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Home › Online Training ›Clinical Training ›  Regulations & Guidances

Clinical Research Regulations and Guidance Training - Live Webinars, Recordings & CDs

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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
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Current Concepts and Challenges in Cloud Compliance
7
/ Jan
Monday-2019

Current Concepts and Challenges in Cloud Compliance

  • Speaker: Angela Bazigos
  • Product ID: 703739
  • Duration: 90 Min
Cloud computing has become perhaps the most critical compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantee that management will expect compliance strategies to be developed that will support decisions to utilize cloud environments to perform regulated activities. This presentation will provide a baseline of information related to cloud computing which will help attendees better understand the cloud concept, associated regulatory challenges, and suggestions for consideration when establishing a cloud based system.
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Data Governance for Computer Systems Regulated by FDA
23
/ Jan
Wednesday-2019

Data Governance for Computer Systems Regulated by FDA

  • Speaker: Carolyn Troiano
  • Product ID: 704745
  • Duration: 60 Min
In this webinar attendees will learn about FDA’s regulatory expectations for classifying, assessing the risk, testing, and validating a computer system used in FDA-regulated work. Also attendees will learn in detail about the System Development Life Cycle (SDLC) methodology used to approach Computer System Validation (CSV), including all of the phases, sequencing of events, deliverables, and documentation requirements.
* Per Attendee
$199
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Medical Device Single Audit Program [MDSAP] Implementation & Participating Country Regulatory Processes: U.S., Canada, Brazil, Australia and Japan
30
/ Jan
Wednesday-2019

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.
* Per Attendee
$199
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FDA Compliance and Clinical Trial Computer System Validation
27
/ Feb
Wednesday-2019

FDA Compliance and Clinical Trial Computer System Validation

  • Speaker: Carolyn Troiano
  • Product ID: 705358
  • Duration: 60 Min
This webinar will discuss FDA requirements for clinical trial Computer System Validation (CSV) including System Development Life Cycle (SDLC) approach to validation. It will help attendees understand how to leverage the vendor and other external resources to apply the best industry practices and avoid potential pitfalls when validating a clinical trial system.
* Per Attendee
$199
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Recorded/CD
Validation and Use of Cloud Computing in FDA Regulated Environments

Validation and Use of Cloud Computing in FDA Regulated Environments

  • Speaker: Dr. Ludwig Huber
  • Product ID: 703423
  • Duration: 75 Min
This webinar will discuss FDA requirements related to cloud computing. It will provide step-by-step recommendations for using 'clouds' from planning to reporting.
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
Implementation and Management of GMP Data Integrity

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both. To assure the quality of raw materials, in process materials and finished goods, laboratory data integrity is assuming greater importance in CGMP for US FDA regulated industry. Data integrity and security infractions are not only 21 CFR Part 11 issues but also severe CGMP violations.
CD/Recorded
$249
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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
$249
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Recorded/CD
How to Transition from Paper to Electronic Records in a Regulatory Environment

How to Transition from Paper to Electronic Records in a Regulatory Environment

  • Speaker: Charlie Sodano
  • Product ID: 703576
  • Duration: 75 Min
This webinar will cover effective and efficient ways to transition from paper to electronic records in a regulated environment. It will address compliance issues, complexity in decision making and implications specific to the pharmaceutical industry.
CD/Recorded
$249
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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
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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
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Recorded/CD
Building a Vendor Qualification Program for FDA Regulated Industries

Building a Vendor Qualification Program for FDA Regulated Industries

  • Speaker: Jonathan M Lewis
  • Product ID: 703467
  • Duration: 60 Min
This webinar will teach attendees best practices for building a sustainable vendor qualification program for FDA regulated industries. It will discuss common pitfalls to avoid when qualifying vendors.
CD/Recorded
$249
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Recorded/CD
Environmental Monitoring (EM) Program Basics

Environmental Monitoring (EM) Program Basics

  • Speaker: Joy McElroy
  • Product ID: 704377
  • Duration: 60 Min
This training program on applicable regulations pertaining to clean room environmental monitoring (EM) programs will discuss the basics of setting a robust and effective EM program. The course will also detail the relationship between an EM Excursion Program and CAPA and the four phases of clean room transitional monitoring.
CD/Recorded
$249
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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.
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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
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Recorded/CD
How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

How to Select and Manage Vendors in a Regulated Environment (incl. ICH E6)

  • Speaker: Angela Bazigos
  • Product ID: 705488
  • Duration: 90 Min
Buying software is a fact of life for most companies. There is fierce competition in the market, with multiple software vendors trying to convince to buy their product. How do you determine whether to buy the software or having it built in house? Or which vendor to choose? And if you buy something, how do you determine whether to have it hosted? And are there any regulations that apply to this software? And if so, what are they?
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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.
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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: 60 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
$249
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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.
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