Bars

GMP Courses and Conferences

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Tuesday, 22 March 2022 14.00 - 18.00 h

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 validation characteristics, taking the - long-awaited - revision of the ICH Q2 guideline into consideration (provided a timely publication of the draft for consultation). 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 will also be 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 (valid May 1st, 2022).

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 (provided a timely publication), and who are interested in practical recommendations for an efficient design, execution, and evaluation of a successful analytical validation.

Programme


Lifecycle Concept, ICH Q2 Revision and Q14
  • Revision of ICH Q2-Guideline and Q14 Analytical Procedure Development – Mission accomplished?
  • The Analytical Procedure Lifecycle – USP General Information Chapter <1220> (valid May 1, 2022)
Analytical Target Profile
  • Requirements to the analytical Performance
  • Error types
  • Evaluation of performance parameters (simple, statistical)
  • Aspects of an efficient validation
Precision
  • Precision levels (system precision, repeatability, intermediate precision, reproducibility)
  • Acceptance limits for assay
    •  Derivation from probability, measurement uncertainty, tolerance factors
  • Design of precision studies and calculations
    •  Uncertainty of precisions: point estimators and confidence intervals
  • Optimisation of precision by averaging (replication strategy)
    •  Precision of the reportable value (small molecules, bioassay)
    •  Assay for small molecules, bioassay
Accuracy and Range
  • Comparison and recovery
  • Statistical significance and equivalence tests
  • Variability and expected difference between means
  • Acceptance criteria for Assay
  • Separate and combined evaluation of accuracy and precision
  • Range
Workshop: Multiple Choice Questions (from Publications)
  •  How to avoid mistakes in validation
 

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.