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Home › Online Training ›  Clinical Training

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

Sub Categories: Risk Management | Audits & Inspections | GCP & Other Best Practices | Outsourcing | Trial Design and Management | Ethics, Fraud and Misconduct | Patient Recruitment | Regulations & Guidances | Documentation and Data Management | Roles and Responsibilities
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Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert
23
/ Apr
Thursday-2020

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.
* Per Attendee
$249
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Root Cause Analysis - The Heart of Corrective Action
23
/ Apr
Thursday-2020

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
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Bioanalytical Methods Validation
29
/ Apr
Wednesday-2020

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.
* Per Attendee
$229
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Applying Six Sigma Downtime to Analytical and Bioanalytical Labs
28
/ May
Thursday-2020

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.
* Per Attendee
$229
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FDA's Ambitious Regulation of Social Media
16
/ Jun
Tuesday-2020

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.
* Per Attendee
$229
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Implementation and Management of GMP Data Integrity
18
/ Jun
Thursday-2020

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.
* Per Attendee
$249
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Good Clinical Practice (GCP) - As Applied To The Regulated Bioanalytical Lab
24
/ Jun
Wednesday-2020

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.
* Per Attendee
$229
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Recorded/CD
How to Prepare a Standard Operating Procedure (SOP)?

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.
CD/Recorded
$299
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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.
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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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Recorded/CD
Leveraging Clinical Research Processes to Decrease Denials

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

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

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
How to Write Technical Papers

How to Write Technical Papers

  • Speaker: Gholamreza Zahedi
  • Product ID: 706335
  • Duration: 60 Min
This webinar will cover how to write a paper. Guidelines on framing a paper, journal selection and tips for publishable paper will be provided.
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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
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Recorded/CD
Statistical Elements of Real-Time qPCR

Statistical Elements of Real-Time qPCR

  • Speaker: Elaine Eisenbeisz
  • Product ID: 706274
  • Duration: 120 Min
Join Elaine Eisenbeisz as she shows you how to use data to estimate a standard curve, how to perform computations for absolute and relative quantification. She will also present a few decision-making criteria and statistical tests that can be used with qPCR data.
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Recorded/CD
Good Documentation Guideline (Chapter <1029> USP)

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.
CD/Recorded
$299
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Recorded/CD
Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan

  • Speaker: Robert J Russell
  • Product ID: 705370
  • Duration: 90 Min
This webinar will focus on the key regulatory requirements for medical devices for the participating MDSAP countries of U.S., Canada, Brazil, Australia and Japan. It will address key topics such as device classification, licensing pathways, medical device GMP, inspections, device labeling, license holder responsibilities and more.
CD/Recorded
$299
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Recorded/CD
Medical Foods: Clinical Research and Product Development Opportunities

Medical Foods: Clinical Research and Product Development Opportunities

  • Speaker: Alan S Ryan
  • Product ID: 706279
  • Duration: 90 Min
The emerging medical foods market in the United States is $1.3 billion annually with strong growth potential. As a distinct, FDA-regulated category, medical foods are gaining more widespread acceptance. However, they remain poorly understood by patients, pharmacists and physicians. This webinar will describe the regulatory pathway for approval, the definition of a medical food, examples of medical foods, and product development opportunities.
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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
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