Compliance Training Webinars for Regulated Industries

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.

Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

An import compliance manual is a very important document for any company. It demonstrates the company’s commitment and understanding of the applicable import regulations. Further, it helps all the relevant employees understand their roles and responsibilities to create a compliance culture, minimizing the risk of unintentional import violations and avoidable import penalties.

The COVID-19 pandemic has presented challenging wage and hour questions for employers. The federal Fair Labor Standards Act (FLSA)—and corresponding state wage and hour laws are not on hold during the pandemic. In addition to FLSA obligations, decisions regarding wage and hour could trigger nondiscrimination laws, health and safety laws, leave and accommodation laws, and state-specific laws. It also clarifies some common questions about how to handle pay for workers when they can’t physically come to work.

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.

The goal of pharmaceutical development is to design a manufacturing process that can produce a drug product to a consistently high quality. This webinar sets out regulatory expectations for pharmaceutical development, taking account of the risk-based approach set out in ICH guidance documents (Q8, Q9, Q10 and draft Q12). It covers some examples of problems encountered during drug development.

It's easy to become a victim of the "To-Do" list, crisis management, and reacting to the latest fire. Unfortunately, that approach seldom leads to sustainable success. Focus on driving your daily action through the power of your vision and mission, plan strategically, and focus on results to get the progress your organization demands. In 2020 that means staying more concerned with your team members’ wellbeing and their needs.

An export compliance manual is a very important document for any company. It demonstrates the company’s commitment and understanding of the applicable export regulations. Further, it helps all the relevant employees understand their roles and responsibilities to create a compliance culture, minimizing the risk of unintentional export violations and avoidable import penalties.