Attend this 90 minutes presentation to gain a fundamental understanding of
FDA's regulation of Dietary Supplements, Dietary supplements are regulated products, also Dietary supplement marketing, manufacturing, labeling, and advertising are all covered by regulations enforced by FDA.
Why should you Attend:
There is confusion in the industry as just what type of manufacturing
controls and record keeping, and labeling content is required by the FDA,
and this confusion continues to cause regulatory problems for many new
and established companies in this industry.
Over application or incorrect usage of lubricants can lead to insanitary
conditions or contamination. Often condensate plays a big part in
refrigerated foods and mixed with improper use of lubricants can spell
potential problems in the environment.
Why should you Attend:
FDA at one time approved and updated a lubricant listing for the food
industry. This is now the responsibility of manufactures to manage.
In this webinar speaker will explain how to choose the tests to be conducted
and the studies that must be completed prior to the actual validation test.
Why should you Attend:
We will explain how to choose the tests to be conducted and the studies
that must be completed prior to the actual validation test. The post test
participant inquiry is critical to validation success. we will describe how to do this.
The webinar will have the answers. And using industry proven case studies on how to avoid 483 inspectional observations and warning letters attendees will learn how to prepare their organization for trouble-free Part 11 related inspections.
Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.
The concepts and information presented will be mainly concerned with statistical quality control: obtaining 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 and acceptance sampling systems and procedures.
This session will describe the information security compliance process, how it works, and how it can help you decide how to integrate e-mail and texting into your organization in a compliant way, learn how to use an information security management process to evaluate risks and make decisions about how best to protect PHI and meet patient needs and desires.
In this webinar the latest guidance from the US Department of Health and Human Services on harmonization of SAMHSA and HIPAA will be explained, We will discuss what qualifies treatment that falls under SAMHSA, HIPAA allows a number of disclosures, for treatment, payment, and healthcare operations purposes, without consent from the individual being treated, also We will examine how to deternmine if the services you provide place you under 42 CFR Part 2.
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.
The Phase 2 HIPAA Compliance Audit, increasing breaches of unsecured protected health information and rampant medical identity theft reveal a national crisis in HIPAA compliance.
The Office for Civil Rights (OCR), the HIPAA enforcement arm of the U. S. Department of Health and Human Services (HHS), is ramping up enforcement. And a basic HIPAA requirement, Risk Analysis - Risk Management, is the key to protecting your business, whether you are a covered entity or a business associate.
The presentation will provide an overview of the Federal Stark and Anti-Kickback laws and corresponding regulations including the history and purpose of these laws. The presenter will provide the background upon which these laws were determined to be necessary and developed. The attendees will be provided with an overview and description of the laws, why they were instituted, what they do and do not cover and who they are and are not applicable to.
Today's diverse, fast-changing, multidisciplinary health care environment involves many health care professionals who work together for the common goal of the patient. This includes physicians, nurses, physical therapists, pharmacists, and others.
Today's diverse, fast-changing, multidisciplinary mental health care environment involves many mental health care professionals who work together for the common goal of the patient.
This includes physicians/psychiatrists, psychiatric nurses, psychologists and others. Nothing in health care is more fractured than in mental health among a multitude of mental health practitioners.
There are challenges in dealing with people who bring toxicity to the interaction. One challenge is managing the impact it has on us - the other challenge is how to respond effectively - in essence - in ways that continue to allow us to get the job done and maintain a working relationship.
In this webinar, you will learn key strategies, tactics and skills to protect your emotional and psychological well-being, while at the same time not letting the other person control or dominate.
This lesson will explain new changes on Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting and emailing of PHI.
There is a simple 3 step HIPAA "safe harbor" that frees Covered Entities and Business Associates from any responsibility or liability for unauthorized access to Protected Health Information (PHI) in unencrypted emails and text messages during transmission and after receipt by the patient.
The collection of laws and regulations known commonly as HIPAA is comprised of two federal statutes and three federal rules:
The Health Insurance Portability and Accountability Act of 1996 ("HIPAA"),the Health Information Technology for Economic and Clinical Health Act of 2009 ("HITECH"), the Privacy Rule (found at 45 C.F.R. 164.500 et. seq.), the Security Rule (found at 45 C.F.R. 164.300 et. seq.) and the Breach Notification Rule (found at 45 C.F.R. 164.400 et. seq.).