ComplianceOnline

FDA Good Clinical Practice Regulatory Compliance Training - Live Webinars, Recordings & CDs

Surviving an FDA Sponsor Inspection - Training for Success
19
/ Feb
Tuesday-2019

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
$199
Recorded/CD
Extractables and Leachables in Early Phase Development

Extractables and Leachables in Early Phase Development

  • Speaker: Wayland Rushing
  • Product ID: 704517
  • Duration: 60 Min
This training program will offer insight into where extractables and leachables come from. Attendees will learn the regulatory expectations and trends for extractables and leachables in early phase development and learn which products may require E&L data in early phases. The program will also focus on how to design programs to meet the needs of early phase development – i.e. phase appropriate E&L programs.
CD/Recorded
$279
Recorded/CD
Preparing Compliant eCTD Submissions:  Are You Prepared for Upcoming FDA Mandate on e-Submissions?

Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

  • Speaker: Peggy Berry
  • Product ID: 705349
  • Duration: 60 Min
This webinar will review the CTD format requirements including documentation and technical requirements for an eCTD submissions. It will help attendees prepare for implementing the FDA upcoming mandates on e-submissions.
CD/Recorded
$10
Recorded/CD
How to undergo an FDA Inspection Successfully

How to undergo an FDA Inspection Successfully

  • Speaker: Marie Morin
  • Product ID: 705170
  • Duration: 90 Min
This webinar will discuss best practices for preparing for an international announced inspection as well as how to be always prepared for those in the US who may be inspected at any time. It also discusses the various roles of the persons who will be assisting during the inspection and suggests how to organize support personnel to aid in keeping the inspection going smoothly and identify and address issues before FDA sees them.
CD/Recorded
$249
Recorded/CD
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance

Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance

  • Speaker: Sarah Fowler Dixon
  • Product ID: 705451
  • Duration: 60 Min
This webinar will provide an understanding of the data integrity and data lifecycle within the GxP environment. Attendees will learn best practices to comply with the current regulations and industry standards for electronic data integrity throughout the data lifecycle.
Recorded/CD
Issues related to informed consent in clinical trials

Issues related to informed consent in clinical trials

  • Speaker: Sarah Fowler Dixon
  • Product ID: 705453
  • Duration: 60 Min
This webinar will discuss some common literacy trends, issues with consent documents and tips to enhance the consent process.
Recorded/CD
Trial Master File and Clinical Data Management Regulated by FDA

Trial Master File and Clinical Data Management Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 705360
  • Duration: 60 Min
This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.
CD/Recorded
$249
Recorded/CD
Annual Current Good Clinical Practices (cGCP) Training

Annual Current Good Clinical Practices (cGCP) Training

  • Speaker: Shana Dressel
  • Product ID: 705408
  • Duration: 60 Min
This webinar will cover background information and history of clinical research and drug development, followed by review of the federal regulations, International Council for Harmonisation (ICH), and Good Clinical Practices (GCP) that apply to clinical research.
CD/Recorded
$249
Recorded/CD
Risk Based Monitoring for GCP Compliance

Risk Based Monitoring for GCP Compliance

  • Speaker: Laura Brown
  • Product ID: 705052
  • Duration: 60 Min
This Webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies.
CD/Recorded
$249
Recorded/CD
How to prepare a winning Standard Operating Procedure (SOP)

How to prepare a winning 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.
Recorded/CD
Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

Use of Electronic Health Record Data (EHR) in FDA regulated clinical investigations

  • Speaker: Rachelle D Souza
  • Product ID: 704906
  • Duration: 60 Min
This webinar will discuss FDA’s current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination products.
CD/Recorded
$249
Recorded/CD
Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?

  • Speaker: Charles H Pierce
  • Product ID: 704842
  • Duration: 90 Min
This webinar will discuss the expectations of Phase 1 'First-in-Man' clinical studies, contrast the testing of pharmacokinetics and pharmacodynamics, differentiate safety testing in Phase 1 and 3 and describe the process of establishing the starting dose.
CD/Recorded
$25
Recorded/CD
Compliance with the New ICH GCP revised 2 Guidelines

Compliance with the New ICH GCP revised 2 Guidelines

  • Speaker: Laura Brown
  • Product ID: 704989
  • Duration: 60 Min
This New ICH GCP E6 Revision 2 changes will cover those new requirements for running clinical trials, evaluate the changes and discuss how to implement these for sponsors, CROs and study sites. This session will enable you to meet the new international GCP standard to ensure the acceptance of clinical trial data by the regulatory authorities internationally including the European Union (EU), Japan, the United States, Canada and Switzerland.
Recorded/CD
Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

  • Speaker: Jennifer Holcomb
  • Product ID: 702406
  • Duration: 60 Min
This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations.
CD/Recorded
$249
Recorded/CD
Defining and Managing Protocol Deviation/Violation/Exception

Defining and Managing Protocol Deviation/Violation/Exception

  • Speaker: Calin Popa
  • Product ID: 704953
  • Duration: 90 Min
This webinar will teach you how to downsize the risk of noncompliance during the development of a clinical trial by helping you to understand, correct and prevent potential protocol deviations/violations.
Recorded/CD
Budgeting for Clinical Trials: Costs of a Study and Which Costs Sponsors are Responsible to Cover

Budgeting for Clinical Trials: Costs of a Study and Which Costs Sponsors are Responsible to Cover

  • Speaker: Jennifer Holcomb
  • Product ID: 702332
  • Duration: 60 Min
This 60-minute webinar will help you understand what the true costs are for completing a clinical study and the unanticipated costs that may arise. You will learn about costs that a sponsor must include in a budget and costs that a site bears in the conduct of clinical research.
CD/Recorded
$229
Recorded/CD
Creating Effective SOPs for Regulatory Compliance

Creating Effective SOPs for Regulatory Compliance

  • Speaker: Henry Urbach
  • Product ID: 702999
  • Duration: 60 Min
This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).
CD/Recorded
$279
Recorded/CD
The New EU Clinical Trial Regulation

The New EU Clinical Trial Regulation

  • Speaker: Robert J Russell
  • Product ID: 703758
  • Duration: 90 Min
This course will present attendees with a clear understanding of the new processes and requirements for EU sponsors of clinical trials as the new regulation is published, rolled-out and implemented by the Member States, the European Medicines Agency and the European Commission.
CD/Recorded
$279
Recorded/CD
Investigational Review Board and FDA Warning Letters

Investigational Review Board and FDA Warning Letters

  • Speaker: Kesley Tyson
  • Product ID: 704786
  • Duration: 60 Min
This training program will identify regulations and guidelines pertaining to institutional review boards. Attendees will learn about the historical events leading up to today’s regulatory framework in clinical research as well as discuss recent ethical issues regarding the IRB. The course will also explore the emergence of IRBs that are not academically affiliated.
Recorded/CD
Data Management in Clinical Research

Data Management in Clinical Research

  • Speaker: Kesley Tyson
  • Product ID: 704768
  • Duration: 60 Min
This training program will identify regulations and guidelines pertaining to data management in clinical research. Attendees will learn to translate the regulations and guidelines into practical application for each stage of the clinical trial: start-up, ongoing study management, and study closure. The program will also discuss the do’s/don’t for data management activities through real-life examples.
Best Sellers
You Recently Viewed
    Loading