Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705130

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

15 / Feb / 2022 - Tuesday

* Per Attendee $249

 

How to Prepare a Standard Operating Procedure (SOP)?

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705131

This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.

8 / Mar / 2022 - Tuesday

* Per Attendee $199

 

Risk Mitigation Strategies for Clinical Research Finance

webinar-speaker   Mary Veazie

webinar-time   120 Min

Product Id: 706788

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.

10 / Mar / 2022 - Thursday

* Per Attendee $249

 

FDA's Ambitious Regulation of Social Media

webinar-speaker   Casper Uldriks

webinar-time   60 Min

Product Id: 703853

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.

15 / Mar / 2022 - Tuesday

* Per Attendee $229

 

Incorporating Denials Management into Clinical Research Billing

webinar-speaker   Mary Veazie

webinar-time   120 Min

Product Id: 706795

Data is an organization’s biggest asset. For clinical research billing programs, an organization’s revenue data can be a vital resource to strengthen controls and mitigate risk. This course will focus on leveraging denials data to strengthen the coverage analysis development and an organization’s clinical research billing program. You will learn to utilize the rich data in an organization’s clinical research revenue cycle to strength controls and mitigate risk.

24 / Mar / 2022 - Thursday

* Per Attendee $249

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

Recording Available

* Per Attendee $249

 

Overview of the Financial Aspects of Clinical Research

webinar-speaker   Mary Veazie

webinar-time   120 Min

Product Id: 706778

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.

Recording Available

 

Clinical Research Revenue Cycle: Bridging Health Systems and Clinical Research

webinar-speaker   Mary Veazie

webinar-time   120 Min

Product Id: 706775

Clinical research revenue cycle (CRRC) is an integral part of a clinical research portfolio. It is a complex environment that bridges a health systems revenue cycle with clinical research activities. Health systems involved in clinical research activities struggle with effectively incorporating these two environments. In this course, attendees will learn framework for an effective and compliant CRRC program.

Recording Available

 

Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense

webinar-speaker   Elaine Eisenbeisz

webinar-time   90 Min

Product Id: 703552

This clinical research webinar will explore the reasoning that formulates null hypotheses and turns researchers’ hair gray. Attendees will learn the why and how of the scientific method and how to view the world with a statistician’s eyes. Also attendees will learn the possibilities and limitations of research questions and hypothesis development, how to interpret statistical findings with p-values, effect sizes, and confidence intervals.

Recording Available

* Per Attendee $349

 

Root Cause Analysis - The Heart of Corrective Action

webinar-speaker   Betty Lane

webinar-time   75 Min

Product Id: 703391

This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.

Recording Available

* Per Attendee $299

 

Requirements for Running Clinical Trials in Pediatrics for the EU

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 701983

This training will cover compliance requirements for running clinical trials in pediatrics, particularly in the EU to comply with the EU ethical considerations guidance for running clinical trials in pediatrics.

Recording Available

* Per Attendee $299

 

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

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 701947

This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance.

Recording Available

* Per Attendee $299

 

Developing Staffing Models for Clinical Research Finance Structure

webinar-speaker   Mary Veazie

webinar-time   120 Min

Product Id: 706707

A key component of building a clinical research finance team is creating a staffing model that will support the health system’s clinical research portfolio. This course focuses on key metrics and KPIs to help attendees develop a staffing model for their organization.

Recording Available

 

Maximizing Research Billing Compliance by Leveraging System Integrations

webinar-speaker   Mary Veazie

webinar-time   120 Min

Product Id: 706697

Research Billing is complex and often manual process for many health systems. Attendees will learn how system integrations can improve the quality of a health care system’s compliance program

Recording Available

* Per Attendee $349

 

 

 

Streamlining Clinical Trial Activations - Best Practice Approach

webinar-speaker   Mary Veazie

webinar-time   120 Min

Product Id: 706681

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.

Recording Available

* Per Attendee $349

 

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Recording Available

* Per Attendee $299

 

Japan: Regulatory Compliance Requirements for Life Science Products

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702979

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.

Recording Available

* Per Attendee $299

 

Clinical Study Risk Management including Compliance During The COVID-19

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 706526

Attend this webinar to understand the key requirements for risk management of clinical trials to comply with the latest focus on GCP inspection in this area including during the challenging environment of COVID-19.

Recording Available

* Per Attendee $399

 

 

 

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