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
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
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

  • Speaker: Kenneth Christie
  • Product ID: 703635
  • Duration:
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
CD/Recorded
$0
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
Recorded/CD
Establish Change Control for Pharmaceutical Stability Program

Establish Change Control for Pharmaceutical Stability Program

  • Speaker: Kim Huynh-Ba
  • Product ID: 702968
  • Duration:
This webinar on pharmaceutical stability program will discuss the types of CMC changes in the life cycle of a pharmaceutical product and how it affects the stability program.
CD/Recorded
$0
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