Unconscious bias has been recognized as a form of discrimination and can therefore lead to lawsuits. This training program addresses the science of unconscious bias and lists the examples and types. The Instructor will discuss the implicit association test (IAT) and steps to minimize individual and organizational unconscious bias in hiring, promotions, and retention.
This 2-hr webinar on DEA Due Diligence will cover several recommendations to improve the Corporate Due Diligence when controlled substances and regulated chemicals are purchased by their customers and the steps that can be taken to detect and prevent the illicit use or diversion of any narcotic drug sold to customers.
In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System (QMS). Management requires suitable metrics presented in Management Review to understand, monitor, and improve the health of the Quality Management System. It is critical that management establishes a quality policy, quality objectives, and provides adequate resources. However, management often fails to realize the importance of their role with respect to quality. In this course, we will discuss how to improve awareness, focus, and a culture of quality. We will discuss how you can keep management aware and informed. We will discuss “red flags” or warning signs of problems.
The California Privacy Rights Act (CPRA), taking effect on January 1, 2023, will reset best practices for data privacy and protection of business to consumer online transactions. Preparing for CPRA is no small task. In addition to enabling substantial civil penalties and statutory damages, enactment of CPRA has propelled data privacy and protection as business risks directly into the boardroom. Join us for this webinar to accelerate your CPRA readiness, improve your risk management strategies, and prepare for fulfilling your CPRA obligations.
This program will review the compliance issues that most greatly impact your practice such as the 2-midnight rule, the NOTICE Act, HINNs, the important message from Medicare and others. The Joint Commission is now monitoring these issues when they have deemed status from Medicare, so your compliance is critical to a good Joint Commission survey outcome. This program will help you to identify where you may have compliance practice gaps as well as how to fix them.
This training program will discuss the concept and application of uncertainty of measurement (MU) as required by ISO/IEC Standard 17025:2005 for laboratory accreditation, from a practical microbiological perspective, using unambiguous language and useful examples.
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
This 60-minute webinar will help exporters understand International Commercial Terms, or INCOTERMs, published by the International Chamber of Commerce and how to select the correct one for their transactions.
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
The purpose of this webinar is to provide a high-level review of the Official Guidelines for Coding and Reporting FY2022 (General Guideline Changes and Chapter Specific Guidelines) to prepare for a new fiscal year of coding changes and meeting compliance, which begins on October 1, 2021. Also, we will present critical instruction on the new ICD-10-CM codes for FY2022 useful for medical practices and facilities for correct billing and reimbursement. There are 159 new codes, 25 deletions, and 27 changes! We'll go over some case studies to analyze and code with ICD-10-CM, which will help you improve your knowledge and skills.
This webinar will discuss the latest global medical device design controls requirements for software in a medical device (SiMD) and software as a medical device (SaMD). Each requirement pulled from U.S. and global standards and guidance (e.g. IEC 62304, IEC 82304, IMDRF SaMD Guidance, AAMI TIR45) will be explored to fashion a complete picture of activities, document content, and dependencies across a variety of lifecycle development models. The session will also include special topics such as evolving cybersecurity requirements, the relationship of software design controls to non-medical device applications, and proposed regulatory frameworks for AI/ML systems.
This training program will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful.
The meanings and regulatory requirements of the terms “verification” and “validation” are often confusing to engineers and even some regulatory professionals. FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards. The terms apply to design control, process control and others. This presentation will define and explain the differences (& similarities) in these terms and how they apply to regulated industries as well as the consequences of poor adherence.
Although the Family Medical leave Act (FMLA)was enacted 18 years (1993) ago the workplace still has problems complying with its requirements. Sometimes that required compliance is ignored because either the employer or the employee is not aware of their obligations, rights, or both. This webinar is designed to make that compliance easier to understand regardless of if it is a first line supervisor, manager or leave/benefits administrator or the employee.
Discrimination continues to be a problem in the workplace even with existing and developing regulations to train employees and managers against engaging in such behavior. The obligation to conduct a sound and thorough investigation by an appropriate investigator is mostly understood, but practitioners need to do that actual work. This course is designed to provide HR practitioners of all levels with a step-by-step process for conducting discrimination investigations in the work environment that will protect employees and the company as well.
ISO 14971:2019 is the definitive standard for risk management for medical devices and IVDs. The standard lays out a comprehensive approach to managing risks in the life sciences. The course will discuss practical approaches to complying with the standard.
This training will cover several recommendations to improve the hospital’s due diligence when administering and dispensing narcotic drugs in a hospital setting and what steps to take to detect and prevent the illicit use or diversion.
This course will cover validation essentials for medical device manufacturers. Attendees will learn about what processes needed to be validated and what steps you need to take to validate processes. You’ll learn the essentials of validation planning, protocol writing, and change management. We’ll cover the steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.