ComplianceOnline

Clinical Research Trial Design and Management Regulatory Compliance Training - Live Webinars, Recordings & CDs

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training
19
/ Dec
Wednesday-2018

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

  • Speaker: Gwen Wise Blackman
  • Product ID: 705019
  • Duration: 180 Min
This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.
* Per Attendee
$299
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
Computer System Validation and Part 11 Compliance

Computer System Validation and Part 11 Compliance

  • Speaker: Joy McElroy
  • Product ID: 705427
  • Duration: 60 Min
This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.
Recorded/CD
Bioavailability and Bioequivalence Studies submitted in NDAs and INDs

Bioavailability and Bioequivalence Studies submitted in NDAs and INDs

  • Speaker: Stephanie Cooke
  • Product ID: 705506
  • Duration: 90 Min
Attendees that need to perform bioavailability (BA) and bioequivalence (BE) studies for INDs, NDAs or for NDA supplements should attend this training. They will learn the requirements of such studies, per 21 CFR 320 and all other relevant regulatory documents.
CD/Recorded
$279
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
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
Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies

Good Manufacturing Practices (GMPs) for Phase I Investigational Drugs / Clinical Studies

  • Speaker: Peggy Berry
  • Product ID: 705255
  • Duration: 90 Min
This webinar will help attendees understand differences between GMP requirements for early and later stage clinical development. It will explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.
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
Compliance with Brexit's Impact on the Global Pharmaceutical industry

Compliance with Brexit's Impact on the Global Pharmaceutical industry

  • Speaker: Laura Brown
  • Product ID: 705047
  • Duration: 60 Min
Pharmaceutical companies will need to develop strategies for their drug programmes to deal with Brexit. This webinar will provide an essential understanding to help develop a strategy for managing Brexit.
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 EU Clinical Trial Regulation

Compliance with the New EU Clinical Trial Regulation

  • Speaker: Laura Brown
  • Product ID: 705007
  • Duration: 60 Min
This webinar will provide an essential understanding to help with compliance with the new regulation and associated implementing acts and other texts for carrying out clinical trials in the EU.
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
Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

Clinical Trial auditing - Identifying risks and building a more compliant and successful trial

  • Speaker: Calin Popa
  • Product ID: 701860
  • Duration: 90 Min
Learn how to successfully pass a clinical trial audit, how to prepare for it, where and how to identify the non compliance. Know FDA inspection strategy to identify areas of common deficiency.
CD/Recorded
$249
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
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