When FDA shows up at your door to announce an inspection, what do you think is going to happen? More importantly, what are you going to do?An ex-FDA investigator will conduct this webinar to share an “insider’s” perspective about inspections. What’s important, what’s not, and what is a fatal mistake on the part of a firm. Firms need an established FDA inspection protocol that describes what happens during a..
Manufacturing Quality Agreements- Qualifying Suppliers and Managing Quality in FDA-Regulated Industries
Quality agreements are an integral part of outsourced GMP manufacturing and testing. They define the framework for quality expectations between you and your vendors and the responsibilities necessary to demonstrate drug quality, safety, and efficacy. In 2016, the FDA issued dozens of 483 observations relating to topics governed by the quality agreement system. Furthermore, in November 2016, the FDA finalize..
This webinar will be the best guide to issue spotting potential problems a non-for-profit may come across and how to appropriately handle them. The IRS allows certain organizations to not pay taxes as long as they meet strict guidelines. Violating these guidelines can have strict and harsh ramifications for the non-for-profit and the people in charge of the organization.This webinar will help to first prope..
Human nature does not change but our understanding of human nature does change. Every manager must become adept and getting the best performance out of every employee. Today that means adapting the traditional management and leadership categories to the current situation. For example, employees are assigned specific tasks to perform and goals to meet. Collaborative spend time with each employee and then wit..
Capital Adequacy and Stress Testing: Understanding the CCAR (Federal Reserve) and DFAST (OCC) Programs
Banks and Credit Unions are subject to programs of the Federal Reserve, the Office of the Comptroller of the Currency (OCC) and the National Credit Union Administration (NCUA), which test whether each Bank or Credit Union has sufficient capital to navigate successfully through adverse future economic scenarios. The required analysis involves estimating the losses the Bank or Credit Union will incur in a ran..
One of the most common complaints we hear from supervisors and managers is that people who work for them won't take responsibility for going the extra mile and doing what is necessary to get their jobs done right.“It’s “It’s not my fault.” “It’s not my job.” “I didn’t know.”Excuses. We’ve heard them all. Wouldn’t you love to have all your employees see what needs to be done, do what needs to be done and acc..
Mr.Shapiro shall present the basic principles and practices of Risk Management Approach and Risk Analysis. Presentation best practice tools to manage risk analysis and risk management. Present some common errors when dealing with risk management. Present the new additions and changes to the new standard. Risk approach has become a mandatory practice during the Product Realization of Medical Devices. This pr..
All great leaders have common amongst themselves certain ingrained habits of behavior that help them separate from the pack and achieve at the highest levels. These habits are learned and developed in a very deliberate way. We will show you how. Learning ObjectivesWhat does a great leader look like and act like?How do you live with integrity as a leader?The magic of self-control, growth and caringWhat about..
Collection prioritization guides the collection process by specifying in what order customers are contacted to secure payment of open receivables (i.e., AR). This applies to both B2B and B2C receivables. It focuses the scarce collection resources in your organization to minimize AR delinquency, risk of bad debt loss, and cost of AR management while maximizing cash flow from AR.Objectives of Today’s Discussi..
Credit memoranda serve as the primary means of communication in the banking domain. It covers three functions: providing details on customer relation status, record actions, and thoughts, and recommend or support action. An effective memorandum is not about what you say, but how you say it, for commanding attention.Join industry expert Dev Strischek as he helps you develop your skills in writing an effectiv..
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..
This 90-minute content-packed session begins with 3 techniques to get rid of hundreds of unneeded email messages. We’ll introduce search techniques to help you uncover messages that you will be comfortable deleting right away. You’ll learn how to use grouping and sorting to get rid of dozens of messages in a single operation. Then we move on tools and strategies to stay out of trouble. From one-click soluti..
How Do They Work Together—Or Not? : The Complexity & Interplay Among the ADAAA, FMLA, and Worker’s Comp
Challenges - It’s confusing, isn’t it? How are we supposed to keep it all straight when there are times when the legal requirements of both the Family Medical Leave Act (FMLA) and the American Disabilities Act Amendment Act (ADAAA) are similar, yet at other times one law contradicts another? We find that we can’t comply with both laws at the same time, so which one takes precedence over the other? And where..
This webinar will cover the basics of Form 1099-MISC and will help a business stay in compliance with the law. We will discuss what payments are reportable, who needs to be sent a 1099-MISC, and how to send a 1099-MISC. We will discuss penalties and how to get out of penalties, and how to tell the difference between a contractor (who gets a Form 1099-MISC) and an employee (who gets a Form W-2). We will also..
This Bank Secrecy Act (BSA) training program will explain how to train your frontline staff to ask BSA questions. It will cover Currency Transaction Reports (CTR), Monetary Instrument Log, and Suspicious Activity Reports (SAR) scenarios and questions, and much more.A financial institution’s front line staff is the staff who usually has the most contact with customers and as such this staff has the opportuni..