Compliance Training Webinars for Regulated Industries

This Webinar will highlight the requirements of ISO 17025 and ISO 34 and explain the preparation, testing of certified reference materials along with assessment of suppliers of reference materials.

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment to improve performance. Thus, the field version of the software is no longer the validated approved version.

What are the rules regarding how you may contact a debtor? They are so complex and confusing! There are many issues involved, such as what questions you may and may not ask someone other than the debtor and restrictions on what you can leave in voicemail or send in an email, and the best ways to handle suspected deadbeats. What is the best practice for postings to open accounts when the debtor may file bankruptcy? Did you know that medical collections must be treated with more care than consumer collections? Learn the answers to all of these issues and your own questions when you attend this detailed presentation of the FDCPA.

Statistical Process Control charts have been called the Voice of the Process. Progressive manufacturers utilize control charts to “listen” to their processes so that potentially harmful changes will be quickly detected and rectified.

However, not all SPC programs deliver to their highest capability as there are many elements to get right to achieve maximum utility. Highly effective SPC programs combine technical competencies, such as using an appropriate chart and sample size for the application, with effective management techniques such as enabling operator buy-in and involvement. This webinar identifies and describes ten keys that unleash the power of SPC.

The audience will take away a basic understanding of what the OSHA Recordkeeping Requirements are and learn to navigate the complexities in filling out the 2024 OSHA Recordkeeping Forms.

New and Realistic Lean Manufacturing can be a key to company success, by incorporating basic lean principles, while addressing FDA / CGMP requirements.

We will discuss the importance of complying with FDA requirements for validation of systems using technologies that have been emerging for the past couple of decades. While FDA is planning to overhaul their own infrastructure to gain efficiencies, they are also encouraging industry to take advantage of newer technology and systems. These include cloud-based systems, Software-as-a-Service (SaaS), artificial intelligence, and others.

We’ll talk about taking a risk-based approach to validation, and how to implement newer capabilities such as electronic records and electronic signatures. We’ll also cover the importance of meeting data integrity compliance.

This biotech training will provide valuable assistance to all regulated companies (Pharma, OTC etc) that manufacture non-sterile products.

States are tense. They need more revenue. Millions of dollars of internet sales occur daily without tax. The states want their money. In just 90 minutes, learn the different ways your company triggers nexus on itself and what it must do to comply with state regs.

This webinar will provide an in-depth review of enforcement actions taken by the HHS OIG over the previous two months. We will also briefly review the Anti-Kickback Statute (“AKS”), discuss any new safe harbors, and OIG Advisory Opinions that have been issued.

This Quality inspection training will teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner.

Fundamental requirements for process validation in both FDA QSR and ISO 13485. Learn when a process should be validated, the basic components of a process validation (IQ, OQ, and PQ) and how to write protocols and reports.

This webinar will provide valuable guidance to regulated companies in development and implementation of Design Control Planning and Techniques for new or heavily changed product development under 21 CFR 820.30, "Design Control", and ISO 13485 7.3. Also regulatory compliance proof of "progress against plan", and other activities requiring a planned documented rationale. It should be an important part of a company's IP (Intellectual Property).

In this informative webinar, you will learn how to properly account for and report expense reimbursements and facilities provided to employees in compliance with IRS requirements. Discussion includes work from home expense reimbursement.

This 1-hour webinar will provide high-level overview of the UK RoHS and REACH obligations effective January 1, 2024 due to Brexit. Key developments and dates will be discussed with an emphasis on the new regulations and systems implemented by the UK.

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.

In today's rapidly evolving scientific landscape, the 90-minute webinar titled "Human Error and Documentation Practices in Good Laboratory Practices (GLP)" offers an essential exploration of the critical role that accurate and complete documentation plays in maintaining the integrity of research processes. Delving into the heart of Good Laboratory Practices (GLP), this enlightening session uncovers the intricate relationship between meticulous documentation and the reliability of scientific findings. Over the course of the webinar, attendees will gain a comprehensive understanding of the multifaceted challenges posed by human errors within laboratory environments. With real-world examples, the webinar illustrates the potential consequences of inadequate documentation, underscoring the significance of precise record-keeping in safeguarding data integrity, research reproducibility, and regulatory compliance. Attendees will also glean valuable insights into common documentation errors and pitfalls, as well as invaluable strategies for bolstering documentation practices. From proactive measures and standardized procedures to fostering a culture of clarity and collaboration, participants will leave equipped with the tools to elevate their documentation practices and contribute to the overall credibility of their scientific endeavors.

Employers are seeing more mental health issues in their workforce than ever before. Long COVID has enhanced mental health concerns even more. Each year 1 in 5 adults is stricken with a mental illness (National Institute of Mental health), making mental illness an everyday reality for many of your employees. Yet only 1 in 3 people seek help with their illness. The ADA, HIPPA, FMLA and most states’ human/civil rights department dictate how employers deal with employees with mental health problems and could charge employers with civil rights liability. Privacy laws create challenges for employers to determine how serious a situation is and whether an employee poses a danger (though those with a mental illness pose no more risk of violence than those without a mental illness). Two thirds of employees would take a pay cut for a job that supports mental health – do you? As a manager, what can you do to better recognize and take care of your employees’ mental health? Seventy percent of employees could do more to support their employees’ mental health according to the Society of Human Rights Management (SHRM, February 15, 2023).