Webinar Series Validation in Pharmaceutical Analysis: Calibration (Linearity)

Webinar Series Validation in Pharmaceutical Analysis: Calibration (Linearity)

Course No 18031

Important: Deadline is 12 noon on 28 July 2020

You will find all webinars of this series in this overview

Costs

THIS WEBINAR IS FULLY BOOKED (see information below)

The number of participants of this event is limited. Please enter your email address and click on Ask for available seats in order to get an information about available seats for this event:

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Joachim Ermer, Sanofi, Frankfurt, Germany

Background

According to EU GMP Guide Part 1, Chapter 6, Quality Control (6.15) and US 21 CFR 211.194, analytical procedures must be suitable for their intended purpose. The regulatory requirements to validation of analytical procedures utilised for release and stability studies of drug substances and drug products are described in the ICH guideline Q2(R1). However, its degree of detail is rather low and the discussion is mainly focused on chromatographic methods. The latter is one of the reasons for the just started revision of the guideline, as well as inclusion of lifecycle and risk management aspects, which gained increasing attention in the last years.

Target Group

The webinar is aimed at executives and employees from Quality Control, Quality Assurance, and regulatory who want to gain a better understanding of the GMP requirements as well as current trends and are interested in practical recommendations for an efficient design, execution, and evaluation of a succesful analytical validation.

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

Besides regulatory expectations, the Webinar series provides practical recommendations and orientation for demonstration of the suitability of analytical procedures. A rational and efficient validation approach is ultimatly based on the respective routine application, which should be reflected in the validation design. This includes the identification of the relevant performance parameters, the selection of appropriate tests and calculations and, in particular the establishment of acceptance criteria for the Evaluation.

The following topics will be covered in the part „Calibration“:
  • Regulatory requirements
  • Correlation or calibration?
  • Requirements to calibration models (linear single-point and multiple-point calibration, non-linear calibration, standard addition, internal calibration)
  • Suitable strategies to validate calibration models (linearity)
  • Statistical calculations (regression, suitable parameters)
  • Acceptance criteria for calibration function (residual and sensitivity plot) and ordinate intercept

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