On-Demand Webinar
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..
Food Labeling In MX
General Mexican labeling specifications for pre-packaged foods and non-alcoholic beverages have been submitted to different changes due to health policies in Mexico. In order to comply with the new guidelines, you’ll need to cover numerous rules, standards, and some other regulations.Receive the most up-to-date information first-hand from an industry expert that collaborated through the ICC in the most rece..
Food Waste Reduction: The road to Cost Reductions and Sustainability
Food waste is a well-recognized issue throughout the food supply chain. Loss estimates run anywhere from 30% to 50%. Water, fertilizer, manpower, facility overhead costs, delivery/planting/production/storage and delivery, carbon emissions, environmental pollution, and other food production expenses are lost along with the food that cannot be consumed.Food waste, as defined by the U.N.’s Food and Agriculture..
Form 1099 Compliance Changes for 2020
The IRS has introduced a new “old” form for 2020 — the Form 1099-NEC. This form was used years ago to report contract labor, but was retired after the 1982 tax season. It is now being brought back for 2020 and is where contract labor payments will now go. No longer will those payments be reported in box 7 of the 1099-MISC. This webinar will cover: who needs to file a 1099-MISC or 1099-NEC; what payments are..
Form 941 for 2018: All You Need to Know
This webinar covers IRS Form 941 and its accompanying Form Schedule B for 2018. It discusses what is new for the form in 2018 and covers the requirements for completing each form line by line. It includes the filing requirements and tips on reconciling and balancing the two forms. The webinar also covers the forms used to amend or correct the returns.Form 941 is the link between your payroll records and the..
Form I-9 Compliance Issues Every Employer Needs to Know
Identifying for employers compliance issues which they need to address in order to be in the best possible position to defend an I-9 audit by Immigration & Customs Enforcement (“ICE”). Form I-9 compliance goes beyond just filling out the form. It requires that every business have Form I-9 Policies and Procedures in place that cover topics such as properly making corrections on a Form I-9, storage of For..