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Clinical Trials Regulatory Compliance Training - Live Webinars, Recordings & CDs

/ Feb

Wednesday-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
$229

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/ Mar

Wednesday-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
$229

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Recorded/CD

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

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Recorded/CD

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

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Recorded/CD

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

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Recorded/CD

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

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Recorded/CD

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

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Recorded/CD

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

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Recorded/CD

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.

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Recorded/CD

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

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Recorded/CD

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

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Recorded/CD

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

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Recorded/CD

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.

CD/Recorded
$299

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Recorded/CD

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

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Recorded/CD

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.

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Recorded/CD

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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Recorded/CD

Leveraging Clinical Research Processes to Decrease Denials

Speaker: Mary Veazie
Product ID: 706366
Duration: 90 Min

This course will demonstrate the process of analyzing patient denials for trends related to participation in a clinical research study and leveraging this information to influence the coverage determination during Medicare Coverage Analysis (MCA) process. Participants will learn a 360 approach to increasing CRB compliance and reducing the burden to the patients participating in clinical research studies.

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Recorded/CD

Introduction to Medicare Coverage Analysis - Impact on Revenue Cycle

Speaker: Mary Veazie
Product ID: 706361
Duration: 90 Min

This course will describe the Medicare Coverage Analysis (MCA) process and the revenue cycle’s uses for this document. The course will describe the creation of the MCA and the multiple uses for this document.

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Recorded/CD

Surviving an FDA Sponsor Inspection - Training for Success

Speaker: Stephen Schwartz
Product ID: 704516
Duration: 105 Min

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.

CD/Recorded
$429

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Recorded/CD