Webinar - Early Analytical Life Cycle Management for Drug Substances and Drug Products

Webinar - Early Analytical Life Cycle Management for Drug Substances and Drug Products

Course No 18179

Important: Deadline is 12 noon on 15 July 2020

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Speakers

Dr Gerd Jilge, Boehringer Ingelheim, Germany

Background

The assurance of ‘fitness for purpose’ of analytical procedures is a critical part of any process for ensuring drug quality. The current situation for analytical control laboratories is unsatisfactory as the ICH Q2(R1) “Guideline on Validation of Analytical Procedures: Text and Methodology” does not cover more recent application of analytical procedures, (e.g., Near Infrared (NIR) Spectroscopy or Raman Spectroscopy). Moreover there is no ICH guideline on Analytical Procedure Development. As a consequence applicants often report analytical validation results alone and rarely present performance evaluation with analytical development outcomes which makes regulatory communication ineffective. Therefore there is a need for a revised ICH Q2 Guideline and a new Analytical Procedure Development Guideline (ICH Q14). For simplification and clarity the ICH Expert Working Group is currently developing a combined document ICH Q2(R2)/Q14 which is intended to be available for public consultation in June 2020.

While this work is still under progress ECA’s Analytical QC Group has developed a new Guideline on Analytical Procedure Lifecycle Management. It is consistent with the ICH and USP principles and provides detailed assistance in their practical implementation.

Target Group

The webinar addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

This Webinar gives an explanation of the Analytical Lifecycle Management based on ideas created by a working group within the European Compliance Academy (ECA) but also includes trends which may be defined in the new ICH Guidelines.

Furthermore, this webinar gives an explanation,
  • the meaning of Analytical Quality by Design
  • how to apply the Analytical Target Profile (ATP) during development
  • and the impact on the ICH Guideline Q12 with respect to „Established conditions“ 
In addition, the „Analytical Control Strategy“ will be discussed demonstrating the so-called Criticality of an analytical procedure discussing first validation experiments to assess the procedures for its intented  purpose.

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