Validation in Pharmaceutical Analysis - Live Online Training Lifecycle Concept and Precision

Validation in Pharmaceutical Analysis - Live Online Training

Course No 19433

All times mentioned are CEST.

Costs

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

(All prices excl. VAT)

* 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, this Live Online Training provides 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.

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 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

This Training 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 successful analytical 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.

Programme

Regulatory Requirements and the Lifecycle Concept for Analytical Procedures
  •  ICH Q2-Guideline – requirements and gaps
  •  ICH Q2-Revision and Q14 Development of Analytical Procedures (intended changes and content)
  •  USP <1220> Draft: The Analytical Procedure Lifecycle
  •  Requirements to the analytical performance (Analytical Target Profile)
  •  Verification of compendial procedures
Performance Attributes of Analytical Procedures
  •  Validation characteristics and error types
  •  Distribution of analytical data
  •  Evaluation of performance parameters (simple, statistical)
  •  Efficient validation
Precision
  •  Precision levels (system precision, repeatability, intermediate precision, reproducibility)
  •  Acceptance limits for assay
    •  Derivation from probability, measurement uncertainty, tolerance factors
  •  Concentration dependency of precision (Horwitz function)
    •  Acceptance limits for impurities
  •  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
Workshop: Multiple Choice Questions (from Publications)
  •  How to avoid mistakes in validation
 

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