Validation in Pharmaceutical Analysis - Live Online Training Specificity/Selectivity, Response (Calibration Model), Impurities and Quantitation Limit

Validation in Pharmaceutical Analysis - Live Online Training

Course No 20984

All times mentioned are CET.
 
All Information on Part 1 "ICH Q2 Revision, Lifecycle Concept, Precision, and Accuracy" can be found here.

Our Service

Costs

ECA-Member*: EUR 590,--
Regular Fee*: EUR 690,--
EU/GMP Inspectorates*: EUR 590,--
APIC Member Discount*: EUR 640,--

(All prices excl. VAT). Important notes on sales tax.

Registration
* also payable by credit card American Express Visa Mastercard

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, Ermer Quality Consulting, Germany

Objectives

Besides regulatory expectations, these Live Online Training Courses provide practical recommendations and orientation for demonstration of the on-going suitability of analytical procedures. A rational and efficient validation approach is ultimately 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.

Both training courses focus on the relevant performance characteristics, taking the - long-awaited - revision of the ICH Q2 guideline as well as the new Q14 guideline Analytical Procedure development into consideration. Lifecycle aspects will be included in the discussion.

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. A broader consideration of other analytical techniques as well as alignment with lifecycle aspects is intended with the revision of Q2. The latter also in the focus of the new ICH Guideline Q14 Analytical Procedure Development and is already content of the USP General Information Chapter <1220> The Analytical Procedure Lifecycle.

Target Group

These Live Online Training Courses are aimed at executives and employees from Quality Control, Quality Assurance, and regulatory who want to gain a better understanding of the GMP requirements for validation of analytical procedures, are interested to participate in a discussion of the revised ICH guideline Q2, and who are interested in practical recommendations for an efficient design, execution, and evaluation of a successful analytical validation.

Technical Requirements

We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-trainingtechnical- information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Programme

Specificity/Selectivity
  • Adjustments in ICH Q2(R2)
  • Comparison and (chromatographic) separation
  • Samples for investigation of specificity
  • Peak purity investigations
Response (Calibration Model)
  • Changes in the revised ICH Q2 guideline
  • Requirements to calibration models
    - linear single-point and multiple-point calibration,
    - weighted linear regression
    - non-linear calibration
  • Statistical calculations (regression, suitable parameters)
  • Acceptance criteria for calibration function
    - residual and sensitivity plot
    - ordinate intercept
Validation of Impurities
  • Concentration dependency of precision (Horwitz function)
  • Acceptance limits for accuracy and precision of impurities
  • Recovery
  • UV-response factors
Lower Range Limit Verification
  • ICH Q2(R2): Quantitation limit and reporting threshold
  • Capability and requirement-based quantitation limits
  • Determination of the quantitation limit (blank procedures, from response (calibration model), from precision)
  • Consideration of practical relevance (samples, concentration range for linearity approaches)
Workshop: Multiple Choice-Questions (from Publications)
  • How to avoid mistakes in validation

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