Webinars

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.
Establishing a Medical Device Security Program

Establishing a Medical Device Security Program

In this medical devices security webinar you will learn how to establish a Product Security Program that help your organization to put the right people, processes, and technology in one place to solve the changing landscape of connected medical devices and the risks that are associated with the new environment. It will also highlight the medical device security leading best practices the industry has been implementing to not only meet regulatory requirements but also increasing customer’s needs.
Project Management for Computer Systems Validation

Project Management for Computer Systems Validation

This computer system validation training will highlight the principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show how you can use project management tenets to deliver on time and on budget, while meeting FDA regulatory compliance requirements.
Utilization and Denial Management for the Hospital Case Manager and Leader:  Medical Necessity in the World Busy Case Managers and AI

Utilization and Denial Management for the Hospital Case Manager and Leader: Medical Necessity in the World Busy Case Managers and AI

This Utilization and Denial Management webinar will assist the case management department leader and RN case manager in understanding the role of utilization management in a busy case management department. Determining the optimal model for ensuring the best approach to making sure that all cases are billed appropriately and timely is essential. This webinar will discuss two models, as well as the new concept of artificial intelligence that can be utilized as an adjunct to the medical necessity process.
CDISC Mapping 1: Specifications and FDA Requirements

CDISC Mapping 1: Specifications and FDA Requirements

This training program will discuss CDISC requirements to create SDTMs and ADaMs. It will also offer essential mapping and strategy concepts for creating and validating SDTM and ADaM variables in key CDISC datasets (DM, AE, ADSL, and ADAE).
FDA Compliance and Clinical Trial Computer System Validation

FDA Compliance and Clinical Trial Computer System Validation

This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.
Grievances and Complaints: What Hospitals Should Know about the CMS, Joint Commission, DNV and OCR Standards?

Grievances and Complaints: What Hospitals Should Know about the CMS, Joint Commission, DNV and OCR Standards?

This training program will discuss in detail the CMS requirements for hospitals to help prevent the hospital from being found out of compliance with the grievance regulations. It will also cover a new law under the OCR Section 1557 which requires the hospital to have a new process for handling discrimination complaints.
Prevention of Infection in Healthcare Workers

Prevention of Infection in Healthcare Workers

For healthcare facilities and long-term care facilities looking to promote employee safety in the workplace, this webinar will provide essential information on structuring your employee health program as per Center of Disease Control (CDC), Occupational Health and Safety Administration (OSHA), Centers for Medicare and Medicaid Services (CMS), and the National Institute for Occupational Safety and Health (NIOSH) recommendations.
Current Concepts and Challenges in Cloud Compliance

Current Concepts and Challenges in Cloud Compliance

Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
FDA Regulations for Environmental Monitoring (EM) Program

FDA Regulations for Environmental Monitoring (EM) Program

This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
Medical Device Employee Training - Requirements and Implementation Tips

Medical Device Employee Training - Requirements and Implementation Tips

This webinar will review types of training requirements from the FDA and ISO 13485 for medical device employee. It will discuss techniques for monitoring and documenting training effectiveness.
Bundled Payment Review: How Case Management Can Play a Strategic Role

Bundled Payment Review: How Case Management Can Play a Strategic Role

This webinar will teach you how bundled payments actually work as they move from demonstration to reality. It will discuss how case management must become a fully integrated, across the continuum model
Introduction to Root Cause Investigation for CAPA

Introduction to Root Cause Investigation for CAPA

This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
Confidence/Reliability Calculations of Process and Product Capability

Confidence/Reliability Calculations of Process and Product Capability

In this webinar attendees will learn the specific easy-to-use formulas for calculating what % a population or process is "in-specification" (= % Reliability). This webinar focuses on explaining which formulas to use for what type of data, and when/how to perform transformations to normality prior to using such formulas.
Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

Pharmacokinetics/Biopharmaceutics for Chemists/Analysts

This training program will focus on defining and explaining numerous concepts and terminologies in a simple language as related to the safety, efficacy and quality assessment of pharmaceutical products for human use. It will also describe the necessity of understanding the basic physiological concepts pertinent to drug actions, product developments and evaluations.

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