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Article (3) Forced Degradation (1) HPLC (8) ICH (8) Lifecycle (2) Method development (1) Methods (1) MTS (1) MTS Helpdesk (4) OOS/OOT (2) Procedures (1) Stability (4) Troubleshooting (1) Validation (12) Video (4) Webinar (2)

  • NEW COURSE: What’s New in ICH Drafts for Q2(R2) and Q14?

    We are pleased to announce that we have a new course on the topic of the draft ICH guidance documents, Q2(R2) and Q14, that is aimed at both our previous learners who have completed our validation course, and also at anyone who is experienced in validation and wants to know more. The course is currently…

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    NEW COURSE: What’s New in ICH Drafts for Q2(R2) and Q14?
  • Course Calendar 2023

    The MTS course schedule for 2023 is now available For more information on any of our training courses, select from the course list. Contact us if you have any questions.

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    Course Calendar 2023
  • ICH Updates in Our Validation Courses

    Draft versions of the revision of ICH Q2, Validation of Analytical Procedures, and also the new guideline Q14, Analytical Procedure Development, were published on the 24th March 2022. We have modified our courses, ‘Validation, Verification & Transfer of Methods for Pharmaceutical Analysis,’ and, ‘Validation, Verification & Transfer of Methods for Biopharmaceutical Analysis‘, to ensure that…

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    ICH Updates in Our Validation Courses
  • JPAG Symposium: Stability VI

    The MTS consultant, Oona McPolin, will deliver a presentation entitled, ‘Challenges in Development and Validation of Stability Indicating Methodology‘ at the JPAG symposium, ‘Stability VI’ on the 30th June 2022, which will be held at the Royal Society of Chemistry in Burlington House, London. If you are interested in the analytical methodology used for supporting…

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    JPAG Symposium: Stability VI
  • Limit of Quantitation: Does it Matter?

    Defined as “the  lowest amount of analyte  in a  sample which  can be quantitatively determined with  suitable precision and  accuracy” in ICH Q2(R1), limit of quantitation (or ‘quantitation limit’ in the ICH terminology) is an important method performance characteristic which is typically demonstrated during analytical method validation. Although the concept of limit of quantitation (LOQ)…

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    Limit of Quantitation: Does it Matter?

Article (3) Forced Degradation (1) HPLC (8) ICH (8) Lifecycle (2) Method development (1) Methods (1) MTS (1) MTS Helpdesk (4) OOS/OOT (2) Procedures (1) Stability (4) Troubleshooting (1) Validation (12) Video (4) Webinar (2)