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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..
Audit2020: Evolving the Internal Audit Process
The internal audit profession is very similar to other professions; very resistant to change. When one of our profession’s main goals is to promote efficiency and effectiveness, we have to be more adept at adjusting and being open-minded to change. Audit2020 is a course that takes an in-depth look at the accepted practices inherent in internal audit and critically analyses each piece, identifying ways to en..
Auditing Basics and Fundamentals for Medical Devices and Drugs
Internal audits are not just an important requirement for effective corporate governance – they are intended to show compliance with various domestic and international laws and regulations. Audits are also a fundamental tool of risk management. The auditor assures alignment with prescribed practices and is at the front line in evaluating control systems, testing, measurement and more. Auditors asses the acc..
Auditing Business Continuity Plans According to ISO 22301
Successful business continuity planningInvolves the entire organization Requires clear and consistent communication Encompasses how employees will communicate, where they will go, and how they will keep doing their jobsPrepares the organization for disruptive eventsWhy is BCP Important? 61% of companies surveyed had to invoke their BCP 43% had to invoke it more than onceKey Causes: Natural Disaster, Power O..
Auditing Quality Suppliers and Vendors
The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking whether these organizations have implemented what they have stated in written procedures and whether their people are doing what the organizations procedures state they will do.Learning Obj..
Auditor Responsibility Re: Fraud
This webinar focuses on fraud in the corporate environment. It reiterates some of the authoritative CPA literature related to fraud. It is, however, equally important to non-CPAs (e.g. internal auditors, corporate departmental managers, senior management, board members). It provides a basic understanding of fraud-related definitions and requirements. In particular, it separates the fraud discussion between:..