Compliance Training Webinars for Regulated Industries

This 510(k) and risk management webinar will discuss FDA expectations for information supplied in the 510(k) application and how to best demonstrate that product is safe.

This webinar will explain how to conduct an effective internal audit program. Attendees will learn the benefits of a well-designed and executed internal auditing program for GMP compliance enhancement, management informatics and for avoidance of whistleblower actions.

This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.

This webinar will discuss the FDA rules and regulations regarding the potential of using live cells in medicine. It will cover FDA guidance documents for cellular and gene therapy and major differences between the rules in the USA and other countries.

This CBP compliance webinar will discuss how to identify critical areas of customs valuation that are often overlooked by importers and customs brokers. Attendees will learn best practices for avoiding costly investigations, audits as well as monetary penalties.

This webinar will explain in detail the reporting requirements under the Affordable Health Care Act, calculating group term life insurance and tax ramifications of third party sick pay. Attendees will gain an understanding of the different types of health plans outside of the typical group health insurance and how each must be handled and reported on Form W-2.

This webinar will explain the basic components of a good offer letter, employment agreement, or termination letter. It will provide attendees HR best practices for drafting these documents to avoid common mistakes and pitfalls.

The presentation will discuss the proper use of FMEA in risk management and how to recognize and avoid the traps associated with this tool in order to have a more efficient risk management process. Most medical device manufacturers use FMEA as a part of their risk management system. Most medical device manufacturers use FMEA as a part of their risk management system.

This webinar will explain the requirements of ITAR 126.18 regarding the transfer of defense articles (including technical data) to dual and third-country nationals employed by approved foreign end-users. Attendees will learn how to ensure compliance with the ITAR and avoid violations and penalties.

This webinar will explain the Good Manufacturing Practices (GMP) requirements. Attendees will learn strategies for site preparation and hosting of an inspection.

This webinar will provide tips and techniques on how to research and identify appropriate predicate devices for a 510(k) application.

This webinar will teach attendees how to develop more efficient data management SOPs for their company, whether they perform these tasks in-house, oversee this task that a vendor provides, or outsource this task in its entirety.

This webinar will explain the fundamentals of SBA lending and the two most used and popular SBA’s programs: the SBA 504 Program and the SBA 7a Program. Attendees will learn how to document SBA loans, as well as closing and funding SBA loans.

This webinar will address current HR issues regarding the FMLA and ADA. It will discuss the common mistakes that managers make when applying these laws and how to avoid them.

This webinar will explain how to generate a practical and compliant methodology to handle equipment requalification. Attendees will learn about common pitfalls to avoid when requalifying equipment.

This training on the Foreign Corrupt Practices Act will focus on the anti-bribery and accounting provisions of the FCPA and will explain the activities and conducts that are prohibited by the FCPA. Learn the best practices and strategies for avoiding criminal and administrative penalties for violating its provisions.

This webinar will explain how to manage employee terminations and exits. Attendees will gain understanding and discover recommended best practices and techniques for ensuring compliance, fairness, and reasonable support during sensitive employee terminations and exits.

This webinar will discuss the required procedures for conducting workplace drug and alcohol testing for the federally regulated transportation industry. Attendees will learn how to ensure compliance with the FAA's Drug and Alcohol Testing Regulation.

This webinar will explain FDA regulatory records requirements for medical devices and finished pharmaceuticals. It will cover statutory requirement, required content, format, purpose, retention, and structure for regulatory records for both medical devices and pharmaceuticals.

This webinar will explain how to implement an Enterprise Resource Planning (ERP) system by integrating a company’s existing quality system. It will cover selection, analysis, initiation, design, validation and test phases, including change control.