
EU Medical Device Regulation (MDR) – Updated CE Marking Process and ISO 13485:2016 Expectations
Robert J Russell
90 Min
Product Id: 705801
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.

The Provider Self Disclosure Protocol (SDP) and the OIG- Compliance: Self - Reporting to OIG - When should this happen and how to do it?
Laura S Hargraves
60 Min
Product Id: 703203
This training on OIG Self-Disclosure Protocol will help the attendees on the revised self-disclosure protocol (SDP), the process and procedures for self-reporting and the risks of not self-reporting. It will also review the need for the organization to be aware of excluded entities.

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Dr. Ludwig Huber
75 Min
Product Id: 701242
This excel validation training / webinar will demonstrate how to design spreadsheets for Part 11/GxP /SOX/HIPAA compliance. And how to document planning, specifications, installation, testing and changes to meet FDA requirements.

Cracking the Z Codes: Discovering Hidden Treasures with Value-Based Care
Pamela Joslin
60 Min
Product Id: 705888
In this webinar attendees will learn the requirement by the Centers for Medicare and Medicaid Services (CMS) on October 1, 2015 to begin coding healthcare claims for reimbursement using the International Classification of Diseases-Tenth Revision (ICD-10) has greatly expanded the number and specificity of codes available to describe healthcare encounters. Among these new codes (Z00-Z99) are hundreds that describe supplemental factors and additional detail related to the healthcare encounter.

Allergen Cleaning and Risk Mitigation for FSMA
Gina Reo
60 Min
Product Id: 705942
In this food safety webinar attendees will learn how to set up a robust allergen control plan with latest approaches for cleaning, validation, monitoring and preventative controls required under FSMA (Food Safety Modernization Act). Also attendees will learn insights for testing, laboratory review and cleaning practices to improve or review their allergen management program.

Critical Concepts to Understand the Balance Sheet, Income Statement, Cash Flow and Retained Earnings
Lynn Fountain
60 Min
Product Id: 704834
Rather than focus on the computations and tactics of each of the statements, this training program will cover the important concepts of how the statements interact and relate to each other providing management with the critical information needed to manage financial stability of their organization. It is important professionals recognize that no one statement tells the complete story, but combined they provide a powerful tool for management.

Successful Water System Sanitization
T.C Soli
60 Min
Product Id: 705825
This webinar will discuss common problems of sanitization process, the causes of sanitization failures and teach how to troubleshoot and take remedial actions with respect to material, construction methods, biofilm removal process and timing of sanitization.

Design for Quality and Compliance
Susanne Manz
120 Min
Product Id: 705916
This 2-hour webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. An effective and efficient design control process results in a predictable product development process with improved quality and compliance result. This webinar can help you create a design control process that is a competitive strength for your company.

Winning Strategies for Successful US FDA Inspections: Conducting an Effective Mock Pre-Approval Inspection & Implementing Robust Remedial Measures
Nada Kuganathan
90 Min
Product Id: 705925
In this Webinar, attendees will learn the winning strategies for successful FDA inspections and as how to conduct robust mock audits during pre-submission and post submission stages of drug product applications. This webinar will also include strategic approaches to implement robust remedial measures to mitigate the potential quality and compliance risks identified during the mock pre-approval inspection in a proactive manner.

What the US, Canada and Mexico Want from a New NAFTA
Raymond Sullivan
60 Min
Product Id: 705575
This webinar will discuss the issues involved in North American trade, the areas and industries that NAFTA negotiations will likely affect and how you can ready your business for a potential impact.

Boots on the Ground - Ending Workplace Falls
Allen Woffard
60 Min
Product Id: 705926
This OSHA compliance webinar will train you and your staff to the potential fall, then preventing it before it occurs. Also you will learn how to train and inspect the worker to your site, inspect the sites walking and working surfaces, environmental related fall accelerators, how to perform a field sobriety test.

Make Your Company ROAR (Recruit, Onboard, Actuate, and Retain)
Bill Humbert
90 Min
Product Id: 705899
In this webinar, recruitment best practices will be discussed. You will learn the steps that are required to be a successful recruiter. It will emphasize not only on attracting the top candidates but also how to successfully onboard and retain them.

Complaint Handling, MDR's & Recalls
John Chapman
60 Min
Product Id: 700830
This presentation will review the regulations and point out some of the pitfalls in complaint handling and reporting.

The False Claims Act (FCA) and International Trade
Martin Behr
60 Min
Product Id: 705937
In this webinar attendees will learn about False Claims Act in details - how you and your company may suffer if you or your company has or is violating federal (and state and local) law & how you can use your knowledge to make a lot money and help U.S. governments right wrongs.

Panama Papers and PEP Screening - KYC and Sanctions Filtering
Armen Khachadourian
90 Min
Product Id: 704630
This training program will explore the operational implications of dealing with heightened-risk categories such as PEP screening at the heels of the Panama Papers controversy. The program will also discuss the current changes in the marketplace and expose the new faces of AML and examine areas of PEP regulation that pose present and future challenges for regulated businesses.

Modern Financial Modeling Using Special Excel Tools for Budgets, Forecasts and Projections
Joe Weil
100 Min
Product Id: 705898
This training program will help attendees to understand the financial modeling concepts to construct powerful & effective templates and Excel's linear regression analysis to model your firm's sales forecast, identifying key revenue and cost drivers and charting techniques for report forecasting results to top management.

Achieving Success and Compliance in the Supply Chain
Danielle DeLucy
60 Min
Product Id: 705907
This webinar will help attendees to understand the quality issues and methodologies that are relevant in current supply chain management to improve your customer satisfaction.

Compliance Obligations of Financial Institutions Concerning Services to Military Personnel and Veterans
Michael Tyler
60 Min
Product Id: 705936
This program will help attendees to understand the background of rules and specific compliance obligations involved in providing protections specifically to serving military personnel and to veterans from Banks, Credit Unions and some other financial institutions.

Sexual Harassment in the #MeToo Era
Melvin K Patterson
60 Min
Product Id: 705935
In this sexual harassment training both employers and employees will learn about how to create a better workplace cultures that oppose and prevent workplace sexual harassment by understanding the social and legal background of sexual harassment, identifying different types of sexual harassment, interaction between sexual harassment and other laws, critical developments and legal points of sexual harassment and potential remedies.

ASTM 2500: Lessons Learned Through a Decade of Implementation
Kelly Thomas
90 Min
Product Id: 705911
This validation training program will discuss regulatory requirements from the FDA, EU and ICH perspective, review all the detailed guidance on the concepts found in ASTM E2500 to help industry professionals understand how to implement a validation program based on the ASTM 2500 Approach.