Compliance Training Webinars for Regulated Industries

An audit function should be thought of and managed as an independent business, including stakeholder analysis and feedback, setting objectives, developing necessary processes for managing resources and risks, measuring and improving performance, and even marketing to potential customers. This webinar covers topics specifically related to the audit system. How professional judgment and intent need consideration, auditing risks, and how entity life-cycles can affect audits are vital areas addressed during the webinar.

This program will follow the risk management process described by the International Organization for Standardization (ISO), which sees risk management as a strategic and enterprise challenge. Like strategic planning and management, risk management is cyclical and must constantly be reassessed, evaluated against changing conditions and improved.

COVID-19 is making a comeback in the last part of 2020, primarily because people are dropping their guard against it the way they did in 1918. This threatens the health and safety of stakeholders (workers and customers) as well as continuity of business operations. Extensive guidance is however available on how to protect stakeholders and keep businesses in operation.

This new 2020 HR Metrics session reviews the utilization of HR metrics and analytics as a core competency, reviews the role HR metrics play in helping the organization make critical business decisions, describes the calculation of employment practices liability risk exposure, and provides a listing of some of the more widely used HR metrics.

This webinar will cover creating of a value-added internal auditing program that is compliant to FDA cGMP/ Quality System Regulation and ISO 13485. It will include how to set up and manage the auditing system as well as how to conduct an internal audit and document the results and any nonconformities. It will discuss the value of a good internal auditing program.

Learn how to analyze the numbers and use this intel to juice up virtually every facet of your organization’s operations from sales and marketing, to finance, HR, and customer service. Use our proven model to quickly assess the financial condition and results of operations of any business using trend and ratio analysis. Join C-suites and business analysts from around the country and empower your team to maximize the benefit from your crystal clear understanding of the numbers. If you are interested in understanding the numbers and have basic grasp of excel, you will enjoy and benefit from this course.

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

FDA regulated industries can prophet by understanding the regulatory power of FDA and incorporating this knowledge into their daily routine. Time and resources spent preparing for the inevitable inspection will pay back proportionately. By doing your homework and putting simple principles to work you can minimize the negative effects of FDA’s power and put everyone in your organization at ease. By understanding the risks inherent in your products, you can develop a quality system that will align your operation with FDA’s expectations. Why live in fear when you can rest at night knowing you are ready?

California statutes pertaining to meal and rest periods for non-exempt employees is one of the more confusing topics in today’s business environment. This course is designed to provide you with a practical foundation for understanding the law. It includes guidelines for how to properly create and administer your own meal and rest period policy. Or, if your company already has its own policy, then this information can help you review your existing policy as well as the procedures and practices in “real life” daily operations.

In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions

Attend this webinar to understand hospital utilization management despite demanding payers doing everything they can to deny payment through denial of medical necessity. Learn about the best model of case management, denial management, and best practices in clinical reviews.

The rough breakdown of medical device failures is 60% residing with the product specification and only 30% of the errors in the components themselves. This rough breakdown indicates that most of the problems are referred to as management errors – caused by faulty systems, processes, and conditions. A failure of procedures and execution. In other words, management failure. In this webinar, learn the strategies to prevent such medical device recalls.

FDA requires that all computer systems used to produce, manage and report data for “GxP” (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will help you understand the FDA’s current thinking on computer systems that are validated and subject to inspection and audit.

After attending this training program, attendees will have a better understanding of the issues concerning the pricing of contractor delay damages. Contractors will gain knowledge about the various methods of calculating extended field office overhead costs. Owners will learn some contractual methods for predetermining this element of delay costs in order to prevent the need for end of the job audits or disputes over such costs.

This equipment qualification webinar will discuss the requirements for IQ, OQ, and PQ protocols. It will train about the various components of each protocol, Proper language for documenting qualification testing including how to Collect data, conduct tests, and obtaining all necessary documents.

Attend this course to prepare for and understand what will happen during a Drug Manufacturing Inspection for Surveillance Inspections. It will explain the FDA criteria to perform a For Cause Inspection.

This webinar training will explain the role of HR professionals and managers in implementing discrimination-free dress code to ensure all job candidates and employees are treated fairly and equitably. Dress codes are receiving a fair amount of attention in the courts these days with number of precedent setting lawsuits dealing with dress codes’ requirements. The instructor will explain how your current dress code can discriminate against potential and current employees based on their gender, religion, and race, to name a few and lead to lawsuits.

You need to protect your information technology assets and information against unauthorized internal or external access and cyber-attacks. Data destruction, alteration, unavailability or breach of confidentiality are the consequences of such attacks. A primary step toward inventorying, assessing, and addressing cyber risks that threaten your organization is to develop and maintain a cyber risk management program as part of your enterprise risk management framework. This presentation will help in developing your organization's risk profile and decide the action plans to mitigate those risks.

In a 24/7, rapidly changing, always on, "do more with less" world, not surprisingly, individual stress and interpersonal tension can influence the organizational climate, communication, and coordination. The challenge becomes sustaining resilience and morale while forging cooperative and productive working relationships and partnerships.

This webinar will provide a comprehensive understanding of the provisions of the FLSA. You will learn the proper calculation of overtime pay, gain an understanding of what is considered hours worked, what to do when state and federal laws differ, when employees must be compensated for training, travel time, meal breaks, and on-call status.