Compliance Training Webinars for Regulated Industries

Using a mock scenario involving an employee’s complaint of harassment against her supervisor, this webinar will walk through the stages of planning and performing a workplace investigation. While going through these stages, we will discuss best practices in handling investigations such as how to address requests for confidentiality, how to prepare for questioning key witnesses, and how to document the investigation. This webinar will also touch on key practices to minimize the risk of retaliation against the employee or witnesses.

This webinar will present approaches to instrument calibration that are used by FBI, FDA and EPA in forensic and environmental analysis. It will emphasize the importance of calibration in obtaining accurate results in analysis of trace evidence, toxicological specimens and environmental samples.

This webinar will discuss ways to value your private company using easy to implement methods and tools that don’t require advanced training or resources. We will be covering areas and measures that will be key to raising capital among shareholders and other financiers.

This webinar discusses the main areas of impact that documentation can have on a business to ensure that all members of the management team understand the proper methods, the results that can be achieved, and the costly mistakes that can be prevented with good documentation practices.

This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.

MIPS Data Validation Audits started in June of 2019. The MIPS has a number of vulnerabilities related to its reporting requirements and associated complexities. This presentation will address potential vulnerabilities and provide specific recommendations that will help protect your practice from a negative audit.

This training program will discuss the critical steps of the 360 degree feedback process, keys to identifying an effective 360 degree feedback instrument, important information regarding the selection of raters, insights into effective debriefing and coaching after debriefing can help an individual make necessary and suggested behavior changes which positively improve performance and perception.

The emerging medical foods market in the United States is $1.3 billion annually with strong growth potential. As a distinct, FDA-regulated category, medical foods are gaining more widespread acceptance. However, they remain poorly understood by patients, pharmacists and physicians. This webinar will describe the regulatory pathway for approval, the definition of a medical food, examples of medical foods, and product development opportunities.

An SLA - which can be a legally binding formal or informal contract between two parties, must comply with operating norms, which describe how the process is governed, managed, and controlled. In this webinar we will provide you with critical information on SLA process.

This webinar will describe the basic principles of drug metabolism, with specific emphasis on the various metabolic pathways and mechanisms that commonly reduce drug exposure. With greater understanding of these mechanisms, drug hunters have a higher probability of designing drug candidates that are less susceptible to metabolic clearance and elimination. The webinar will also highlight drug metabolism issues such as reactive metabolites and drug-drug interactions (DDIs) due to inhibition or activation of cytochrome P450 (CYP) enzymes. Common mitigation strategies for metabolism-related issues will also be reviewed.

This webinar will provide you a thorough background into the FDA regulatory and EU control issue related to the specific device required to provide expert opinions.

This webinar will discuss the basics of product registration in Mexico, Brazil and Argentina such as Registration Timelines, documentation requirements and governmental processes.

In this webinar, get questions relating to the availability of necessary adaptive technologies and modifications in traditional instructional methods which allow the student with a disability to benefit from an available technology such as Kurzweil reading, Dragon text to speech, etc.

This banking regulatory compliance training will help you understand operational risks in your organization and their impact on an organization’s efficiency. By attending this webinar you will learn the tools and techniques for managing the most important risks.

This webinar will help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. You will gain an understanding of the regulations and learn to translate them into an efficient and effective process for purchasing/ supplier control. You will learn about the essential elements of purchasing control and how to translate them into your procedures, prevent quality and compliance problems by having a strong system for Purchasing Controls. We’ll discuss the process steps for purchasing control and how it relates to other parts of your QMS including receiving and acceptance activities.

This webinar will discuss ways to effectively and efficiently deal with regulators, whether it be from an audit or other interaction. Regulators speak their own language and understanding this is imperative to building relationships and passing regulatory scrutiny.

The FDA’s emerging approach to medical software product regulation has important ramifications for patients, healthcare providers and insurers as well as product developers. So, it is critically important for companies throughout the life sciences and healthcare industries that utilize software in its products to understand the important challenges and opportunities presented by this major policy shift. This webinar will provide understanding.

This four day webinar series (each day 3 hrs) will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.

This webinar will provide a detailed overview of proven strategies that maybe employed to ensure that hospital goals are aligned with medical practice. This is key to delivering high-quality coordinated care to produce Quality Patient Outcomes and Cost-Effectiveness. There will be special focus on the Utilization Review Committee (URC) as a CoP.

Premarket Approvals Premarket approval (PMA) are required by The Food and Drug Administration is the regulatory protocol presently used to evaluate the safety and effectiveness of Class III medical devices, e.g., an implantable cardioverter defibrillator (ICD). This webinar will help you understand the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature. The information when applied is most effective in reducing potential adverse events.