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80 results of "Life Sciences x" and "Clinical Research x"
Live Webinar

CAPA Under U.S. FDA / CGMPs and EU MDR / ISO

CAPA, Corrective and Preventive Action, is a major element of cGMP compliance, and one of the four key areas of a medical device QSIT inspection. CAPA is a key source of regulatory problems. The primary areas for CAPA focus.The roles of Failure Investigation a ...

Live Webinar

Compliance with the New ICH GCP Revision 2 Addendum – Know the How?

This webinar will cover these new requirements for running clinical trials, update you on further revisions of ICH GCP R2 and evaluate the changes and discuss how these should have been implemented for sponsors, CROs/vendors and study sites. This will enable y ...

  • Basic & Intermediate
  • 60 Mins
  • Laura Brown
  • May 01, 2019
Live Webinar

Process Validation for Drugs and Biologics

This course will provide participants with a thorough understanding of the requirements of process validation for both small molecule (pharmaceuticals) and Biologic products. Attendees will learn how to establish an effective process validation system and inte ...

Live Webinar

Risk management Planning in the EU

A medicine is authorized on the basis that its benefits outweigh its risks for the target population. However, not all potential or actual adverse reactions are identified by the time an initial marketing authorization is granted. The aim of risk management is ...

Live Webinar

Preparing Compliant eCTD Submissions: Are You Prepared for Upcoming FDA Mandate on e-Submissions?

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.

Live Webinar

Quality Control of Microbiological Media, Reagents and Test Kits

During this webinar, we will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits and reagents specifically applicable to microbiology laboratories to assess the acceptability of the performance of analytical mat ...

Live Webinar

Six Capabilities Necessary for an Effective and Efficient Quality Management System

The quality management system can be improved by understanding these six essential capabilities.The webinar will highlight warning signs and maturity levels for these six capabilities. Once companies understand their level of maturity, they can create concrete ...

Live Webinar

Human Factors Validation Testing following ISO62366 and FDA Guidance

This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quan ...

Live Webinar

21 CFR 111 GMP Dietary Supplement Laboratory

This training program will provide an overview of 21 CFR 111 regulatory requirements which governs how dietary supplements are manufactured and tested It will futher review the test procedures and documentation requirements to ensure regulatory compliance ...

Live Webinar

Quality Risk Management Overview

Attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM Explain the level of risk based on severity, occurrence, and detectability and how the QRM process is used to make decisions In addition they will b ...