Discussions, presentations, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of mo..
We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration, or similar activity. Computerized systems that are used in FDA-regulated environments (i.e., the system “touches” an FDA-regulated product or a..
Sonia Satra's Claim Your True Power: How to Overcome Impostor Syndrome is a high-content presentation that guides participants through a simple process to help them step into their most authentic, successful, and confident selves. With her signature blend of wit, warmth, and science, Sonia tells her story about overcoming impostor syndrome to land starring roles on Guiding Light and One Life to ..
There is a proactive approach – the Action Research Strategic Planning Process - that allows teams to react to and address changes and challenges while generating the necessary buy-in and follow-through. The Action Research Strategic Planning Process is a planned series of process steps that:Obtains from the team their action/improvement-oriented proposals regarding the priority issuesFacilitates ..
The Human Resource Management Association defines a crisis as “a low probability, high impact occurrence that is often unexpected and unfamiliar.” Webster defines a crisis as any partial or complete disruption of a business’ key operations resulting in damage to equipment, property, people of the environment. While the Covid-19 pandemic clearly fits this definition so too does the recent weather impacts in ..
The webinar reviews the general concepts and basic elements of pharmacokinetics. The webinar will describe the processes that a drug undergoes after administration such as the absorption (when not administered intravenously), the distribution, including plasma protein binding, the metabolism (the bio-transformation of the drug into its metabolites), and the excretion (via the bile in faces and via the kidne..
Food Manufacturing, processing, and distribution are considered critical operations in a crisis, however, the current global pandemic has made it near impossible for food safety professionals and auditors to perform their normal routine inspections and checks. In this the session we will cover the necessity of continued inspection of our Food Chain, how GMP’s and established regulatory measures co..
The economic downturn caused by the Covid 19 virus will force most companies to sell on credit to financially weak customers in order to survive. This is a huge, unwelcome, risky change. How can a company do this and survive?Success in generating cash will be driven by the following actions/programs:Define, agree and articulate a Corporate Posture for selling to financially weak customers on credit. How acc..
The Drug Supply Chain Security Act (DSCSA) outlines requirements for pharmaceutical manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers. Some requirements began in November 2014 and several key requirements began at various stages in 2015. The requirements, development of standards, and the system for product tracing will continue to be phased in until 202..
How To Strategically Address Systemic Racism, White Privilege, And Unconscious Bias in the Workplace: It’s About More Than Training and Policy
The summer of 2020 will be long ingrained into our social and individual consciousness due to COVID and the horrific murder of George Floyd, a black man. George’s murder by white police officers, captured on video for the world to see, sparked outrage around the globe. So what, you may be asking, does that have to do with the business world. Racial bias workshops just won’t do anymore. Employers and busines..
Specific examples of several industries will be discussed, and case studies will be developed to orient attendees so they can dissect systems and processes with a view toward identifying potential hazards. A safe system will keep the probabilities of injury and fatality below a specific social threshold. The learning objective will be the prevention of costly accidents and injuries, and/or severe loss of pr..
While the government has decreased the number of itemized deductions available for people to claim, there are still many complex subjects on Schedule A that need to be analyzed. This webinar will look at these more complex issues and go through some commonly asked questions that people have on Schedule A.We will look at things like what medical expenses are deductible? Can you actually deduct a personal tra..
“Chaos, challenge, and trauma can derail us from leading a full and fruitful life." However, even in the swirl of chaos we can build our resiliency, and find our own beacon of HOPE. You will be surprised to find that hope is really not what you think it is. It is not about finding hope, it's about creating hope. How do you move from overwhelmed and frustrated to a place of RESILIENCY and HOPE?Stress is ..
Unbelievably, the Equifax data breach event occurred between May and July 2017, yet Equifax waited six weeks before its public disclosure on September 7, 2017. But it gets worse, as one month later Equifax announced that its data breach event included an additional 2.5 million individuals and then in March 2018, Equifax found an additional 2.4 million people bringing the total number of affected individuals..
Personnel in Pharmaceutical manufacturing will be asked to review many different documents. These documents are important, in that, they will be scrutinized by regulatory bodies. The aspects of writing these documents are different. The style of writing is more reader-centric, as opposed to writer-centric. Understanding the aspects of reader-centric writing is important in this industry.Areas CoveredThe Pha..