Compliance Training Webinars for Regulated Industries

Sexual harassment 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. This course is designed to provide HR practitioners of all levels with a step-by-step process for conducting sexual harassment investigations in the work environment that will protect employees and the company as well.

Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the essentials of design controls for medical devices.

Developing a QMS is a prerequisite for getting accredited. ISO/IEC 17020 sets out general criteria for the operation of various types of bodies performing inspection. ISO/IEC 17025 is the international standard for the General requirements for the competence of testing and calibration laboratories. Which is the right standard for you?

Strategically, tactically, and operationally sustaining information technology (IT) confidentiality translates into maintaining assigned information asset privacy levels. Organizations have failed in securing the privacy of personally identifiable information. In response, this presentation addresses information security issues regarding ISO/IEC 27701: 2019 standard integration considering the current organizational privacy protection practices.

Tests of superiority, using null hypothesis statistical testing (NHST) are the norm in most research settings. However, there are situations where superiority of a treatment to a control is not needed, and sometimes it is not ethical to do so. For example, a researcher may be interested not in superiority, but instead, would like to compare the efficacy of a newer drug with a working treatment (an active control). In this webinar, Elaine Eisenbeisz will introduce types of statistical tests that can demonstrate that two treatments are ‘similar’ to each other in terms of their clinical effectiveness.

For FY2022 there are 191 new PCS codes! Hospital Coding and CDI professionals need to review key aspects to the Official Guideline changes. Understanding the FY2022 new ICD-10-PCS codes changes and the clinical meaning including new devices and new technology are vital for coding accuracy. Coding personnel must learn coding rules, as well as what documentation is required to submit PCS codes and how they affect the ICD-10-PCS tables.

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.

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.

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.

HCC education to coding staff and providers can help them understand the necessary documentation specificity and improve audit results. It’s important to know the Documentation and Coding tips that will help you know when to query the provider and improve accuracy. Which provider specialties are acceptable under the CMS-HCC model to document and submit ICD-10-CM codes? Information will be shared on CMS RADV and OIG audits and compliance scrutiny so that your office/department can be proactive.

HR professionals frequently supervise, manage and/or analyze and report many types of HR data. This overflow of personnel data ranges from employee timesheets to payroll records to the department, divisional and company-wide employee information including hiring date, salary, position, employee class, department, division, employee evaluation ratings, and much more. This 90-minutes of concise, focused Excel training designed specifically for HR professionals can simplify these tasks for you.

This webinar provides overview of common problems encountered in payroll and methods for prevention, mitigation and resolution. The discussion will include when use of specific forms may be required, such as Form 941-X, Adjusted Employer's Quarterly Federal Tax Return or Claim for Refund and Form W-2C, Corrected Wage and Tax Statement. Special procedures related to fringe benefit withholding, deceased employee wages and misclassified employees will be covered.

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.

Onboarding new employees in a pharmaceutical company, which is required by law to follow the regulations governing current Good Manufacturing Practices (cGMP), creates additional complexities besides the Human Resources element. As government regulatory agencies have expectations regarding the process of qualifying employees to perform their job duties, it is essential to become familiar with these expectations and the implications that they have for the company’s training plan. In addition, companies have been penalized for failure to follow established regulations, which can create issues that can impede production, damage a company’s reputation, or ultimately lead to recalling or discontinuing product. Still, the process is not straightforward, and questions inevitably arise regarding the application of the regulations. This course will address the issues that accompany onboarding new or transferred employees and enable you to navigate them successfully.

Compliance with international standard ISO 13485:2016 is mandatory for all medical devices placed in most of the main markets word wide. It is of strategic importance for any medical device manufacturer to understand and effectively apply the ISO 13485:2016 requirements to access these critical markets.

Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al

As Compliance Officers, we need to be prepared and be able to communicate with those who will be impacted by the upcoming changes. There are several changes coming our way in 2025.

Counterfeit drugs present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of them.

This training on Software Development Standard IEC 62304 will provide you key insights on how to understand IEC 62304, and how to use the standard to help you uncover software related GMP violations.

This webinar will help participants understand how change impacts people, and why people resist change. You will also learn five powerful strategies for minimizing resistance and increasing engagement, and how to create and sustain a culture of change in their organization. This webinar will help organizations and leaders to be more strategic and successful with change efforts. The strategies included in the webinar will also benefit the people most impacted by change.