Compliance Training Webinars for Regulated Industries

To document the clinical evaluation of a medical device and its output, a Clinical Evaluation Report or CER has to be compiled. The CER is an ongoing compilation of the generation, appraisal, and analysis of clinical data related to a device. It is one of the major components of the Technical Documentation File.

Ensure compliance in your social media marketing efforts with our "Social Media Compliance for Fair Lending" training. Learn what content is permissible and what's not to avoid potential regulatory issues. This course covers guidelines for posting on various social media platforms while adhering to fair lending laws. Gain insights into creating compliant content that promotes transparency and fairness in your lending practices. Equip your team with the knowledge needed to navigate the complexities of social media compliance, mitigate risks, and maintain regulatory adherence in your digital marketing strategies.

This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. Attend this webinar to know what happens in a recall and what are the strategies and operational procedures in a recall.

"Essentials of Successful Fraud Risk Management" is a session all about fraud. We begin by defining exactly what fraud looks like and provide a brief history of frauds impact to financial services.

What are the U.S. FDA's requirements for marketing and selling dietary supplements / nutraceuticals in the US, including their QMS per 21 CFR 111.

This session will review the current Department of Labor regulations as they apply to the white collar exemptions to the minimum wage and overtime requirement of the Fair Labor Standards Act (FLSA). The tests for exemption are the salary basis test, minimum salary requirement, and the duties tests. These tests have changed over the years and are complex and can be confusing. In addition, there are strict record keeping requirements and salary integrity requirements to prevent disqualification of the exemption. The webinar will also describe proposed changes to the rules and how employers can prepare for the changes.

Creating a safety culture in the workplace takes time, patience, and is often a multi-year process. This training program will examine how organizations need to transition from the existing zero injury workplace culture to a more safety oriented culture. In the process, it will examine the pros and cons behind each process and also offer best practices to determine whether you are doing it right.

This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.

The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.

What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.

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.

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 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.

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.