Development Process Web-based Seminars

Challenges that must be Considered When First-in-Human and Subsequent Phase I studies are Contemplated - Webinar By GlobalCompli This Webinar goes over the scientific standards of the First-in-Human ("first-in-Man" / FIM) studies and other Phase I studies in the drug development process. The FiM and other Phase I studies set the tone of all future Pre NDA studies. Tuesday, March 6, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Drug Development Process - From Discovery to Marketing - Webinar By GlobalCompliancePanel This webinar will provide a clinical and regulatory perspectives on requirements to take a new drug from research to market. Wednesday, February 15, 2012 10: 00 AM PST | 01: 00 PM EST  more...

Why is Drug Induced Liver Injury an Important Mirror of Drug Safety and How to Spot this early - Webinar By mentorhealth Ferreting out which Investigational Medicinal Products (IMP) might cause significant liver injury is not an easy process partly because there is confusion about how to test for liver injury and part because these AEs are rare (in the 1: 10, 000+ area) or "idiosyncratic" in type so are not picked up in the usual drug development process testing. Wednesday, November 30, 2011 10: 00 AM PST | 01:  more...

The Drug Development Process - From RD to Commercialization - Webinar By GlobalCompliancePanel In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must collaborate extensively to design, develop, manufacture, test, validate and commercialize new drugs. Successful commercialization depends on effective processes to bring both the drug supply manufacturing processes and controls as well as the associated data and  more...

Failure Mode Effects Analysis FMEA - The Tool of Choice to Improve Product and Process Reliability and Efficiency While Reducin Failure Mode and Effects Analysis is a tried an proven technique to improve the quality, reliability and safety of products and processes in a proactive manner. It has been used successfully for over 60 years in very type of industry and in all stages of product development, process improvement projects. It helps to increase customer satisfaction, by proactively addressing failures that keep us  more...

The GCPICH Obligations of Sponsors Monitors and Investigators - barriers and solution - Webinar By GlobalCompliancePanel ...sors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the ICH processes and why the Sponsora ™s / CROa ™s Monitors are so important. Areas Covered in the Session: * The historical background of why the GCP standards were developed *  more...

FDA Clinical Trial Auditing and the due diligence Companies should conduct as part of their monitoring program - Webinar By GCP ...sors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the FDA processes and why the Sponsor's / CRO's Monitors are so important. Areas Covered in the Session: * What doe the FDA look at when Auditing/ Inspecting a study? * The Sponsor's  more...

The Use and Mis-use of FMEA in Medical Device Risk Management - Webinar By GlobalCompliancePanel ...hazard analysis) but a FMEA conducted late in the product development process is largely a documentation exercise - rarely does this FMEA affect the design. Emphasis is placed on enhancing the power and benefits of FMEA for your organization by avoiding common pitfalls and concentrating efforts toward the real value of the FMEA process. Areas Covered in the Session: * What is an FMEA  more...

Project Management in a cGMP Environment - Webinar By GlobalCompliancePanel ...e tools to bring predictability to your company's product development process. Use them to defend your remediation efforts with the FDA. Use them to prove "progress against plan". Areas Covered in the Session: * Why formal Project Management * The three most common tools * How to compile * Gantt, CPM, PERT * Simple construction techniques * Work breakdown  more...

The Drug Development Path - From RD to Commercialization - Webinar By GlobalCompliancePanel ...development process, reviewing key deliverables for each stage of the development path with a special focus on managing the development process when using external resources such as Contract Manufactures, Contract Testing Labs and Contract Research Organizations. In today's fast-paced, highly regulated and risk-aversive environment, functional groups can no longer work in isolation, but must  more...

Project Management for the Phase 3 LCM Life Cycle Management of the Drug Development Process - Webinar by GlobalCompliancePanel This web seminar has been designed to provide you with a clear understanding of project management skills to apply to running phase 3 clinical trials.  more...

Complete Java Training ...ation Deployment * Development and Administration o Development Process o Assembling WARs o Administrative Tools o Administrative Tasks * Apache Tomcat web server training * Application development and deployment in Apache Tomcat * Web Application deployment in JBoss Integrated Development Environments * JDK 1. 6 * Eclipse 3. 4 or Any IDE (IntelliJ, NetBeans, IBM RDA  more...