Compliance Training Webinars for Regulated Industries

This webinar on FDA's design control requirements will discuss how a requirements management approach consistent with the CMMi Requirements Management KPA, helps companies meet FDA's Design Control requirements.

This training program will concentrate primarily on establishing a philosophy and program for salary administration that will be in alignment with your organization’s business strategy, be understandable to management and employees and compliant with applicable labor laws.

This training program will examine the many facets of disposable bioprocessing systems that incorporate a wide scope of polymeric single-use products. Single-use disposable technologies, from upstream to downstream processes, will be reviewed as related to the use of polymeric devices. Specific attention will be given to the related applications used in the production of biopharmaceuticals and pharmaceuticals.

This training program is designed for food defense and food safety practitioners who are preparing for implementation of the Intentional Adulteration rule. Those who have existing Food Defense Plans should understand how the vulnerability assessment requirements may go beyond most existing food defense plans and what considerations will be needed to comply with the rule. Operations which have relied on the FDA supplied Food Defense Plan Builder software tool should know the limitations of the existing tool, and how to overcome them, and who is qualified to do so.

This training program will detail the Affordable Care Act law and its rulings. The session will also examine benefits administration and how to ensure compliance and the future of Obama Care.

This training program will define the role of ethics in sales and marketing. Attendees will understand the relationship between sales and marketing today and how it has changed. The program will also discuss the buying process of today’s customer and set out best practices for developing a code of ethics.

This training program will explore how development and deployment of PCI DSS (Payment Card Industry Data Security Standard) compliant networks can assist your business to secure those electronic assets that the business considers vital. The principles specified in PCI DSS, which the program will discuss, can be a guide for all organizations that wish to secure their data.

This training program will introduce the consumer lending process from the initial application to closing and documentation. Proper analysis of consumer loan requests is more important today than any time in the history of banking as a result of the current economic environment worldwide which has left many consumers in a weaker financial condition than in the past. For this reason and the need for banks to continue growing the consumer loan portfolio safely, it is important for bankers to adjust their lending practices to insure the next consumer applicant is not becoming overextended and unable to meet their obligations.

The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance.

This training program will address the daunting task of conveying complex technical data clearly, concisely, and purposefully to technical and non-expert audiences alike. Writing examples from diverse technical fields makes this webinar highly relevant. The program will build a foundation for learning by identifying the qualities of effective writing and the roadblocks to overcoming them.

This training program will explore the underwriting and reporting on commercial real estate, construction loans, acquisition and development loans and multi-family unit loans. In doing so, several samples of proven credit memos will be examined to insure bankers are covering the areas required by the banking regulators.

This training program will elucidate the similarities and differences between the FDA and Health Canada promulgations of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.

This training program will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Attendees will learn how to identify and avoid potential pitfalls during deviation investigations.

This training program will assist 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. It will help attendees in determining how well your company is positioned to defend your FDA submission.

This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.

This webinar will discuss the XBRL basis, terms and taxonomies. XBRL, eXtensible Business Reporting Language, a global electronic information format designed to transmit and store business information in a machine readable format, is now mandated by U.S. securities and exchange commission. Instructor will discuss the functioning of XBRL, why it is needed, tagging levels and definitions and help understand the XBRL SEC Viewer.

This webinar will make a distinction between nomenclatures (serious adverse events, adverse events, anticipated events, unanticipated events and unanticipated problems) and discuss the reporting requirements to the FDA and Office for Human Research Protections (OHRP).

This training program will discuss the attributes of a successful system implementation and detail how to convert the successful implementation expectations into measurable metrics. The program will also detail establishing project plans and help identify the resources needed for the project and scheduling tasks.

This 3-hr virtual seminar will cover areas where human resources should be especially vigilant in times of complex labor laws, changing environments and reorganization of the workforce. We will discuss “hot spots” and specific areas at risk to be sure they are addressed as well as new laws which must be followed, giving added advice to anticipate future needs and obligations.

This healthcare compliance training will explain how to organize and negotiate physician financial arrangements in order to be ready for internal and external audits. Attendees will learn how to comply with regulatory requirements of Stark Law, the Anti-kickback statute, the False Claims Act (FCA), and IRS tax-exemption code related to physician arrangements.