EU MDR 2017/745 Custom Made Medical Devices
Juan M Campos
60 Min
Product Id: 706696
In this webinar, you will learn how to manage custom-made medical devices according to EU MDR 2017/745 and fully comply with the new EU Medical Device Regulation which is mandatory starting 26-May-2021.
Another Outbreak, Another Recall-Resting on our Laurels is not Enough
Michael Brodsky
60 Min
Product Id: 706694
Attend this webinar to learn how to adapt the basic tenets of a food safety strategy: Prevention, Intervention, Protection, and Education. Get an overview of FSMA and the Safe Foods for Canadians Act as they relate to regulations about prevention.
CFPB's New Proposed Debt Collections Rules
Justin Muscolino
60 Min
Product Id: 706590
The CFPB's debt collection rules will have a major impact on how and when consumers are contacted to pay-off debt. The consequences of not complying can have severe consequences for businesses. This webinar will discuss businesses' and consumers' rights under the new rules.
Statistical Elements of Small Sample Sizes and Only 3 Lots in Process or Product Validation
Elaine Eisenbeisz
90 Min
Product Id: 706635
Attendees of this webinar will learn statistically valid methods for using small sample sizes and for using lots as few as 3 when validating processes or products.
The focus of this webinar is on providing the information needed for attendees to understand the concepts of risk in relation to process validation and to be able to compute sample sizes and lot sizes according the desired or required specification criteria or the process or product.
What to Expect and How to Prepare for Remote Auditing
Barbara Butrym
60 Min
Product Id: 706459
Events in the world are affecting how we do business with travel restrictions we face new uncharted waters, Companies need to maintain their certifications / suppler status and are required to be audited either by a CB or a customer periodically. To protect the client and the auditor remote auditing has been proposed as the solution. The big question is how do we prepare for a remote audit? What are some challenges and how do we address them? Some guidelines have been flowed down from Certifying Bodies to their auditors. This session will share those guidelines and help you prepare for a successful remote audit.
Patient Access of Medical Records under HIPAA - New HHS Guidance, New Focus for HIPAA Audits
Jim Sheldon-Dean
90 Min
Product Id: 705220
This training program will provide a comprehensive look at the changes in the new access rights under HIPAA and CLIA regulations and prepare attendees for the process of incorporating the changes into how they do business in their facilities. It will also explain how the HIPAA audit and enforcement activities are now being increased and what needs to be done to survive a HIPAA audit.
Medicare Annual Wellness Visits - 2021 Updates
Carol Hoppe
60 Min
Product Id: 706191
The "Welcome to Medicare" visit and Annual Wellness Visits (AWV) are important screening services available to Medicare beneficiaries at no cost. More and more practitioners are providing these services, often missing key elements to support the codes. In this session, we will look these services and discuss the typical problems providers are struggling to document when performing these visits.
Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance
Jeff Kasoff
60 Min
Product Id: 701142
This Quality management training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive Maintenance.
Guidance for Businesses and Employers to Plan and Respond to Coronavirus Disease 2019 (COVID-19)
U Harold Levy
60 Min
Product Id: 706692
This program examines what is currently known about the coronavirus disease 2019 (COVID-19). COVID-19 is a respiratory illness that can spread from person to person. This webinar provides information from the CDC, the World Health Organization and OSHA which may help prevent workplace exposures to COVID-19, in non-healthcare settings. This program also provides planning considerations for home and community spread of COVID-19.
Furthering Your Excel Knowledge using Printing, Templates, Worksheets, Conditional Formatting and Charts
Cathy Horwitz
4 Hrs
Product Id: 706691
This 4-hour course is considered intermediate level Excel Training. Learn beyond the basics of Excel.
There are many print options. Print options are found on the Page Layout ribbon. You can set margins, page orientation, and select paper size.
From Risk Control to Risk Management in Times of Pandemic
Fred Vacelet
60 Min
Product Id: 706604
Countless managers are satisfied that with a decent risk control system, no occurrence of a risk scenario is going to cost them their job, especially in times of pandemic. Where does this lead us to?
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements
John E Lincoln
90 Min
Product Id: 701898
This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.
Vendor Management for Pharmaceuticals, Biologicals, and Medical Devices
Paul Larocque
90 Min
Product Id: 706689
This webinar provides an overview of FDA’s requirements for vendor management and oversight for pharmaceuticals, biologicals, and medical devices.
2021 Evaluation and Management Changes
Carol Hoppe
90 Min
Product Id: 706687
New guidelines for office and outpatient Evaluation and Management (E/M) codes 99202-99215 were effective on January 1, 2021. This is biggest change in E/M coding and documentation since the 1995 and 1997 guidelines were published. Learn everything you need to know about documenting and coding under these new guidelines.
What Is A Sterilization Dose Audit and How Are They Performed?
Martin Byrne
60 Min
Product Id: 706688
The one-hour training discusses the major elements that should be considered prior to, during, and after the performance of a dose audit. The training is designed to instruct attendees on how to critically think about the preparation, performance, reporting, and responding to failures for a dose audit.
How to Get Results or Influence and Persuade When You Don't Have the Authority
Audrey Halpern
60 Min
Product Id: 706686
When was the last time you thought about how you influence others — how you change minds, shape opinions, move others to act? The ability to influence is one of the essential skills for leaders at all levels. It’s more art than science, and it can be tough to get your arms around. But the bottom line is that influence matters.
EU MDR 2017/745 Medical Device Classification
Juan M Campos
60 Min
Product Id: 706685
In this webinar, you will learn how to classify medical devices according to EU MDR 2017/745 Annex VIII for full compliance with new EU Medical Device Regulation mandatory starting 26-May-2021
Implementing the 2021 Guidelines for Office and Outpatient Visits
Lynn M Anderanin
60 Min
Product Id: 706576
The current guidelines for documentation of office and outpatient visits were implemented in the early 90’s and have become cumbersome and outdated for the current medical provider. For 2021 CMS and the AMA have joined together to create and implement new documentation guidelines for office and outpatient visits that must be used starting January 1, 2021.
Corrective and Preventive Action; Our Most Important Quality Process
William Levinson
90 Min
Product Id: 706684
Corrective and preventive action (CAPA) is a process of the quality management system that begins with the identification of a problem (or opportunity), goes through a series of steps including identification of the root causes and deployment and verification of a solution, and documentation and deployment of lessons learned. The deliverables include not only elimination of the problem at hand, or realization of the opportunity, but application of the best practices learned to related activities.
Risk Management for Human Resources
Greg Chartier
60 Min
Product Id: 706683
The ability to identify risks, especially emerging risks, is a critical competency of HR leaders, especially when linking it to HR’s mission of supporting better senior management decisions and more effective decision making. At the same time, organizations are most effective at dealing with regulatory compliance and less effective at dealing with the strategic aspects of risk and, most importantly, connecting risk management to strategic success. To be effective, risk management must have a broader approach, to include strategic planning risks and the risks created by daily operations. A constant in today’s corporate culture is change. With change comes an increase in risk. It is imperative that today’s HR professionals have an awareness and understanding of these risks.