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..
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..
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..
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..
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 ..
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..
Many organizations are far from where they want and need to be with improving performance, and they apply intuition, rather than hard data, when making decisions. Enterprise performance management (EPM) is now viewed as the seamless integration of managerial methods such as strategy execution with a strategy map and its companion balanced scorecard (KPIs) and operational dashboards (PIs); enterprise risk ma..
You will learn all about how to start the analysis process, how the FASB and SEC operate together and where you can find audited financial statements, and how to retrieve them. We will cover the auditor’s opinions and what they mean. We will discuss the objectives of analysis management, learn tools and techniques such as common sizing financial statements and trend analysis. We will cover the five categori..
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..
This webinar will provide an in-depth understanding of the Federal False Claims Act, Federal Anti-Kickback, and Stark laws, and discuss how marketing activities can trigger either or both.This program will review the Federal False Claims Act and its various elements. It will examine what it covers and how it works, what is required to prove a false claim, who can bring an action under the Act, its damages, ..
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..
Highlights will include an intro to what to do on an audit, how to be ready, what is fair game for review, critical documents required, vital Food Safety Plan, focus on hazards or Hazard Analysis Risk Preventative Controls (HARPC), Supply chain Preventative Controls and importance of managing the audit, sampling, swabbing, warnings and wrap up meeting.Key FSMA Audit takeaway points would include: New FSMA r..
FDA implemented the new Food Safety Modernization Act (FSMA), including the hazard analysis and risk-based preventive in 2016 to help industry manage potential hazards in producing safe food products. FSMA places primary responsibility on the owners and operators of food facilities to identify and control hazard risks, and intentionally grants facilities considerable flexibility in desig..
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..