes

Professional communications involving Protected Health Information must be conducted securely, according to guidance from HHS and any reasonable Risk Analysis required by the Security Rule, so any office communications must be carefully controlled to avoid breaches of PHI.

Overview: This seminar is designed to provide intensive training in HIPAA Security and Breach Notification Rule compliance designed for both the seasoned HIPAA professional as well as the individual newly appointed to the position of HIPAA Security Officer. The session begins with a detailed examination of HIPAA Security Rule and Breach Notification requirements, including what you need to do to protect information and what you have to do if you don't.

Overview: This session is designed to provide intensive training in HIPAA Privacy Rule compliance designed for both the seasoned HIPAA professional as well as the individual newly appointed to the position of HIPAA Privacy Officer. The session begins with overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, such as Individual Rights and Uses & Disclosures, and recent and expected changes to HIPAA and other rules such as 42 CFR Part 2 regarding Substance Use Disorder information, including the impacts of required changes in your practices to meet the rules.

There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed. The second phase considers what must be considered during the audit itself. Audits conducted by inexperienced or ignorant auditors are often worthless, wasting the time and money of both the auditors and the laboratory being audited. Auditors who are familiar with laboratory operations are needed as it is easy to be fooled into thinking that a non-compliant laboratory is operating normally.

In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.

This combined DMF (Drug Master Files) and Quality Agreement training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers. The root of many of the problems lie in a lack of a suitable agreement delineating roles, responsibilities and resolution to agreement to these issues. Part of these arrangements typically involve the development, support and updating of confidential technical files (Drug Master files), which allow suppliers to protect their confidential product and process information from each and every customer and share it only with the Agency.

Gain the insights and skills to know where your business stands today and where it’s heading tomorrow. In today’s unpredictable business environment, strategic leadership is not just for top management alone. It’s for: Managers who may be managing their entire team remotely, particularly for the first time Managers who want to increase their competitive advantage by anticipating their customers’ priorities, needs and expectations Managers who want to distinguish operational data from strategic data, creatively develop sources of information and increase their staffs’ flexibility and responsiveness Managers who want to broaden their perspective, improve flexibility without compromising quality and increase their department’s value to the organization Every manager who wants to anticipate, initiate and manage change for maximum competitiveness!

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Overview: In this session Mr. Wolfe will provide an overview of the Anti-Kickback and Stark Laws and their fair market value and commercial requirements. He will distinguish between what is legally required, what is a developing best practice and finally, will discuss common misunderstandings and misconceptions related to fair market value and commercial reasonableness in the industry.

Overview: Learn how to deploy effective revenue cycle work from home solutions that will drive performance improvement efforts. Why you should Attend: With the rapid work from home shift, provider organizations are now trying to fine tune existing work from home solutions or develop effective plans / solutions to deploy staff remotely. Areas Covered in the Session: Technology Aspects Staff Monitoring Options Effective Process Management in a Remote Setting

Overview: In this webinar session Mr. Wolfe will discuss the technical requirements of the Stark Law as it applies to physicians. He will discuss best practices for negotiating and drafting contracts and compensation plans, including common provisions and potential pitfalls to avoid.

Overview: OCR issued important and useful guidance to Providers reviewing HIPAA rules for disclosures of a patient’s protected health information (PHI) during the COVID-19 Public Health Emergency. The guidance includes disclosures to family, friends and persons involved in care; disclosures to public health authorities, first responders, the media and disclosures to prevent or lessen a serious and imminent threat to the health and safety of a person or the public. Although OCR announced it will not impose penalties on health care providers for noncompliance with certain requirements related to telehealth, it emphasized that most HIPAA Rules protecting the privacy and security of patient information remain in effect and will be enforced. Nevertheless we have seen COVID-19 related disclosures HIPAA privacy violations. This webinar will cover OCR’s guidance for disclosures of PHI that it is continuing to enforce.

Overview: The intent of this webinar is to dispose of the hype, bring out the migration and operational issues to provide a clear strategy outline for moving forward with a blockchain solution Go-No Go decision and then making the right moves to actualize it. Why you should Attend: In recent times, blockchain technology - usually in the form of cryptocurrency - has been extolled as the latest in a series of "silver bullet" solutions to certain nagging problems: supply chain and inventory control, records management, authentication, electronic contracts, and similar needs where tracking, item integrity and ownership, and authentication of claimed identity are of highest concern.But what to consider and how to decide?

Overview: Scientists, Design Engineers, and Manufacturing/Process Engineers must develop product and process specifications that ensure that products delivered to customers perform their intended functions over time. If specifications are too wide,the risks of inadequate product performance and product failures increase. If specifications are too tight, the costs to ensure conformance increase.

Overview: The course includes activities to help trainees develop a general plan and procedures to standardize and control food quality and safety transportation processes. For food shippers, carriers and receivers, standardization or upgrade to current practices is critical. For buyers, knowing how to establish standards for your food transporters sets the stage for required supply chain controls. The journey from "Where do we start?" to "We are compliant food safety carriers." begins here and establishes a basis for meeting newly evolving FSMA food safety during transportation requirements.

Overview: Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

This webinar demystifies Part 11, and get you on the right track for using electronic records and signatures to greatly increase productivity, and explains about the regulation and how it applies to computerized systems.

In this webinar speaker will explain about CAPA System, A company's CAPA System is supposed to be a major tool in resolving product complaint, non-conformance, and focusing OOS failure investigations, and hazard analysis / risk management and mitigation activities, And Failure Investigation and Root Cause Analysis are the foundation for proper CAPA, verification and Validaiton, Inspection / Audit resulutions, and other basic CGMP requirements.

The webinar will provide important considerations when selecting sample sizes for specific applications.

There are two phases to this topic. The first is auditing itself. Good audits are well structured. They must consider the reasons for the audit, the regulatory requirements, as well as the nature of the laboratory being audited. We will discuss the considerations that must be made when auditing a laboratory. The social interactions that must be expected, the nature of the regulatory requirements and the nature of work that the laboratory performs will be discussed.