Compliance Key - Compliance Online Training Webinars, Regulatory, Medical Device, FDA, Financia

Compliance KEY -  Enterprise Risk Management training Overview Do you use staffing agency employees ("temps") to augment your workforce? Do you ever "borrow" employees from an affiliate, subsidiary or parent company? Are you a franchisor with one or more franchisees, who in turn hire employees? Did you know that you may have employer responsibilities to those employees in addition to the ones actually on your payroll? Even if they are not on your payroll, even if you did not directly hire them, you may be a joint employer. You may have as much responsibility as the entity that did directly hire them or who does "payroll" them. Sound confusing? It doesn't have to be. This webinar will help de-mystify the concept of joint employment, and help you determine if and when you are a joint employer, and what to do - and not to do - if you are. Why should you attend this webinar? The National Labor Relations Board, the U.S. and state ...

Compliance Key INC  -  Hipaa Webinar   Overview This lesson will cover the latest SAMHSA and HIPAA updates which were released in January 2018 and December of 2017 respectively, and also cover multiple scenarios and FAQ's relating to Substance Abuse Records, Mental Health Records, Alcohol Abuse Records, and the proper ways to secure this information and/or release this information. An overview of a comparative analysis will be presented comparing SAMHSA to the HIPAA laws relating to protected health information in general. This lesson will be addressing how practice/business managers (or compliance offers) need to ensure their organization is complying with the Federal Substance Abuse and Mental Health Administration (SAMHSA) regulations (42 CFR Part 2) and how this differs from the HIPAA (Health Insurance Portability and Accountability Act) Privacy and Security Regulations. Both regulations carry significant civil and even criminal penalties if not...

ComplianceKEY -  Regulatory compliance training Overview The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised. Most important are the direct benefits to our primary customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration "All products are designed and developed to be of high quality; QbD provides a structured framework for developing, documenting and presenting development rationale, experience and knowledge of the formulation and the process, and to ensure manufacture of products consistently fit for patient use." Application of these principles can also benefit the pharmaceutical companies by improving manufacturing efficiency and promoting innovation. However, implementing these principles into the pharmaceutical development culture can be challenging. QbD involves a complex set of interactions, technologies and systems that ar...

ComplianceKEY -  Enterprise Risk Management training Overview This webinar will highlight the importance of effectively handling severance pay and agreements. It will discuss several frequently asked questions on employee termination, severance pay, severance agreements, and ERISA laws. Why should you attend this webinar? Managing employee terminations with severance arrangements can be tricky business. While the economy has improved, many employers continue to find themselves in the position of having to layoff corporate executives and managers and other valued employees. If you are an employer seeking to protect yourself from future lawsuits by offering severance benefits and agreements to departing employees in exchange for a release and agreement not to sue the corporation then you need to attend this webinar. Why? An improperly drafted release agreement could be invalidated and of no effect. Some severance packages are subject to ERISA. Some employer...

Compliance Key INC  - Bank webinars Overview This webinar will cover the latest updates for Form 1099-MISC, specific reporting requirements for various types of payments and payees, filing requirements, withholding requirements and reporting guidelines. It will also cover important filing due dates. the safe harbour requirements for de minimis dollar amount errors, and the due diligence steps that establish the reasonable cause exception to proposed penalties. Why should you attend this webinar? The regulatory landscape for Form 1099 compliance keeps shifting as Congress attempts to balance jobs growth with narrowing the tax gap and the IRS attempts to address fraud and identity theft issues involving information returns including 1099 Forms. Over the past decade a number of changes were written into the law and regulations. While some changes have been implemented and others have been repealed, all of them created compliance challenges for businesses...

Compliance Key INC  - Healthcare Training Online   Overview The new Dining Practice Standards were released in 2011. The Standards have been agreed upon by 12 clinical standard setting organizations and recognized by CMS. A second Task Force developed a Toolkit of model policies and procedures, brochures for families and residents and other tools to help teams operationalize the Standards such as an Informed Choice form. In an overview format, learn about the Standards, the evidence-based research that backs them, how they were built upon CMS nursing home requirements and the new tools now available, from the facilitator of both the Creating Home || symposium and subsequent task forces. Be inspired to use the new standards to keep improving yours. Why should you attend this webinar? The new Dining Practice Standards are new standards of practice for all disciplines and help professionals to help people living in nursing homes to eat what they want...

Compliance Key INC  - Life Science Webinars   Overview Compressed air for pharmaceutical use is considered a critical utility as many of its applications involve direct contact with the pharmaceutical product. The design, construction and monitoring of a compressed air system is essential for maintaining a quality system without contamination of the product. Proper testing of compressed air quality according to international standards is important for both validation and ongoing monitoring of the system. Why should you attend this webinar? Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed air system with its individual components is provided. Engineering schematics are ...

Compliance Key INC  -  Medical Device Training   Overview This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both. The confusion over the original FDA regulation and its subsequent "selective enforcement" will be explained Why should you attend this webinar? Companies want to transition to electronic records but are afraid of compromising their quality system and receiving 483...