
Successful Steps in Documenting Unsatisfactory Employee Performance
Glenn Harris
75 Min
Product Id: 703385
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.

How to Prepare and Implement a Fraud Response Plan
Peter Goldmann
90 Min
Product Id: 703284
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.

Regulatory Compliance for Food Supplements in the EU - Registration, Labeling, Acceptable Marketing Claims
James Russell
90 Min
Product Id: 702545
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.

Performing a Cash Control Audit in your Healthcare Organization
Kevin McPoyle
90 Min
Product Id: 703374
This training on healthcare audit and compliance will teach the attendees best practices for conducting an audit of cash controls in a healthcare environment.

Are you responsible for Enterprise Risk Management Compliance: How to conduct a Compliance Gap Analysis for ERM, how to get started and what to expect?
Michael C Redmond
60 Min
Product Id: 703351
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.

FDA Regulatory Actions: It's Not Just about Warning Letters
Fredric Richman
60 Min
Product Id: 703344
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.

FDA Premarket Review of New and Modified Tobacco Products
Azim Chowdhury
60 Min
Product Id: 703127
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.

New HIPAA Rules, Tools, and Guidance - Latest Changes and What to Expect Next
Jim Sheldon-Dean
90 Min
Product Id: 703370
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.

How to file a 510(k) when your device is (or contains) software
Cheryl Wagoner
75 Min
Product Id: 703366
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.

The Two Midnight Rule - Guidance, status and key steps on implementation to avoid enforcement difficulties
Susan Lee Walberg
60 Min
Product Id: 703362
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.

Understanding ISO 13485 vs. ISO 9001 for Successful QMS in Medical Device Industries
John Chapman
60 Min
Product Id: 701003
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.

Employee Final Settlements: What You Can Do To Achieve Final Finality
Jonathan Evan Goldberg
60 Min
Product Id: 703298
This webinar will focus on techniques and strategies for negotiating employment dispute settlements. Attendees will learn best practices for ensuring finality.

How to Create Legally Compliant Commission Agreements
Stephanie Yang
60 Min
Product Id: 703343
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.

Preparing a Qualitative Risk Management Dashboard for your Board GRC process
Kurt Kendis
60 Min
Product Id: 703359
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.

Food Safety and Continual Improvement: Beyond Corrections and Audits
Oscar Rodriguez Gonzalez
60 Min
Product Id: 703361
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.

Managing the Trial Master File - Considerations for Moving to Electronic TMFs
Eldin Rammell
60 Min
Product Id: 703256
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.

Mobile Medical Applications: Software Regulatory Requirements
Tim Stein
90 Min
Product Id: 702812
This mobile medical apps training will outline the regulatory requirements for medical device software development processes, and the requirements for submissions.

Supplier Quality Management: Implement it Now or Pay for it Later
Les Schnoll
90 Min
Product Id: 703357
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.

Travel Pay and Expense Reimbursements - Do You Comply with the Law?
Miles Hutchinson
90 Min
Product Id: 703342
This webinar will explain various laws affecting travel pay and expense reimbursements. Attendees will learn best practices to comply with federal travel regulations.

Are you prepared for a regulatory audit from FDA or any other regulatory body?
Philip Russ
90 Min
Product Id: 703355
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.