ComplianceOnline

Research and Development Training - Live Webinars, Recordings & CDs

ComplianceOnline's training programs for Research and Development professionals are designed to stimulate and manage innovation in the workplace. Improve the productivity of your R&D and foster excellence by learning concepts, methodologies, and the use of tools to strategically plan product development and to manage core competencies. Explore the courses developed by a multitude of experts for diverse, creative, intelligent, and independent R&D professionals.

Recorded/CD
Viral Validation for Biopharmaceuticals

Viral Validation for Biopharmaceuticals

  • Speaker: Kathryn Martin Remington
  • Product ID: 700187
  • Duration: 60 Min
This Viral Validation webinar provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation.
CD/Recorded
$249
Recorded/CD
Risk Management Activities during Design Input

Risk Management Activities during Design Input

  • Speaker: Edwin L Bills
  • Product ID: 700526
  • Duration: 60 Min
Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation. Risk Management Activities can lead to reduced cost and reduced time to market when conducted during the Design Input phase of product development. Learn how to use tools such as Preliminary Hazard Analysis to eliminate expensive design changes that occur when problems are discovered during Design Verification and Design Validation.
CD/Recorded
$149
Recorded/CD
Common Problems and Mistakes in Method Validation in drug development process

Common Problems and Mistakes in Method Validation in drug development process

  • Speaker: Dr. Wise Blackman
  • Product ID: 700267
  • Duration: 60 Min
This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. This web seminar will address frequently observed issues and problems with method validations.
CD/Recorded
$0
Recorded/CD
How to set up a small-volume radiopharmaceuticals manufacturing facility

How to set up a small-volume radiopharmaceuticals manufacturing facility

  • Speaker: Shankar Seetharaman
  • Product ID: 700475
  • Duration: 60 Min
This Radiopharmaceuticals training will set out guidance and advice for those interested in setting up or improving an existing facility. Radiopharmaceutical manufacture is starting to begin a new phase as FDG now has a product licence
CD/Recorded
$249
Recorded/CD
Bringing FDA Pharmaceutical GMPs into the 21st Century

Bringing FDA Pharmaceutical GMPs into the 21st Century

  • Speaker: Tony Dunbar
  • Product ID: 700346
  • Duration: 60 Min
This Pharmaceutical training will review the key aspects of Pharmaceutical GMPs for the 21st Century and Quality Systems Approach to Pharmaceutical CGMP Regulations.
CD/Recorded
$129
Recorded/CD
Outsourcing analytical and pharmaceutical development

Outsourcing analytical and pharmaceutical development

  • Speaker: Michael Gamlen
  • Product ID: 700231
  • Duration: 60 Min
This webinar is targeted at people responsible for outsourcing, and at contractors who wish to ensure they provide excellent services which will generate them repeat business.
CD/Recorded
$0
Recorded/CD
CGMPs for Investigational Drugs and Biologics

CGMPs for Investigational Drugs and Biologics

  • Speaker: Barbara Immel
  • Product ID: 700234
  • Duration: 60 Min
The European Union has stated their requirements in Annex 13, while FDA has recently issued a controversial new phase 1 guidance Join us for a discussion of actual requirements, and both historic and current guidance document recommendations
CD/Recorded
$299
Recorded/CD
Design Input: How to write requirements and modularize a product

Design Input: How to write requirements and modularize a product

  • Speaker: Richelle Helman
  • Product ID: 700223
  • Duration: 60 Min
In this design Input training we will define design input, review robust requirements development, assess the impact of user needs vs. patient needs and discuss options for timing your design reviews.
CD/Recorded
$99
Recorded/CD
Development Planning: How to Structure, Write, and Effective

Development Planning: How to Structure, Write, and Effective

  • Speaker: Richelle Helman
  • Product ID: 700190
  • Duration: 60 Min
This Training will identify and review the key planning documents, including team assignments, management and conduct of the project, project phases, and regulatory requirements and scheduling.
CD/Recorded
$249
Recorded/CD
Implementing Clinical Trial Performance Metrics

Implementing Clinical Trial Performance Metrics

  • Speaker: Dr. Carla Hagelberg
  • Product ID: 700182
  • Duration: 60 Min
This Clinical Trial training will helps in implementing Metrics that can be used as clinical trial performance improvement indicators.
CD/Recorded
$149
Recorded/CD
Using Risk Analysis to Optimize Product Development and Manufacturing

Using Risk Analysis to Optimize Product Development and Manufacturing

  • Speaker: Robert DiNitto
  • Product ID: 700166
  • Duration: 60 Min
This Risk Analysis training guide you through the methodologies of and distinctions between Hazard Analyses, dFMEAs, and pFMEAs and step beyond performing Risk Analyses and documenting mitigations to the practical and proactive application. Did you know that you can use your existing Risk Analyses to help you do more than manage risk? Risk Analyses can be used to prioritize and streamline Design Input, Design Output, Design V&V, and both Pre-Production.
CD/Recorded
$249
Recorded/CD
4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs

  • Speaker: Nanda Subbarao
  • Product ID: 704730
  • Duration:
This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.
CD/Recorded
$0
Recorded/CD
Stability Program for Pharmaceuticals and Biologics

Stability Program for Pharmaceuticals and Biologics

  • Speaker: Nanda Subbarao
  • Product ID: 705455
  • Duration:
This webinar will provide an overview of the stability studies required for pharmaceuticals and biologics. It will also provide a summary of recent developments in the industry and regulatory requirements in this field.
CD/Recorded
$0
Recorded/CD
Establish an Effective Change Management Process for Stability Studies

Establish an Effective Change Management Process for Stability Studies

  • Speaker: Kim Huynh-Ba
  • Product ID: 704085
  • Duration:
Upon completion of this training program, attendees will learn key elements of a change management process, identify key indicators of change and learn the regulatory requirements for change control. This session will also discuss different observations due to the lack of effective change control program.
CD/Recorded
$0
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