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.

23 / Jul / 2021 - Friday

* Per Attendee $199

 

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.

17 / Aug / 2021 - Tuesday

* Per Attendee $229

 

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

 

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.

Recording Available

* Per Attendee $299

 

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

 

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

 

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.

Recording Available

* Per Attendee $299

 

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

 

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

 

 

 

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

 

Vendor/CRO Oversight of Clinical Trials Including Oversight Compliance During COVID-19

webinar-speaker   Laura Brown

webinar-time   60 Min

Product Id: 706527

This webinar covers the key requirements for CRO oversight compliance with the latest focus on GCP inspection in this area including during the challenging environment of COVID-19.

Recording Available

* Per Attendee $399

 

Good Clinical Practice (GCP) - As Applied To The Regulated Bioanalytical Lab

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 706433

Analysis of samples supporting a clinical trial requires familiarity with the clinical protocol, at least at the sample management and bioanalytical PI level. This understanding improves lab efficiency and regulatory and legal compliance.

Recording Available

 

Applying Six Sigma Downtime to Analytical and Bioanalytical Labs

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 706430

Applying Six Sigma techniques to laboratory practices increases efficiency, decreases waste and improves morale. This presentation will demonstrate how applying DOWNTIME can help improve the efficiency of lab service and function.

Recording Available

* Per Attendee $399

 

FDA and MHRA Guidance during the COVID-19 Emergency: Conduct of Clinical Trials

webinar-speaker   Mark Powell

webinar-time   60 Min

Product Id: 706477

The current coronavirus pandemic has created problems for the management of ongoing clinical trials. In response, regulators have produced guidance aimed at protecting the safety of subjects and clinical trial integrity. This webinar sets out how the US FDA and UK MHRA expect those involved in the management of clinical trials to address these problems.

Recording Available

* Per Attendee $399

 

Bioanalytical Methods Validation

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 701769

This training on bio-analytical methods validation will help you to understand the FDA and EMA guidance for Instrumental, ligand binding and cell-based assays and also review of recent 483s impacting validation.

Recording Available

* Per Attendee $299

 

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

webinar-speaker   Karl M. Nobert

webinar-time   90 Min

Product Id: 703313

This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.

Recording Available

* Per Attendee $349

 

 

 

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