ComplianceOnline
Good Documentation Guideline (Chapter <1029> USP)
18
/ May
Tuesday-2021

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
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.
* Per Attendee
$199
Maximizing Research Billing Compliance by Leveraging System Integrations
19
/ May
Wednesday-2021

Maximizing Research Billing Compliance by Leveraging System Integrations

  • Speaker: Mary Veazie
  • Product ID: 706697
  • Duration: 120 Min
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
* Per Attendee
$249
Root Cause Analysis - The Heart of Corrective Action
26
/ May
Wednesday-2021

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
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.
* Per Attendee
$229
How to Prepare a Standard Operating Procedure (SOP)?
15
/ Jun
Tuesday-2021

How to Prepare a Standard Operating Procedure (SOP)?

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
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.
* Per Attendee
$199
Recorded/CD
Streamlining Clinical Trial Activations - Best Practice Approach

Streamlining Clinical Trial Activations - Best Practice Approach

  • Speaker: Mary Veazie
  • Product ID: 706681
  • Duration: 120 Min
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.
CD/Recorded
$349
Recorded/CD
Annual Current Good Manufacturing Practices (cGMP) Training

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
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.
CD/Recorded
$249
Recorded/CD
FDA's Ambitious Regulation of Social Media

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
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.
CD/Recorded
$279
Recorded/CD
Day 2 - Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
Recorded/CD
Day 1 - Managing GMP Compliance and Phase Appropriate GMP Considerations for Virtual Companies
Recorded/CD
Implementation and Management of GMP Data Integrity

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
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.
CD/Recorded
$299
Recorded/CD
Japan: Regulatory Compliance Requirements for Life Science Products

Japan: Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 702979
  • Duration: 90 Min
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.
CD/Recorded
$299
Recorded/CD
Clinical Study Risk Management including Compliance During The COVID-19

Clinical Study Risk Management including Compliance During The COVID-19

  • Speaker: Laura Brown
  • Product ID: 706526
  • Duration: 60 Min
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.
CD/Recorded
$399
Recorded/CD
Vendor/CRO Oversight of Clinical Trials Including Oversight Compliance During COVID-19

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

  • Speaker: Laura Brown
  • Product ID: 706527
  • Duration: 60 Min
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.
CD/Recorded
$399
Recorded/CD
Good Clinical Practice (GCP) - As Applied To The Regulated Bioanalytical Lab

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

  • Speaker: Edward O Connor
  • Product ID: 706433
  • Duration: 60 Min
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.
Recorded/CD
Applying Six Sigma Downtime to Analytical and Bioanalytical Labs

Applying Six Sigma Downtime to Analytical and Bioanalytical Labs

  • Speaker: Edward O Connor
  • Product ID: 706430
  • Duration: 60 Min
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.
CD/Recorded
$399
Recorded/CD
FDA and MHRA Guidance during the COVID-19 Emergency: Conduct of Clinical Trials

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

  • Speaker: Mark Powell
  • Product ID: 706477
  • Duration: 60 Min
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.
CD/Recorded
$399
Recorded/CD
Bioanalytical Methods Validation

Bioanalytical Methods Validation

  • Speaker: Edward O Connor
  • Product ID: 701769
  • Duration: 60 Min
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.
CD/Recorded
$299
Recorded/CD
Understanding FDA Import Alerts:  What Are They and Recommendations For Removing Your Company And Products From An Alert

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

  • Speaker: Karl M. Nobert
  • Product ID: 703313
  • Duration: 90 Min
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.
CD/Recorded
$349
Recorded/CD
Claims Processing:  Appropriate Segregation of Charges & Medical Documentation for Clinical Research Studies

Claims Processing: Appropriate Segregation of Charges & Medical Documentation for Clinical Research Studies

  • Speaker: Mary Veazie
  • Product ID: 706386
  • Duration: 90 Min
Participation in clinical research activities presents challenges for an already complex revenue cycle and insurance system. The medical documentation needed to ensure reimbursement from third party payors is an essential part of this process. This course will review the segregation process and medical documentation needed to ensure reimbursement is sufficient to obtain reimbursement from third party payors.
Recorded/CD
How Sponsors Generate GCP Noncompliance at Investigator Sites

How Sponsors Generate GCP Noncompliance at Investigator Sites

  • Speaker: Stephen Schwartz
  • Product ID: 706280
  • Duration: 90 Min
Attend this webinar to explore some of the common sponsor errors. Become aware of the risk and liability of these decisions. Learn how to get approvals of submission, prevent enforcement actions, and loss.
CD/Recorded
$299
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