Compliance Training Webinars for Regulated Industries

This training program will discuss each of the critical aspects of freeze drying and the related effects of variables. The course will also discuss sublimation rate variability, heat transfer, loss of protein activity, and freezing effects on primary drying.

This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.

This training program will discuss why it is important for you to be better aware of and to become better acquainted with FDA inspection best practices. In particular, the webinar will detail a list of Dos and Don’ts before, during and after the inspection.

This training program is designed for hospice and home health directors and administrators who participate in leadership of their programs. As a health care executive, or hospice/home health provider, you should be very concerned about the growth of your program. A program’s ability to provide care with necessary resources and personnel is dependent on your ability to maintain census and census growth. As a Medicare/Medicaid/commercial insurance/managed care hospice or home health provider with the environment of lower reimbursement, it is even more critical to grow your program to survive and thrive.

This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

Personnel records are documentation of an individual's employment history encompassing all employment-related information collected and maintained by the employer. These essential documents form the foundation upon which employment actions are based. This webinar will illustrate key concepts in managing personnel records to protect your organization from potential exposure and security threats.

For HR representatives and business owners of mid and large sized enterprises, this course will elaborate current trends and updates on the Affordable Care Act. It will emphasize the need for compliance with these updates and list ACA penalties for non-compliance.

This training program will help attendees distinguish between urgent alarms and non-urgent alarms. It will further offer guidance on how to validate alarm effectiveness.

This training program on lean documents will present a fresh departure from general practices, while building upon proven principles. The theory of lean documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and push systems, many traditional document practices are artifacts of a flawed approach. This webinar will highlight how lean configuration comes from the same principles, and utilizes the unique power of software solutions to take over functions that had previously burdened controlled paper documents.

This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.

This webinar will highlight the opportunity to define enhanced diligence that can be used for conducting an effective high risk review in order to ensure compliance with Bank Secrecy Act (BSA) regulations and regulatory expectations.

This training program will discuss the basics of the Medical Device Reporting (MDR) regulation and review the process for preparing and submitting Electronic Medical Device Reports (eMDRs).

This training program will explain to participants the processes and requirements to become CLIA certified. All U.S. laboratories performing testing of human specimens for the diagnosis, treatment or mitigation of human disease are required by law to be certified under CLIA. Becoming CLIA certified is a complex process, and this webinar will provide a roadmap to obtaining certification, saving time, frustration, and resources.

Understand the regulations applied to most goods imported into the United States and the U.S. marking regulations to follow before exporting goods into the U.S.

The webinar will discuss why policies and handbooks are important and strategies for developing or updating your policies and handbooks. You will be provided with tools for determining the laws that are applicable to your company and resources for developing an employee handbook.

This webinar will teach attendees how to prepare for, manage, and follow up on FDA inspections. It will discuss common pitfalls to avoid during an inspection.

This training program will update participants on the developments regarding OFAC sanctions, OFAC enforcement trends as well as related export control traps for the unwary. The discussion of OFAC sanction developments will give participants an appreciation of the new war chest of punitive measures being deployed in recent executive orders.

This training program will discuss the changes to initial and closing disclosures relative to TILA and RESPA. It will offer attendees a clearer understanding of changes to variance thresholds, affiliate relationships, and illustrate the importance of knowing your fees and avoiding closing delays.

This training program will discuss the historical context of India's current trade policy and overview India's commercial climate and market access issues. The course will also highlight top import and export compliance errors, and strategies for smooth trade facilitation into and out of India.

This training program will provide participants with an essential, basic understanding of U.S. rules and regulations governing international trade. The regulations contain required (and prohibited) business conduct, with penalties for failure to comply including fines, loss of export privileges, and even jail terms. In many cases, banks are required to police transactions they handle and report violations.