Compliance Training Webinars for Regulated Industries

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 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.

This training program will offer an interpretation of the latest ruling of Reach SVHC. It will also discuss the RoHS directive – the four substances added to the restriction list in Annex II.

This training program will highlight how one can effectively manage risks resulting from Foreign Corrupt Practices Act (FCPA) claims. Presented by the former Inspector General of the SEC, who served in senior-level positions in several federal agencies, the webinar will provide practical lessons on how to manage FCPA claims, devise effective compliance programs, conduct internal investigations and achieve a culture of compliance in an organization.

This training program will explore why human factors has become a vital part of the FDA’s medical device pre-market approval/clearance process. The FDA Center for Devices and Radiological Health (CDRH) recently issued two guidance documents on human factors that are key elements in determining pre-market submission strategies for manufacturers. In this webinar, attendees will learn how to provide clear and complete human factors submissions meeting the intent of these guidance.

This training program will provide an overview of the FY 2016 Omnibus and FY 2017 Budget Request. It will explore why the Renewable Energy ITC and PTC are still important and relevant to the industry. The instructor will also elaborate the role of renewable energy in the administration’s Climate Action Plan and highlight the economic incentives that work in your industry.

Regardless of company size or complexity, all successful financial close processes require continuous communication, comprehensive documentation and a flexible, responsive organization. This training program will focus on 10 critical methods that you can use to dramatically improve your Record to Report (R2R) process. The R2R or Financial Closing Process is the centerpiece of the controllership function. This program will examine the process that ranges from transaction processing through internal and external reporting, and it incorporates everything from internal controls, the corporate organizational hierarchy - its people, processes, and technology.

This training program will help attendees understand the requirements of the FDA UDI regulation and the labeling requirements of the UDI regulation. The program will also focus on data elements that make up a UDI compliant barcode and GUDID data attributes and submission process.

This training program will examine key questions on how California’s future medical cannabis market will look like when it comes to regulation. In the next two years, multiple state agencies will be involved in filling in the blank spaces left by MMRSA. For example: What will licensure fees look like? How will “edibles” be regulated in California? In the background, a new President will be elected soon and this could influence the future of all state-based medical cannabis markets. Insight and opinion on all these issues will be provided by a regulatory expert with years of expertise in influencing state and federal decision-making and policy.

This HR compliance training explains the best practices to adopt in order to effectively communicate compensation related issues to employees. You will also learn creating a base pay system that is sensible and fair.

This training program will list and discuss documents required to complete the five steps in the documentation process. On completion of the program, attendees will be able to provide a broad overview of the loan documents’ provisions to borrowers and loan processing management techniques.