Compliance Training Webinars for Regulated Industries

This medical device risk management webinar will provide attendees an overview of ISO 14971requirements and practical tips for implementing an effective system for managing risk. It will also discuss differences between the world-wide international standard ISO 14971:2007 and the Europe-only version risk management standard EN ISO 14971:2012.

This webinar will highlight the key elements of the Chemistry, Manufacturing and Controls (CMC) section of an IND and NDA application for a 505(b)(2) product using examples and case studies. It will also discuss role of Drug Master Files (DMFs), and cross reference authorizations.

This webinar will provide strategies to prevent and/or stop retaliation in the workplace. It will discuss how to recognize retaliation before it takes root; best prevention practices and strategies to safeguard employees.

This webinar will highlight the complex efforts in identifying and monitoring of Money Service Businesses (MSB). It will discuss MSB regulatory requirements, documentations, and scenarios that provide guidance on this high risk account type requiring extended due diligence.

This webinar on Part 11/Annex 11 audit and enforcement will explain what the auditors are trained to look for during a Part 11/Annex 11 “tag along” audit. It will cover inspection trends with examples of some recent 483s and warning letters and show what one need to do to have a successful inspection outcome.

This webinar will cover key definitions like cosmetics, new drugs, adulteration and misbranding, including key concepts like color additive restrictions and labeling requirements. Attendees will learn best practices for responding to Warning Letters.

This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.

This webinar will explain the process of customer due diligence and enhanced due diligence. It will cover customer onboarding, sources of funds and wealth, customer questionnaires including financial institution’s core competencies.

This webinar will explain how to undertake a voluntary self-audit of your organization’s pay practices. Attendees will learn how to determine who is exempt from the overtime provisions of the FLSA and how to document classification decisions.

This webinar will explain how to implement an effective records management program. Attendees will learn the advantages of record management to ensure safety and security of data.

This webinar will explain key steps in documenting employee unsatisfactory performance and progressive employee discipline. Attendees will learn how to clearly and effectively communicate to employees desired behavior and provide specific directives for employee improvement.

This fraud investigation training will teach attendees best practices for preparing and implementing fraud response plan. Learn how to conduct E-Discovery and forensic data analytics.

This 90-minute webinar will discuss regulatory requirements for food supplements in the EU. It will cover regulatory structure, registration, labeling, supplement ingredient criteria/safety and advertising considerations. Borderline products such as medicinal and herbal products will also be discussed.

This training on healthcare audit and compliance will teach the attendees best practices for conducting an audit of cash controls in a healthcare environment.

This webinar will explain how to conduct a compliance gap analysis for Enterprise Risk Management (ERM). Attendees will learn best practices to ensure ERM compliance.

This training will outline the possible consequences for failing to promptly and adequately correct significant violations related to cGMPs, new drugs or devices, labeling or other regulatory issues resulting in advisory, administrative and judicial actions.

This training on FDA regulatory requirements for tobacco products will focus on the premarket review of new and modified tobacco products. It will also discuss the impact of FDA deeming regulation for of e- cigarettes and novel tobacco products on premarket authorization requirements.

This HIPAA compliance training will focus on the privacy and security policies and Notices of Privacy Practices that must be updated to ensure compliance with the final HIPAA Omnibus rule. It will also discuss the new recommendations for accounting of disclosures regulations and the HIPAA audit program.

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.