Compliance Training Webinars for Regulated Industries

Organizations engaged in clinical research activities are exposed to risk and must develop risk mitigation strategies. This course is designed to provide attendees with strategies to mitigate the risk and develop controls to ensure a compliant clinical research billing program. Attendees will learn various control strategies and leading practice within a clinical research billing program.

Overview of Design Control for Medical Devices, with an emphasis on design inputs. Seminar will go over regulations, basic concepts in design control and importance of design inputs and how to write appropriate inputs.

This webinar uses actual case studies to look at what leads to compliance failures, and how to handle them. In each case. What were the specifics of the situation? Why was there a failure? How was it identified? What did it take to fix it? How could it have been avoided? (Lessons learned). It concludes with a summary of the evident patterns and learnings.

This webinar is intended to raise auditors’ abilities within the sphere of forensic auditing through a combination of lecture and case-study.

The financial processes supporting a clinical research study is arguably the most important aspect of the study’s life cycle. Without an understanding of clinical research finance, organizations and individuals can unknowingly violate federal regulations and subject the organization participating in clinical research activities to fines, penalties and lost of reputation. This course will provide attendee with an overview of the federal regulations and guidelines governing the financial aspect of clinical research.

Corporations are facing more risks in the expanded environment of business. This webinar will provide auditors and audit management with advanced approaches to risk management and internal risk assessment at a corporate level.

Based on lean manufacturing and documentation concepts, this webinar deconstructs the supplier quality remediation process.

Conducting a needs analysis is important since it ultimately feeds into the creation of your compliance training program. The steps you should follow can make a big impact on the program itself and, the compliance culture. In this webinar, we will go over the necessary steps and show how it impacts your compliance training program.

During this session we will discuss GDPR & California Consumer Privacy Act (release 2020). Why it’s important and also, why are stricter rules and regulations being created. Is it with the public in mind?

Send your team to this training program to help them learn how to develop the necessary skills to conduct meetings and deliver presentations. This course will explore how to overcome interruptions and handle a difficult audience. By the end of this training, their capabilities will be enhanced to handle various situations when being the center of attention in any environment.

Employee retention can help in so many ways within an organization. It could reduce risk, increase morale and improve employee capabilities. It’s important to understand who you are dealing with in your organization, that means understanding your target audience to deliver effective training. We will examine all aspects during this webinar.

Employee turnover is crazy these days in corporate America, yet different depending on who is talking. It’s not only about employers cutting back staff, it’s also about employees leaving the organization after a short period of time to pursue other opportunities. The major problem is, how do you handle training and self-leadership in an organization these days when both are an issue?

Attend this webinar to learn the key elements of running effective meetings along with the appropriate ways of enhancing your interactions and being efficient with everyone’s time.

In this webinar, learn how to find the right approach to deal with your stakeholders. Discover how to understand their core characteristics to make it easier for you to influence and persuade them.

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.

This webinar will focus on the computer systems and data that are regulated by FDA. These systems will require validation and the data must be created and maintained with integrity. We’ll cover what is required for Computer System Validation (CSV) and we’ll discuss the new draft guidance from FDA on Computer Software Assurance (CSA). We’ll also cover 21 CFR Part 11, FDA’s guidance for electronic records and electronic signatures. Finally, we’ll discuss the “ALCOA+” requirements for data integrity.

This Software Auditing Procedure training will discussion on FDA software Standard “General Principles of Software Validation”, Actual FDA investigator software auditing techniques for software failure investigations.

Substandard medications, like counterfeit drugs, present a real and increasing danger both to patients and companies and require a proactive approach to stay ahead of these problems.

This Design Control Inspection training will review of the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined.

This Webinar will describe, explain and clarify the differences between DHF, DMR and DHR . It will also detail the requirements and the expected contents of each record.