Compliance Training Webinars for Regulated Industries

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.

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.

This training program will offer best practices for staying in compliance with the Fair Labor Standards Act when the proposed regulations are released while exploring the critical nature of the right communications. It will be followed-up by a 60 minutes complimentary Q&A Session(Series2)on Monday, May 9th 2016.

Beginning with the initial interest and concluding with payment, this training program will provide a handy flow-chart for consideration and guidelines of exactly how to execute a successful transaction, from conception through connection and up until collection. It also indicates options available to the exporter based on size and value of shipment, country of destination and type of buyer.

In this training program, attendees will learn the types of FX hedge programs typically utilized by corporations and the hedge instruments typically used by corporate hedgers such as forwards and collars. They will also gain an understanding of the concept of view-neutral hedging.