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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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Statistical Elements of Real-Time qPCR
29
/ Jan
Wednesday-2020

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.
* Per Attendee
$299
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How to Write Technical Papers
19
/ Feb
Wednesday-2020

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.
* Per Attendee
$229
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Japan: Regulatory Compliance Requirements for Life Science Products
19
/ Feb
Wednesday-2020

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.
* Per Attendee
$249
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Surviving an FDA Sponsor Inspection - Training for Success
20
/ Feb
Thursday-2020

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.
* Per Attendee
$249
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Introduction to Medicare Coverage Analysis - Impact on Revenue Cycle
24
/ Feb
Monday-2020

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.
* Per Attendee
$249
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Leveraging Clinical Research Processes to Decrease Denials
9
/ Mar
Monday-2020

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.
* Per Attendee
$249
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How Sponsors Generate GCP Noncompliance at Investigator Sites
12
/ Mar
Thursday-2020

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.
* Per Attendee
$249
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How to Prepare a Standard Operating Procedure (SOP)?
27
/ Mar
Friday-2020

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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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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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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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
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Recorded/CD
Good Clinical Practice R2 addendum only

Good Clinical Practice R2 addendum only

  • Speaker: Linda Hopkinson
  • Product ID: 706088
  • Duration: 90 Min
This webinar will provide you with a recap into what is Good Clinical Practice (GCP) and help you understand why the Revision 2 addendum was required. It will allow you to understand the implications of this revision for clinical research trials and gain the knowledge to fully comply with ICH GCP. It will provide an overview of what additions were added in the R2 addendum.
CD/Recorded
$399
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Recorded/CD
Financial Management of Clinical Research: Developing Data Analytics to Drive Decision Making

Financial Management of Clinical Research: Developing Data Analytics to Drive Decision Making

  • Speaker: Mary Veazie
  • Product ID: 706215
  • Duration: 90 Min
Data is key to decision making. This webinar will equip participants with knowledge, tools and resources to develop meaningful financial metrics to drive decision making. Key financial performance indicators for managing clinical research portfolios will be provided.
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Recorded/CD
Root Cause Analysis - The Heart of Corrective Action

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
Effective Time Management in Clinical Trials

Effective Time Management in Clinical Trials

  • Speaker: Barbara Randall
  • Product ID: 706161
  • Duration: 60 Min
Attend this webinar to learn how to shorten the timeline for key deliverables such as case report form Design, database build, and duration between last patient out and database lock without negatively impacting data quality or putting data integrity at risk.It will cover useful tips and guidance about the activities that may be streamlined without reducing quality and budget considerations. The webinar will cover warnings about quality steps that should not be eliminated or short-changed in a rush to get done faster.
CD/Recorded
$299
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Recorded/CD
Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense

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

  • Speaker: Elaine Eisenbeisz
  • Product ID: 703552
  • Duration: 120 Min
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.
CD/Recorded
$349
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Recorded/CD
Management of the Data Safety Management Committee for Clinical Trials

Management of the Data Safety Management Committee for Clinical Trials

  • Speaker: Yashar Salek
  • Product ID: 706133
  • Duration: 60 Min
Join this webinar to receive instructions on the uses of, need for, setup of, and management of a Data Safety Management Committee for an FDA regulated clinical trial.
CD/Recorded
$299
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