Webinar: Quality-by-Design Method Development – Replication Strategy

Webinar: Quality-by-Design Method Development – Replication Strategy

Course No 19411

Important: Registration Deadline is 12 noon on 29 September 2021.

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Speakers

Dr Joachim Ermer, Ermer Quality Consulting, Germany

Background

In the last two decades, the ICH process has emphasised the assurance of quality, safety, and efficacy of pharmaceutical products during the whole life cycle (ICH Q8-12, EU and FDA Guidelines on process validation). Applying the same principles to analytical procedures comes naturally and has been proposed by EFPIA/PhRMA working groups as well as USP Expert Panels since 2010, in several publications. The generally encouraging feedback resulted in the draft of a USP General Information Chapter <1220> “Analytical Procedure Life Cycle” [Pharm. Forum 46(5) 2020]. Such analytical lifecycle aspects will also be included in the revision of the ICH Guidline Q2 “Validation of analytical procedures” and the new Guideline Q14 “Analytical Procedure Development” – which face unfortunately further delay.

An important aspect of the analytical lifecycle management is a systematic (quality-by-design) method development to gain an enhanced understanding of the procedure’s performance. This is the basis to establish measures and controls of sensitive parameters in order to ensure the required performance during routine application. One aspect of this Analytical Control Strategy is a science-based establishment of the number of replicates of the routine method, i.e. the replication strategy.

Target Group

The webinar is aimed at executives and employees from analytical development, Quality Control, Quality Assurance, regulatory, and production who are interested in approaches of continual improvement of analytical procedures as the basis to efficiently control the quality of pharmaceutical products and manufacturing processes, or in current discussions regarding the Analytical Control Strategy.

Technical Requirements

For our Live Online Training Courses and 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

Repeated injections and preparations of sample and reference standard are often generically defined, or based on “tradition”. This Live Online Training provides the scientific and statistical background to optimise the precision of the reportable value of an analytical procedure to ensure its fitness for purpose. Impacting factors regarding the optimisation of variability by averaging will be discussed, providing practical orientation and recommendations for a QbD-replication strategy. Further, potential conflicts and solutions with regard to the current FDA-Guidance on OOS results are discussed.

The following topics will be covered:
  • Statistical background – precision of the mean (standard error)
  • Application to multiple precision levels & bioassays
  • What is the practical effect of increasing the number of determinations (dependence on relative variance contributions)
  • Optimisation under consideration of the uncertainty (confidence
  • interval of precision)
  • Prerequisites for an appropriate establishment of the replication
  • strategy (reliability of the variance contributions from precision studies)
  • Consideration of regulatory expectations- FDA (CDER) “averaging issue”

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