Compliance Training Webinars for Regulated Industries

Attend this course to prepare for and understand what will happen during a Drug Manufacturing Inspection for Surveillance Inspections. It will explain the FDA criteria to perform a For Cause Inspection.

This webinar training will explain the role of HR professionals and managers in implementing discrimination-free dress code to ensure all job candidates and employees are treated fairly and equitably. Dress codes are receiving a fair amount of attention in the courts these days with number of precedent setting lawsuits dealing with dress codes’ requirements. The instructor will explain how your current dress code can discriminate against potential and current employees based on their gender, religion, and race, to name a few and lead to lawsuits.

You need to protect your information technology assets and information against unauthorized internal or external access and cyber-attacks. Data destruction, alteration, unavailability or breach of confidentiality are the consequences of such attacks. A primary step toward inventorying, assessing, and addressing cyber risks that threaten your organization is to develop and maintain a cyber risk management program as part of your enterprise risk management framework. This presentation will help in developing your organization's risk profile and decide the action plans to mitigate those risks.

In a 24/7, rapidly changing, always on, "do more with less" world, not surprisingly, individual stress and interpersonal tension can influence the organizational climate, communication, and coordination. The challenge becomes sustaining resilience and morale while forging cooperative and productive working relationships and partnerships.

This webinar will provide a comprehensive understanding of the provisions of the FLSA. You will learn the proper calculation of overtime pay, gain an understanding of what is considered hours worked, what to do when state and federal laws differ, when employees must be compensated for training, travel time, meal breaks, and on-call status.

Attend this course to learn the rationale, strategies and flow on how to plan for an FDA inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.

An import compliance manual is a very important document for any company. It demonstrates the company’s commitment and understanding of the applicable import regulations. Further, it helps all the relevant employees understand their roles and responsibilities to create a compliance culture, minimizing the risk of unintentional import violations and avoidable import penalties.

The COVID-19 pandemic has presented challenging wage and hour questions for employers. The federal Fair Labor Standards Act (FLSA)—and corresponding state wage and hour laws are not on hold during the pandemic. In addition to FLSA obligations, decisions regarding wage and hour could trigger nondiscrimination laws, health and safety laws, leave and accommodation laws, and state-specific laws. It also clarifies some common questions about how to handle pay for workers when they can’t physically come to work.

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.

The goal of pharmaceutical development is to design a manufacturing process that can produce a drug product to a consistently high quality. This webinar sets out regulatory expectations for pharmaceutical development, taking account of the risk-based approach set out in ICH guidance documents (Q8, Q9, Q10 and draft Q12). It covers some examples of problems encountered during drug development.

It's easy to become a victim of the "To-Do" list, crisis management, and reacting to the latest fire. Unfortunately, that approach seldom leads to sustainable success. Focus on driving your daily action through the power of your vision and mission, plan strategically, and focus on results to get the progress your organization demands. In 2020 that means staying more concerned with your team members’ wellbeing and their needs.

An export compliance manual is a very important document for any company. It demonstrates the company’s commitment and understanding of the applicable export regulations. Further, it helps all the relevant employees understand their roles and responsibilities to create a compliance culture, minimizing the risk of unintentional export violations and avoidable import penalties.

This webinar identifies some of the problems HR and others responsible for onboarding have for trying to assess the needs of the person they have never met. You will learn what you can do to make onboarding the at home worker more successful. It will provide techniques for those you have onboarded to become more comfortable.

Attend this webinar to understand, what are the changes to the previous medical device regulation and how to implement the changes in your current quality management system in a simple and quick way. This need smart ideas to reach the right level to pass the quality management audit by your certification company or notified body.

The COVID-19 pandemic has turned everyday life upside down. Millions of Americans are now working from home. And while the current pandemic will certainly end, the transition back to “normal” life is likely to be gradual, with many predicting that the “normal” we once knew is a thing of the past and that the workplace employees return to will forever be changed. This situation presents multiple challenges for organizations looking to transition their staff back to on-site work. Whether they have been furloughed or transitioned to work remotely full time, re-onboarding needs to be well-planned and effectively communicated.

This training program will provide regulatory requirements (US) of 21 CFR Section 820.50 (purchasing control) for the medical device industry and illustrate the same with examples. It will furnish details on what purchasing/supplier control management systems should address.

Recent US FDA Inspections ("audits") indicate the "c" in CGMP is a moving target – with expectations growing upward! In this webinar, learn how to use the FDA's inspection flow charts and questions, past inspections, and key elements of the CGMPs to prepare for an FDA GMP Compliance Inspection. Recognize that past results are not an accurate of future inspection results. You will learn how to incorporate industry findings into your gap analysis and remediation plan.

Today more than ever before the job titles that we hold are not entirely reflective of the work that we do. Global teams and collaboration often place those in positions of team leadership that have the least foundation to manage all facets of complex projects. Project management requires specific knowledge of the key project facets that must be carefully managed. The interactions across divergent corporate functions, culture, language, and time zones all pose unique challenges to the new project manager.

For years the IRS has struggled with non-compliance by independent contractor and their tax payments. In assessing opportunities to close the tax gap (taxes due but not reported or paid), one of the greatest opportunities comes from expanding information reporting on taxpayers by payors – using forms 1099. For 2020 the IRS has added another form – the 1099-NEC. This time-consuming reporting obligation can be streamlined in a number of ways. Join us to learn more…

This training program will help articulate your business objectives and define the scope of your risk assessment. It will guide attendees in identifying the most appropriate risk assessment technique and plan and facilitate a risk assessment. Further, the session will help tailor a risk matrix to enable you to rate your risks.