In this webinar you will learn how perspective taking is a fundamental concern when treating Asperger Syndrome/High Functioning Autism, At the completion of this presentation, you will be able to view your clients diagnosed with Asperger syndrome/High Functioning Autism in a different manner, You will be able to develop strategies to help them achieve success, not only in your office, but also in any social setting.
This webinar will focus on the Stark Law's underlying technical requirements and key tenets of defensibility as they apply to physician practice acquisitions, also will discuss best practices for drafting physician employment agreements, related compensation plans and facilitating effective onboarding
This HIPAA Cyber Crime Training will discuss how to use the HIPAA rules to prevent, prepare, respond and recover from Cyber Attack , Ransomware is the easiest and safest way for cyber-criminals to extort money from the Healthcare Industry.
This session will explore the complications and requirements of each of the rules controlling student health information, HIPAA, FERPA, and 42 CFR Part 2, and provide insights into how to apply the rules in an education setting.
Recent cases and/or enforcement actions involving the Federal Civil False Claims Act (FCA) as well as the Medicare-Medicaid Anti-Kickback Statute (AKS) and/or Federal Physician Self Referral Law (Stark II) raise serious concerns regarding compliance issues with the hospital, physician practices, and other healthcare entities.
Importing FDA regulated products requires careful planning before you even start. Registration, product compliance, record and data submission must be exactly correct or your product will be detained.
Likewise, the U.S. Customs and Border Protection (CBP) must be precise or your entry is not going anywhere. Some mistakes are common, others reflect a lack of understanding of how FDA and Customs and Border Protection (CBP) operate a joint program.
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc.
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.
FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed.
The world is swimming in data yet raw data is mostly useless without methods to turn this data into useful and actionable information.
Those individuals and companies that make best use of the available data achieve a competitive advantage by optimizing their operations and making superior decisions. Companies that fail to take advantage of data are resigned to chasing rather than leading in this information age.
However, most analysts and decision makers do not possess enough knowledge in statistical methods to effectively use their data and they often find it difficult to interface with statisticians at their disposal.
Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees.
Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity.
This webinar will begin with a general discussion of technical writing and its role within the life sciences. Technical writers produce a variety of technical documents that are required to manage and direct regulated operations and to meet regulatory requirements. We will spend some time in this webinar discussing those document types, their importance, and the consequences of the messages are unclear or misunderstood.
After setting the stage for this content, we delve into the writing process beginning with the audience and how the audience must be analyzed to determine the level of writing that must be employed to complete the document.
This 6-hour seminar will cover the latest SAMHSA and HIPAA updates which were released in January 2018 and December of 2017 respectively, and also cover multiple scenarios and FAQ’s relating to Substance Abuse Records, Mental Health Records, Alcohol Abuse Records, and the proper ways to secure this information and/or release this information.
An overview of a comparative analysis will be presented comparing SAMHSA to the HIPAA laws relating to protected health information in general.
Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to "listen" to their processes so that potentially harmful changes will be quickly detected and rectified.
However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Highly effective SPC programs combine technical competencies, such as using an appropriate chart and sample size for the application, with effective management techniques such as enabling operator buy-in and involvement. This webinar provides a comprehensive introduction to SPC methods and tools to help you deploy an effective SPC program.
This 6-hour webinar takes the participants through HIPAA compliance from start to compliance.
The first presentation explains the history of HIPAA, why it came into being and its evolution. This covers what HIPAA is, what steps have to be performed to be HIPAA compliant and what HIPAA compliance is. It also provides definitions to key HIPAA terms, how to define a Business Associate and how to contract with Business Associates.
The second part of the first presentation is an overview of how to manage the HIPAA compliance project.
This 6-hour virtual seminar includes a presentation of the steps and techniques used to quantify variability in manufacturing processes, and to assure quality products.
The concepts and information presented will be mainly concerned with statistical process control: obtaining monitoring information (data) that is objective, unbiased, and useful for decision making. An emphasis will be placed on the set-up and use of control charts.
If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.