Target Group
Objectives
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.
Programme
- Guidelines for transfer of analytical procedures
- Analytical transfer as part of the lifecycle Management
- Management of deviations, suspect and out-of-specification results
- Transfer team
- Transfer strategy
- Protocol and report, documentation
- Training
- Root causes of issues during transfer
- 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)
- 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
Further Information
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 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.
Fees (per delegate plus VAT)
ECA Members € 690
APIC Members € 740
Non-ECA Members € 790
EU GMP Inspectorates € 690
The fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts:
Questions regarding content:
Ms Anne Günster (Operations Director), +49(0)62 21 84 44 50, guenster@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm (Organisation Manager), +49(0)62 21 84 44 49, helm@concept-heidelberg.de.
Date & Time
All times mentioned are CEST
Costs
| ECA-Member*: | € 690,- |
| Regular Fee*: | € 790,- |
| EU/GMP Inspectorates*: | € 690,- |
| APIC Member Discount*: | € 740,- |
(All prices excl. VAT). Important notes on sales tax.
not available
not available
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
Testimonials
