Compliance Training Webinars for Regulated Industries

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.

This webinar will help you to understand the expectations of complaint handling and medical device reporting. You’ll also learn about lessons from 483s and warning letters. We’ll discuss how you can develop your processes to efficiently and effectively manage complaints and MDRs. Also, we’ll discuss how to link these processes to failure investigation, recalls, and CAPA (Corrective and Preventive Action). We’ll cover best practices, so you can be prepared for an FDA inspection.

Creating a culture of compliance is an important risk management strategy. Recent corporate collapses have reflected the need for good corporate governance and an effective compliance program is an integral part of this structure. This introduction to Compliance Management provides a blueprint for compliance professionals to follow to ensure that the risk profile in his/her organization is limited by a thorough understanding of the individual regulatory environment.

The webinar will provide you with valuable information about setting up a food fraud vulnerability assessment so that you are better prepared to meet the food fraud-related requirements of GFSI Certification Programme Owners and the economically motivated adulteration requirements of the U.S. Food Safety Modernization Act.

Learn about change control process and procedures in regulated industries. This webinar help you understand and successfully apply change control steps and best practices.

Attend this webinar to learn how to evaluate the trade compliance risk for your worldwide subsidiaries and how to ensure that your worldwide subsidiaries are adequately managing their trade compliance risk.

This webinar will provide practical learning for implementing design thinking principles into your meeting management techniques. Learn how to facilitate interactive meetings which motivate teams to quick alignment. Understand how to “group” synthesized data for buy in from all parties.

This training program will detail why SR Letter 11-7 has become the gold standard for model risk management, with its principle being adopted not only by banks but also virtually all U.S. financial institutions.

Whether you are being audited or conducting and audit, understanding the fundamental is critical for both quality system and regulatory compliance. In this webinar we will examine the concepts of conducting audits and being the subject of an audit (internal or external).

This webinar will focus on the challenge of the patient with an extended length of stay. It will focus on characteristics that can assist hospital case management staff in identifying patients that are potential candidates for extended length of stay, with strategic interventions to decrease both the number of patients in this group and a decrease in the length of stay of any patient reaching extended length of stay.