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FDA Deeming Rule for Tobacco Related Products and Recent Actions: eCigarettes, eLiquids, Cigars
This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.You should attend this webinar..
FDA Import Program with COVID-19
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 ..
FDA Inspections: Prepare and Survive
FDA conducts establishment inspections to determine a firm’s conformance to applicable regulatory requirements. Inspections vary based on the type of product you make or plan to make. FDA prioritizes domestic and foreign inspection assignments based on three factors. However, with the current public health crisis with COVID-19, FDA is overwhelmed with work at this time, so it will likely rely on new approac..
FDA Meeting Requests , Preparation and Conduct
The FDA has published guidance regarding the types of meetings that will generally be granted and the information needed to conduct the meeting. However, the guidance tends to be general and interpreted in multiple ways. This topic will provide practical examples and suggestions for standard meetings as well as requesting and conducting non-typical meetings (such as during fast track, the clinical hold, or ..
FDA Regulations Associated with the Detection, Correction and Prevention of Human Errors in GMP Manufacturing and Laboratory Processes
We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper. We will focus on improved techniques to get to the real cause of the problem. With this information, you will be able to develop meaningful CAPAs that have a chance to remedy these proble..
FDA's Recent Clarification on Guidance for Managing Data Integrity for Regulated Systems
Effective and compliant computer system data management is critical to organizations in the pharmaceutical, biologics, vaccines, tobacco, animal health, medical device or other FDA-regulated industry. During the past 30 years, best practices have been developed to ensure computer systems used in these environments can be cost-effectively managed while meeting all aspects of FDA compliance. To take this a st..
FDA’s and U.S. Custom’s Import Entry Program
The webinar address the critical elements of information required to present a product for entry into the U.S. We will cover what information for FDA is mandatory. You must use the new software program, Automated Commercial Environment (ACE), you need to decide on who will do that, establish operational procedures and what to do if your entry is detained. The course will explain how you can make your ..
FDA’s Cloud Compliance and Regulations
The evolution of computerized technologies has been both amazing and challenging. Each new wave of technological evolution has been accompanied by a series of compliance challenges, and subsequent strategies to comply with applicable regulatory requirements. Cloud computing is a current example of this evolution. This presentation will provide a discussion of Cloud concepts, terminology, definitions, archit..
FDA’s GMP expectations for Phase I & First-IN-Man Clinical Trials
This Webinar will provide details on GMP requirements throughout all phases of development and commercialization.Following Good Manufacturing Practices (GMPs) is a mandatory legal requirement from clinical studies through-out marketing. Early clinical trials are conducted to establish the initial safety of a drug. The studies are generally in a small number of healthy subjects and use lower doses of the dru..
FDA’s Scrutiny of Social Media and Corporate Responsibility
Off-label promotion falls within the scope of labeling requirements as defined by the Federal Food, Drug, and Cosmetic Act, as amended (FDCA). FDA’s application of labeling requirements to the information posted in social media of any type creates a new field of enforcement opportunity, one that may catch you by surprise. If off-label statements, whether express or implied, end up directly or indirect..
Federal Family Educational Rights and Privacy Act(FERPA) in AY 2020 - 2021
The Federal Family Educational Rights and Privacy Act of 1974 (FERPA) governs the disclosure of student records and information. If any faculty member, administrator, department, or office maintains records on a student, those records are educational records and must comply with the laws and regulations under FERPA. Often, College and university faculty and administrators are not familiar with the req..
Federal Regulatory Update: What is going on with the Alphabet agencies? (EEOC, NLRB, OFCCP, etc.)
Like many people, I did not believe that Donald Trump would win the presidency and I assumed that we would continue to see, at the very least, a continuation of President Obama’s progressive and aggressive agenda. What we ended up with, however, is a new administration that is fundamentally different from the previous one. While there continues to be much rhetoric, it is clear that the Trump Administration ..
FinCEN's CDD Rule - Fifth Prong of the AML Program
FinCEN has issued substantial new AML requirements focused on a major expansion of Know Your Customer into what is now Customer Due Diligence, CDD. It goes far beyond knowledge of the Customer Legal Entity to the Beneficial Owner of that entity and its Controlling Persons. It is focused beyond the initial customer acceptance step, requiring updating and ongoing monitoring against baseline “normal” activity ..
FIRPTA Tax Planning and Compliance After Tax Reform
This program will provide the participant with the U.S. federal income, estate, and gift tax implications and planning techniques to properly advise their foreign investor clients on how to best structure their U.S. real property investments under the new tax rules of the Tax Cuts and Jobs Act.Advising foreign real property investors requires tax and other professionals involved with foreign real property i..
Five Reasons Your Hiring Practices May be Illegal and Ineffective
This webinar covers five reasons hiring practices may be ineffective or illegal or both. We will talk about “warm body” hiring and how to avoid it. We will discuss the importance of understanding the job and how well the candidate matches the requirements. We will discuss how to interview better and how to assess the candidate. The importance of background checks and their proper use will be discussed to av..