
Global Medical Device Laws and Regulations: US, EU, and Canada
David Lim
90 Min
Product Id: 702842
This training on global medical device regulations will discuss the regulatory framework for medical devices in US, EU and Canada. It will outline systematic methods to identify and meet regulatory requirements and streamline the regulatory process in these countries.

FDA's Revised 510(k) Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions and Regulatory Compliance
Chris Cook
70 Min
Product Id: 702963
This medical device 510(k) training will help you understand the basics of 510(k) submissions and discuss how to develop and execute an approval strategy ensuring the fastest possible path to market.

Understanding and Administrating COBRA: Avoiding Costly Conflicts with Government Agencies
Kenneth Sprang
60 Min
Product Id: 702966
This COBRA (Consolidated Omnibus Budget Reconciliation Act) administration HR training course is designed to provide a comprehensive view of COBRA rule and it will also provide pragmatic tips on structuring and administering COBRA in your organization.

Must Have Enterprise Metrics for Financial Operations
Jon Casher
90 Min
Product Id: 702961
This Must have Enterprise Metrics for Financial Operations webinar will cover the key performance indicators and metrics for your financial operations, issues encountered and effective usage of these key metrics for your business.

Interest Rate Risk Management - What the Regulators Want
Walt Tillman
90 Min
Product Id: 702953
This webinar on Interest Rate Risk Management will highlight what the regulators expect community banks to do to effectively manage interest rate risk.

Dietary Supplements and Nutraceuticals: Compliance with FDA's Current Manufacturing Requirements
Mukesh Kumar
90 Min
Product Id: 701922
This training on FDA cGMPs for Dietary Supplements and Nutraceuticals will discuss current FDA regulations, GMP requirements and techniques to be compliant using easier, shorter and convenient strategies. Case studies of FDA audit experiences will be presented for easy understanding.

Auditing Privacy Companies - Implementing Internal Controls
Richard Cascarino
90 Min
Product Id: 702724
This training on data security will provide the tools to design and implement effective IT control structures and audit programs to help comply with the current data privacy and confidentiality regulations.

Medical Device Reporting for Manufacturers, Importers and Medical Device User Facilities
Kosta Makrodimitris
90 Min
Product Id: 702958
This webinar on Medical Device Reporting (MDR) will cover FDA requirements for importers, manufacturers and hospitals to report medical device adverse events. It will discuss current policies and guidances for Medical Device Reporting and provide update on upcoming regulations.

Advance HR Audit Techniques
Ronald Adler
60 Min
Product Id: 702952
This webinar will provide advanced training in planning, executing, and reporting HR audits. Critical HR audit issues will be review including developing an HR audit plan, identifying audit stakeholders, critical employment practice areas, and analyzing key performance and risk indicators.

Construction Fraud - Ways to Identify them and Prevent them
Denise Cicchella
90 Min
Product Id: 702954
This training on construction fraud prevention will discuss proven audits strategies and techniques for detecting and preventing common fraud and risk in construction activities. Attendees will also learn how to manage when fraud arises and the tips to effectively control construction costs.

Immunogenicity To Biologics: Processes, Impact On Efficacy And Safety, and Management Strategy
Chitra Edwin
60 Min
Product Id: 701551
This training will discuss the processes and effects of immunogenicity to biologics and the screening methodologies to measure immune response. Participants will learn how to apply regulatory mandates and about the commercial repercussions of unwanted immune responses.

Auditing Systems for 21 CFR Part 11 Compliance: Preparing Yourself for Inspection
Richard Poser(PhD)
90 Min
Product Id: 700970
This 21 CFR Part 11 compliance training will present a methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory, along with templates and forms that attendees can modify for their own business.

New QC Based on Risk Management: A Collaboration between CLIA and CLSI
Pamela Tayon Colker
60 Min
Product Id: 702385
This lab quality compliance training will provide a comprehensive overview of the Clinical and Laboratory Standards Institute (CLSI) Laboratory Quality Control Based on Risk Management; Approved Guideline, EP-23-A, produced in partnership with the Clinical Laboratory Improvement Amendment (CLIA).
3-hr Virtual Seminar: Learning the OSHA Recordkeeping Analysis
William Principe
3 hrs
Product Id: 702168
This 3-hr virtual seminar will show how OSHA analyzes record-keeping scenarios, applying the recordkeeping regulations, Frequently Asked Questions, and Interpretation Letters.

Ethical Decision Making in Organizations
Jason Mefford
75 Min
Product Id: 702831
This training on ethical decision making will provide an overview of organizational ethical concepts and will provide practical models to make best decisions while considering human and organizational values equally.

The Sunshine Act Final Rule
Mark Gardner
120 Min
Product Id: 702825
This session will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.

Telehealth/Telemedicine Regulations and Services in the USA
Kosta Makrodimitris
90 Min
Product Id: 702861
This healthcare compliance training will explain the current landscape of telehealth or telemedicine regulations in the US, reporting and documentation requirements, and the different telemedicine services and technologies.

Common Import Compliance Problems
Michael Laden
90 Min
Product Id: 702878
This customs and trade compliance training will review a number of common issues and problems related to compliance with U.S. import laws and strategies or solutions for mitigating those issues.

Creating a Quality Assurance Program for (Clinical) Research Sites
Amanda Shepler
60 Min
Product Id: 702855
This clinical research QA training will provide practical advice for clinical research sites on when and how to get started with building their quality assurance program. A table of contents of the most critical SOPs will be provided.

Information Security and Cybercrime Prevention Essentials
Peter Goldmann
75 Min
Product Id: 702839
This IT security training will summarize current and emerging cyber-threats and provide latest insights and advice from experts on how to protect the organization.