Compliance Training Webinars for Regulated Industries

This webinar provides an overview of FDA’s requirements for vendor management and oversight for pharmaceuticals, biologicals, and medical devices.

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.

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.

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.

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

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for documentation of office and outpatient visits were implemented in the early 90’s and have become cumbersome and outdated for the current medical provider.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 (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.

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.

Data is important. Locating specific data is important. Being sure that the correct data is being input is critical. Thanks to Conditional Formatting, you can highlight all information that is important to you (the highest or lowest values, duplicate values, values that are larger or smaller than a certain value). This will provide you with the necessary information to make important business decisions. Conditional formatting is one of the major strengths of Excel!

This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2019 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.

This webinar will give the physician’s perspective on how documentation and medical necessity play into appropriate coding and compliance for these E/M services. How coders and auditors need to understand what certain words, phrases, orders, and clinical plans mean when a physician uses and documents them.

Activation of a clinical trial requires coordination and effective communication with several groups to be successful. Many health systems find that their trial activation times are prolonged and cumbersome. In this course, you will learn how to streamline activation times and utilize data to drive decision-making. This course provides the best practice approaches designed to create an efficient activation process.

Attend this webinar to gain a greater understanding of the arbitration process and the steps to properly prepare for arbitration through to the post-hearing brief. Also, learn what to expect and be ready to present at an arbitration hearing as well as the various alternatives to the arbitration process and how to deal with the unexpected. If it is true that “Fortune favors the prepared” and if you want to become as familiar as possible with the arbitration process and learn how to make your best possible arbitration case presentation, then this webinar is for you!

This session will discuss the requirements for Management Controls, including organizational structure, internal audits, establishment of a quality policy and confirmation it is being followed, establishment and contents of a quality system.

CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. In these companies, CAPA is a 4 letter word. This webinar will help you avoid identify the symptoms of this common problem. Learn how to avoid those struggles and establish an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA, this webinar is for you.

This presentation will provide a comprehensive overview of the successful elements of a clinical documentation improvement/integrity (CDI) program. A successful CDI program includes staffing and operational processes that have integrity and are compliance centered.

In this quality management system webinar attendees will learn the recent changes to ISO 13485:2016 standard in step by step process and how to implement these changes in their current quality management system to pass the quality management audit. Also attendees will gain knowledge on how to deal with ISO 9001 or any other quality management system in multidisciplinary quality management systems.

The webinar will discuss QC best practices and procedures for verifying the suitability and performance characteristics of microbiological media and reagents.

This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.

This webinar addresses managing GMP Complaints and Adverse Event Reports related to drug products, biologicals, and medical devices. The relevant regulations will be discussed.