Compliance Training Webinars for Regulated Industries

PSURs are pharmacovigilance and device adverse events documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorization in the EU. The purpose is to harmonize and strengthen benefit-risk review of medical products across the European Economic Area.

This training is aimed at existing users of Microsoft Power BI who have mastered the basics and want to take their knowledge and learning to the next stage.

This webinar provides a basic overview of the stages of development and V&V of the basic categories of medical products, from R&D through Production, and the US FDA regulatory and documentation requirements at the various stages.

The FDA sites hundreds of companies each year for not adequately performing and documenting out of specification results. This course is designed to provide instruction on how to thoroughly document and investigate out of specification results using approaches which have been recommended by regulatory authorities.

In today's data-driven world, having a strong command of Power BI is essential, and understanding the Data Analysis Expressions (DAX) formula language is the key to unlocking the true potential of Power BI’s reporting capabilities.

This webinar is intended to provide guidance regarding the automotives industry use of AQP (Advanced Quality Planning) / APQP (Advanced Product Quality Planning) principles as adapted to CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.

The Bank Secrecy Act (BSA) is a US law that fights money laundering and other financial crimes. BSA requires businesses to keep records and file reports that are determined to have a high degree of usefulness in criminal, tax, and regulatory matters. Individuals and financial institutions who fail to comply with BSA requirements may face severe penalties and for more serious offenses, prison sentences.

Under a new California law- the first of its kind in the country- no later than July 1, 2024, California employers are required to establish, implement and maintain an effective workplace violence prevention plan and train their employees about the plan.

Employers and Human Resources professional must be readily familiar not only with the already-implemented requirements set forth by the PWFA, but also the brand-new regulations which support the PWFA so they can hit the ground running on June 19, 2024.

Whilst Pivot Tables offer valuable data summarization features, they also have several limitations. They struggle with handling large datasets, they lack the ability to combine data from multiple datasets and the built-in calculation functionality is very simplistic.

This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.

Are you confident that your employment, benefits, leaves, and I-9 files are in full compliance with state and federal compliance requirements? If you are pausing to answer this question or if it elicits feelings of dread, join us for an information-packed session that will reduce your risk for being assessed costly fines and being cited for potential violations. In this session, you will learn an organized way to assess your company’s needs for auditing HR files and staying ahead of ever-changing regulations. Special topics include organizing your HR recordkeeping system, auditing FMLA documents and procedures, and auditing I-9 forms and procedures.

Most employees insist they have privacy rights, especially at the workplace. But few know what those rights are. Likewise, not every employer or manager know what the employer’s privacy rights are or what their obligations are when it comes to respecting an employee’s privacy rights and what the penalties are for not doing so. And that was in a pre-Covid-19 world!

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.