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Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics
This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (SAE) reporting requirements for OTC Drugs, Cosmetics, and Dietary Supplements. It will also cover what to expect regarding reporting changes for Cosmetics when the Personal Care Products Safety Act is passed.All OTC drugs and Dietary Supplements are required to report Serious Advers..
Advertising and Promotional Material Compliance and Review Process
The information obtained will enable the effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, strategies for mitigating risks, and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critica..
Allergen Cleaning, Validation & Preventative Risk Management
Allergens are now a Class I Recall by the FDA (Food & Drug Administration), considered an adulterant in foods. It is the largest area for recalls in the US and growing at a staggering rate. Anyone wanting to know how to approach, improve or review their Allergen Management Program should participant to understand the latest information for Best Practice preventative controls. Important elements will inc..
An Introduction to Excel Macros and VBA
A macro is an action or a set of actions that you can use to automate routine tasks. Macros are recorded in the Visual Basic for Applications programming language. The easiest way to create a macro is to record the steps. Excel stores information about each step you take as you perform a series of commands. The steps you do are saved in Visual Basic code. You then run the macro to repeat, or "playback," the..
An OSHA Inspection in the Laboratory
Do you know why OSHA would come to your lab? Do you know how to respond to an OSHA complaint or allegation? Join Dan the Lab safety Man as he discusses the steps to prepare your lab for an OSHA visit and how to properly respond when it actually happens.Areas CoveredReview the steps in OSHA’s inspection processDiscuss areas in the laboratory where potential OSHA violations are likelyCalculate possible fines ..
Analytical Techniques For Enhancing Supply Management Performance
Supply Management is about buying the right thing, at the right time, at the right quality, at the right price, from the right supplier, in the right way. In order to do these steps “right” requires skillsets in many analytical techniques. This webinar covers some of the basic analytics that purchasing and contract personnel use to obtain maximum value for their organizations. Show how Purchasing Savin..
Answering and Replying to an FDA 483
A brief introduction into the FDA 483 and its use. Responding and responding appropriately is extremely important. This is not an advanced course on 483 response but a recommended approach to best position your company to prevent even worse FDA regulatory measures. All pharmaceutical and medical device facilities who need to know how to react to FDA 483s. Properly responding to FDA observations will make or..
Antidumping and Countervailing Duties: The Nuts and Bolts
Antidumping (AD) occurs when foreign manufacturers sell goods in the United States less than fair value, causing injury to the U.S. industry. AD cases are company specific; the duty is calculated to bridge the gap back to fair market value.Countervailing duties (CVD) cases are established when a foreign government provides assistance and subsidies, such as tax breaks to manufacturers that export goods to th..
Appraising Credibility, Reaching Conclusions & Writing the Investigative Report: Steps to Minimize Harassment Liability
Writing the investigative report actually begins from the very beginning of your investigation and continues throughout the process. This webinar will discuss the intricacies of writing the critical final report of your investigation that may be discoverable (all documents that must be provided to opposing counsel in case of a lawsuit) if an employee files a formal charge with the EEOC or your state’s human..
Are Your I-9's in Order?
To gain the Peace of Mind – knowing that all of your I-9’s are correct, you are using the most up to date form and no penalties will be issued in the event of an ICE audit. With over 17 years in business, the presenter has conducted hundreds of I-9 audits. Of those, one organization was 100% correct. That’s a very low percentage rate. Compliance is not difficult if you know what you are doing.Areas CoveredL..
Artificial Intelligence - What Every Lawyer Needs to Know
We will discuss what artificial intelligence is and why machine learning, a particular type of artificial intelligence, is changing the law we practice law. We will provide examples of how artificial intelligence is changing the law. We will then turn to various legal and ethical issues raised by the increased use of AI.Areas CoveredWhat is Artificial Intelligence?Machine Learning / Deep LearningAI Usage To..
Artificial Intelligence and the Law
In this practical webinar, you will learn about the latest developments in Artificial Intelligence and get a glimpse into the future, as additional legal tasks get automated.Upon course completion, you will be able to:Define “machine learning”Describe how machine learning is already being used by law firmsEvaluate how Artificial Intelligence is changing legal jobsConsider the ethical implications of Artific..
Asset Based Lending: Policy and Underwriting Guidance for Borrowing Base Lending on Receivables and Inventory
Asset-based lending (often referred to as “ABL”) is a form of commercial lending designed to finance safely the working capital needs of a borrower whose cash flow may not support debt repayment. Like other commercial loans, cash flow is the primary repayment source for an asset-based loan but with a stronger reliance on the company's assets as collateral and firmer control over the receipts of the collater..
Audit 2020: Keys to Becoming a Trusted Advisor
This webinar explores what it means to be trusted, how to give advice, and what it takes to be an advisor. We start by looking at behaviors and organizational challenges that auditors exhibit or face. From expected roles and responsibilities to tradition to regulator dependence, auditors must deal with several influences that seem to deter progress in this area.We then provide a profile of what a trusted ad..
Audit Trail Generation and Review
Computerized systems are used throughout the life sciences industry to support various regulated activities, which in turn generate many types of electronic records. These electronic records must be maintained according to regulatory requirements contained within FDA’s 21 CFR Part 11 for US jurisdictions and Eudralex Volume 4 Annex 11 for EU jurisdictions.One of the requirements for such compliance is the g..