Compliance Training Webinars for Regulated Industries

This webinar will explain similarities and differences between COSO v ERM frameworks. Attendees will understand key advantages of using the ERM framework over the updated COSO 2013 model.

This webinar will discuss regulatory requirements for adverse event reporting for dietary supplements and OTC products. It will explain the similarities and differences in reporting adverse events for dietary supplements and OTC products and will also discuss trends in FDA audit for these products.

This webinar will help you enhance your current strategies of coaching employees & teams for sustainable peak performance. You will be given that are designed for effective coaching, defining roles, measuring performance & implementing plans.

This webinar will review the changes introduced by the new European Union ("EU") Clinical Trials Regulation and the implications for future clinical trials.

This webinar will help you understand the applicable electrical safety practices in the workplace and review the responsibilities and requirements for a person qualified in the OSHA and National Fire Protection Association’s (NFPA) standards.

This webinar will explain the regulatory path of an in vitro diagnostic (IVD) and Laboratory Developed Test (LDT). It will discuss the CLIA regulations for Laboratory Developed Tests (LDTs), including companion diagnostics (CDx) and how these differ from the FDA’s authority.

This webinar will help attendees understand how to respond to inspection and audit findings using CAPA (Correction and Preventative Action) for all types of GXP inspections and audit (eg GCP, GLP, GMP, GPV).

This webinar will explain the requirements of the Omnibus Final Rule regarding Business Associate Agreements (BAA’s) including what it was, what it is now, and what it might be in the future. It will discuss responsibility, liability, indemnification, injunctive relief, and other topics that are causing, or may be causing, contention.

This webinar will explain how to prepare for an unannounced OSHA inspection and avoid citations and fines. Attendees will learn how to effectively use Job Hazard Analysis (JHA) to prevent accidents in the workplace.

This webinar explains the excise tax on medical device manufactures that went into effect on January 1, 2013, including the devices it covers and the effective selling price for tax purposes.

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.