Compliance Training Webinars for Regulated Industries

Companies engaged in the conduct of human clinical trials must adhere to specific government regulatory requirements. Certain documents, content and images related to a clinical trial must be stored and maintained, and depending on the regulatory jurisdiction, this body of information may be stored in a trial master file (TMF). All of the data and documents supporting the planning, conduct and evaluation of a clinical trial must be of the highest integrity, which must be maintained through their entire life cycle. Computer System Validation will be discussed as a key methodology for meeting all of these requirements and assuring data/document integrity.

This NACHA Operating Rules training session will provide the details on the proposed changes that potentially may be happening in the future. How it is going to impact you and what can you do about it.

A pre-approval inspection (PAI) is performed to provide the Food and Drug Administration (FDA) assurances that a manufacturing site named in a drug application is capable of consistently manufacturing a safe drug product, and that the submitted data is accurate and complete against what was filed in their application. This training will provide guidance on when the FDA performs pre-approval inspections. It will describe how to prepare for a PAI, and the outcomes of pre-approval inspections.

Third Party Risk Management is all about managing service providers. For several years, businesses have been increasing reliance on third parties. While this reliance has many upsides, there are risks that should be recognized and managed. This session highlights those risks and provides alternatives to best manage them.

The U.S. FDA has several requirement for the labeling of medical products. The key requirements are in 21 CFR 801.

New ISO standards, including ISO 9001, will include additional requirements related to climate change. These fortunately do not involve carbon neutrality goals, but do require organizations to consider climate change and also potential requirements of relevant interested parties.

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

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!