Live Online Training: Transfer of Analytical Procedures

Live Online Training: Transfer of Analytical Procedures

Course No 18821

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)

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

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.

Background

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.

Target Group

This 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

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 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

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