Healthcare

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a particular methodology to correct, prevent and avoid reoccurrence of these matters.

Professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs, reduced staffing, and diminishing resources. Many workers are putting in longer hours and for less pay. From working overtime to simply burning the midnight oil catching up on paperwork, work industry puts a great deal of stress and fatigue on the average worker and their relationships, including family. Many professionals bear witness to workplace challenges that range from troublesome to traumatic. As a result, high stress and burnout are major hazards of any profession. This seminar focuses on understanding each of these challenges. In addition to defining and comparing these conditions, specific triggers will be explored. Participants will gain awareness of key signs and symptoms of stress and burnout, while learning how to manage stressors and their consequences.

Credit Risk Management is the function that ensures the organization is balancing its risk appetite with its risk tolerance to attain the organization’s desired credit risk objectives. This course provides guidance in how to implement and maintain the desired level of credit risk management with practical tools and techniques. Both the market and the regulatory agencies expect credit risk management to reflect the bank’s credit culture, so the class also offers direction on how to identify the organization’s credit culture and to reposition it to support the desired credit risk culture and management

In this program, we will review the physician anti-referral laws (Stark I and II), provide an in-depth discussion of physician employment contracting, review the relevant Stark exceptions and discuss how physician compensation models can be in compliance with the Stark prohibitions.

Overview: The Webinar will focus on the importance of ensuring that the validation of an FDA-regulated computer system will meet compliance guidelines.

Sponsors or consultants auditing labs on behalf of a pharmaceutical or biopharmaceutical company need strong tools for preparing and conducting audits.

Overview: The outbreak of coronavirus disease (COVID-19), first in the People's Republic of China (PRC or China), and now globally, including in the United States, is drawing attention to the ways in which the United States and other economies depend on critical manufacturing and global value chains that rely on production based in in the PRC and other countries. Congress is particularly concerned about these dependencies and has passed legislation to better understand and address them. An area of particular concern to Congress in the current environment is U.S. shortages of medical supplies - including personal protective equipment (PPE) and pharmaceuticals -as the United States steps up efforts to contain COVID-19 with limited domestic stockpiles and insufficient U.S. industrial capacity. PPE, antibiotics, and active pharmaceutical ingredients have led to shortages of critical medical supplies in the United States.

This webinar addresses the importance of method development in successfully overcoming difficult validations. Specific topics are unique challenges for cell-based methods, use of DOE to define method parameters, and creating unambiguous methods.

Overview: This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors. Why you should Attend: Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. Procedures play a vital role in human reliability.

Overview: The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based?

Overview: Good documentation practice (commonly abbreviated GDP, recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. In a pharmaceutical or medical device environment documentation needs to meet certain requirements to ensure product quality and product safety. Documentation provides both: Information on when, where, who, why and how to complete tasks, and Evidence proving that the tasks have been completed as they should be

This seminar provides Professionals working in this area with: A thorough understanding of the complexities involved Covers all the relevant regulations and guidelines Gives real life examples of how to register and maintain various types of combination products Interfaces: Change Management and LCM Compliant safety reporting for combination products Documentation requirements and interfacing

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation. They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA.

Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees. Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity.

This 6-hour seminar will cover the latest SAMHSA and HIPAA updates which were released in January 2018 and December of 2017 respectively, and also cover multiple scenarios and FAQ’s relating to Substance Abuse Records, Mental Health Records, Alcohol Abuse Records, and the proper ways to secure this information and/or release this information.

One of our most popular webinars, continuously updated with the latest U.S. FDA and Eurpean Union requirements. Now expanded to a six-hour format. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). In order to sell globally, the EU's CE-marking documentation is a requirement - the Technical FiIe or Design Dossier under the old MDD, and the Technical Documentation requirements of the new MDR. Currently they serve differnt purposes, support different goals, but the TD File is moving in the direction of the DHF. And the DHF is adapting to some of the features of the TDFile. And how / where do the DMR and DHR fit? Being aware of the similarities and differences in the files and their individual documents can further concurrent development and/or updates to both.

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies.

This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated with the perspectives of Instrument Control, System Suitability Test (SST), Analytical Methods Validation and ensuring Data Integrity for Regulatory Compliance.

Professionals are under more stress than ever evidenced by increases in demand for better services that are more efficient and thorough, higher costs, reduced staffing, and diminishing resources. Many workers are putting in longer hours and for less pay. From working overtime to simply burning the midnight oil catching up on paperwork, work industry puts a great deal of stress and fatigue on the average worker and their relationships, including family. Many professionals bear witness to workplace challenges that range from troublesome to traumatic. As a result, high stress and burnout are major hazards of any profession.

In this webinar, you will learn how to take your raw data, and create meaningful reports using the powerful tools in Microsoft Excel. As a business owner or manager, you have mounds and mounds of raw data transactions, and it is a monumental task to make any sense out of that data. After this webinar, you will be able to take tons of Excel data, and quickly and easily get summary reports and charts. We will start off with the basics, then, we will add sorts, filters, subtotals, grand totals, and formulas to create a great reports that summarize your data into meaningful information that will allow you to run and manage your business better.