Compliance Training Webinars for Regulated Industries

The Webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

This healthcare webinar will provide the latest guidance and status on implementation and enforcement of the ‘Two-Midnight Rule’, which is a part of the CMS' IPPS 2014 regulations. It will also provide guidance on key steps to implement in order to avoid enforcement difficulties down the road.

This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements. ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820. This presentation will help you to understand ISO 13485 and implement a successful quality management system, comparing it to ISO 9001 and FDA & European Union requirements.

This webinar will focus on techniques and strategies for negotiating employment dispute settlements. Attendees will learn best practices for ensuring finality.

This webinar will focus on the requirements of a commission agreement in California and differences between an earned commission and an unearned commission. Attendees will learn best practices for creating commission agreements for California employees and how to avoid the pitfalls.

This webinar will explain the fundamentals of a qualitative dashboard. It will discuss the steps in the process necessary to design, develop and implement a risk management reporting dashboard for GRC purposes in a short and efficient time frame.

This webinar will present a proactive approach to improve food safety management systems that go beyond corrective actions to deviations and findings from external audits. It will focus on the continual improvement methodologies to speed up or optimize processes, solve problems and manage complexity.

This clinical compliance training will review what issues one needs to consider if one’s organization is thinking about introducing an IT solution for the management of trial master file content. Attendees will gain an understanding of how to comply with the regulatory requirements that are pertinent to the maintenance of the TMF and how to choose efficient supporting TMF processes.

This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.

This webinar will discuss FDA's requirements for medical device supplier management and the controls you need to have in place to ensure compliance with quality. It will cover how to structure a supplier quality agreement and the tools and methods you need for evaluating and assessing suppliers.

This webinar will explain various laws affecting travel pay and expense reimbursements. Attendees will learn best practices to comply with federal travel regulations.

This FDA audit training provides an overview of the audit readiness process from internal evaluation of your quality systems to the logistics of the audit itself; with key emphasis placed on equipping you and your team with the skills needed to present expert testimony during interviews with regulators.

This webinar will discuss how to do a security risk analysis to meet the requirements of HIPAA, HITECH and Meaningful Use attestation. It will describe ways for effectively completing a risk analysis at the organizational level, the network level and the application level.

This webinar will help Sponsors, CROs and study sites running clinical trials in the EU and internationally; understand the important, updated compliance requirements concerning the new EU Clinical Trials Regulation due to be enacted in 2016 and which will replace the 2001 Clinical Trials Directive (CTD) (2001/20/EC).

This webinar will provide tools and tips for optimizing imports contracts to ensure compliance and reduce risk. Attendees will be able to review their contracting practices, PO forms and purchasing procedures to make the best use of their advantages as a buyer.

This clinical research compliance training will explain in detail the list of required regulatory documentation for clinical trials for industries such as pharmaceutical, biotechnology, medical devices and diagnostics. It will also review many of the documents in terms of required content and structure.

This webinar will explain numerous types of accounts receivable fraud (A/R fraud). It will provide attendees best practices for detecting and preventing all major forms of this type of fraud.

This webinar on purchasing card compliance highlights the evolution of IRS involvement in the use of credit cards for business use, more commonly referred to as Purchasing Cards. It will explain changes in the way these transactions are governed so your business can operate optimally in the credit card space.

This webinar will explain the anti-bribery and accounting provisions of the Foreign Corrupt Practices Act (FCPA) and will also discuss the UK Bribery Act. Learn the best practices for avoiding penalties for FCPA, UK Bribery Act, or local law violations.

The webinar will provide detailed information on how to comply with NAFTA basics such as Harmonized Tariff classification, valuation, Country of Origin determination and marking requirements. Attendees will also learn how to comply with NAFTA’s often complex rules for eligibility thus mitigating the risk of violations that are subject to stiff fines and penalties from US, Canadian and Mexican Customs authorities.