Compliance Training Webinars for Regulated Industries

This training program will explain how to manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. The program will also help in getting projects completed on time and within budget.

This training program will offer participants an understanding of the concept of E&L (Extractables and Leachables) studies and about developing an E&L study in a reasonable and pragmatic way - based on regulatory requirements, guidelines and recommendations.

This training program will classify common forms of ATM skimming fraud, POS skimmers, and POS malware, and also identify appropriate mitigation strategies. The course will further analyze why EMV will not stop ATM fraud and POS skimming fraud.

This training program will discuss fundamentals of infection and the use of materials/drugs to fight infection, FDA regulatory approvals for drugs and materials used to fight infection, and future thoughts on approaches to fight infection.

This training program will discuss how cyber-attacks affect payment processing. It will highlight to attendees how best to record appropriate sound business practices for managing operational risk due to a cyber-attack. Attendees will also learn to identify critical operational communications, from internal staff to customers and institutions to vendor support.

This training program will discuss the many advantages in obtaining a CIA designation. In addition to the vast audit and business knowledge you are exposed to, it can lead to promotions and pay increases. You become a valuable asset to your organization. And while the test is difficult, it is not impossible. It is meant to make sure that when you carry the CIA designation, people know that you have an excellent grasp of audit and business knowledge.

This training program explains the details of loan portfolio management and factors of macro economic, industry, business and management that must be considered. The instructor discusses the process of examining the quality of credit file documentation, including assessment of the credit memorandum and loan documentation. Participants will also understand the loan grading techniques and the check points that are needed to complete a full loan review.

This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.

This training program will help attendees understand what adverse events, serious adverse events and unanticipated problems are, and why reporting them is important to a study hypothesis and is key to keeping subjects safe while on a clinical trial. They will also learn the responsibilities of the sponsor, site/clinical investigator and regulatory agency in reporting adverse events.

This webinar will discuss the common AML, SOX and Licensing control failures and how to detect and prevent them. The instructor will discuss the legal impact of non-compliance on banks and financial institutions, red flags and how to strengthen your internal controls to mitigate risk.

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course.

This training program will focus on understanding the drivers and benefit of using worksheets not only as a prompt for recording details but also in reducing efforts of the analysts and auditors in a GLP/GCP bioanalytical lab.

This webinar will discuss the bane of new technology and social media in regards to employers’ and employees’ privacy. The instructor will discuss e-compliances that employers need to adhere to avoid privacy suits. He will also cover the risks of information breach and defamation claims from electronic employee postings. Participants will know how to deal with online privacy and harassment claims and ways and limits of disciplining employees’ online presence. The course will also examine how to legally use Internet postings, profiles and other content in hiring decisions.

This training program will instruct attendees on clearly classifying products. It will discuss how best to create lasting compliance procedures which will ensure continued classification success. Attendees will also master legal classification concepts which apply to each classification exercise.

This ERM training program will discuss how today’s enterprise risk evaluation and control and impact analysis include identifying enterprise threats, which can truly lead not only to a disruption but also to the destruction of an enterprise.

This webinar will enhance attendees’ knowledge of corporate responsibility for financial reports, disclosures and certifications relating to SOX Sections 302, 401, 404, 409, 802, 906 (Sarbanes-Oxley Act) by helping you understand the levels of corporate responsibility and certification.

This training program will discuss stem cell sources and how to control stem cell differentiation, technologies (FDA and non-FDA) that exist in stem cell technologies, and the future directions and opportunities that exist for stem cell technologies.

This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.

This training program will explore why planning and implementing an information management solution can be a daunting task. Composing policies and procedures is a good start, followed by testing in small groups. But a lot of people are resistant to changing their work practices, especially if they have been working for an organization for a long time. The worst thing that can happen is that staff appears to be compliant with the new plan, but has found a way to continue their prior practices under the radar. The solution to this problem is a comprehensive initial and continuing educational plan.

This webinar will demonstrate a conceptual framework and thought process to address risk management. It will discuss the significance of risk management processes with emphasis on causes of risk and risk preventives. The instructor will explain the best practices, roles and responsibilities, risk types and how to prevent them.