KMT KMTは、医薬開発のCMC(化学、製造および品質管理)分野で国内外の製?

23/05/2023

Five years ago, on May 21, I gave face-to-face explanations to the audience at the seminar venue according to my FB message. But due to the ongoing COVID-19 situation, my speech has been turned to be given online for about past three years.
Yesterday (May 22nd), we also explained on the live stream about the "Development of MF Registration Application documents to be reduced Inquiries". I hope to begin the seminars while watching the audience again, but my speech in July and September this year are still going to be live streamed.

12/12/2021

KMT staff gave a live online speech about analytical methods validation to pharmaceutical company staff for 5 hours at introductory workshop. I explained about relationship between Repeatability and Intermediate Precision / Reproducibility in detail at this time.
(Contents)
1. Specificity
2. Linearity
3. Range
4. Accuracy
5. Repeatability
6. Intermediate Precision
7. Reproducibility
8. Detection Limit
9. Quantitation Limit

December color near KMT office
12/12/2021

December color near KMT office

07/10/2021

KMT-member gave a live online speech about analytical methods validation to pharmaceutical company staff for 5 hours at introductory workshop.
(Contents)
1. What is analytical procedures validation?
2. About methodology for analytical procedures validation
3. About practical example of analytical procedure validation
4. What is verification of analytical procedures?
5. About the required acceptable level of validation characteristics

Cherry blossom near KMT
11/04/2021

Cherry blossom near KMT

On Tuesday 6th October I spoke on 'Validation of analytical testing methods' for 5 hours to the working staffs engaged i...
07/10/2020

On Tuesday 6th October I spoke on 'Validation of analytical testing methods' for 5 hours to the working staffs engaged in quality controls of pharmaceutical products via Internet.

Early summer flowers near KMT Office
23/06/2020

Early summer flowers near KMT Office

Spring flowers near KMT office
25/04/2020

Spring flowers near KMT office

The Notification on Change of Major part of buildings and facilities of the manufacturing establishment on Application f...
25/02/2020

The Notification on Change of Major part of buildings and facilities of the manufacturing establishment on Application for accreditation of foreign drug manufacturer has been submitted to PMDA (Pharmaceuticals and Medical Devices Agency).

Measurement of Newton-rings
21/01/2020

Measurement of Newton-rings

Autumnal sky and colors of the leaves in Japan
25/11/2019

Autumnal sky and colors of the leaves in Japan

KMT Pharm. Consulting Japan is the company who has been providing any support to the domestic and foreign pharmaceutical...
17/10/2019

KMT Pharm. Consulting Japan is the company who has been providing any support to the domestic and foreign pharmaceutical companies in the CMC (Chemistry, Manufacturing and Controls) field.

A staff at KMT spoke about Analytical method validation for 5 hours at the seminar held at Dawn Center near Tenmabashi subway station in Osaka on 11th October.

住所

東灘区住吉東町2-4-34/205
Kobe-shi, Hyogo
6580052

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