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Transfer of Analytical Procedures - Live Online Training

Wednesday, 19 June 2024 13.00 - 17.00 h

Seminar-Nr. 21282

Referent:innen

Dr. Joachim Ermer

Dr. Joachim Ermer

Ermer Quality Consulting

All times mentioned are CEST.

Zielsetzung

This Live Online Training provides regulatory requirements and recommendations with respect to the transfer of analytical procedures, e.g. from USP, WHO, and ISPE. Transfer can be regarded as the ultimate robustness check of the analytical procedure. Aspects neglected or missed during method development will often become evident.

Therefore, a meticulous planning and a prudent management of issues during the transfer are vital. A thorough Quality-by-Design method development or otherwise retrieved knowledge on the performance of the analytical procedure will facilitate an efficient planning of the transfer as well as increase the probability of success.

Hintergrund

The transfer of analytical procedures is a frequent activity during the lifecycle of a drug substance or drug product. Thus, it is regularly in the focus of audits and inspections. According to the EU GMP guide part 1, chapter 6, Quality Control, and US 21 CFR 211.194, QC laboratories which did not perform the original validation should verify the appropriateness of the testing method. The EU GMP guide (6.38 – 6.40) requires a protocol for this analytical transfer. The General Information Chapter of USP <1224> „Transfer of analytical procedures“ provides some detailed discussion of the process, including various transfer strategies such as comparative testing, co-validation, re-validation, and waiver.

Zielgruppe

This Live Online Training is aimed at executives and employees from Quality Control, Quality Assurance, and Production who want to gain a better understanding of the GMP requirements, as well as an efficient planning, execution, and evaluation of a successful method transfer.

Technical Requirements

We use WebEx for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings 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.

Programm

Transfer of Analytical Procedures - Live Online Training

Gesamtes Programm als PDF herunterladen

Regulatory Requirements and Expectations
  • Guidelines for transfer of analytical procedures
  • Analytical transfer as part of the lifecycle Management
  • Management of deviations, suspect and out-of-specification results
Management of the Transfer Process
  • Transfer Team
  • Transfer strategy
  • Protocol and report, documentation
  • Training
  • Root causes of issues during transfer
Rational and Efficient Design of Transfer Studies
  • Evaluation of results (simple and statistical comparison)
  • Risk-based design of effort
  • Acceptance criteria (accuracy and precision)
    • Capability-based (empirical, from validation, from monitoring)
    • Requirement-based (statistical derivation from specification limits, acceptable OOS rate)
  • Design of experimental studies (required number of series and determinations, dependent on acceptance limits and evaluation)
Lifecycle Approach
  •  Based on knowledge and data from continuous monitoring in the sending unit
  •  Initial transfer study by receiving unit only
    • “Lean” design, risk limitation for larger Errors/differences
  •  Post-transfer control by means of the monitoring program
    •  Chance to identify and evaluate small differences

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

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
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Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023

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