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翻訳 - 英語 30. Non-Conformance and Improvements on Previous GLP Inspections.
Items recommended for improvement:
(1) People who are engaged in testing should comply with SOPs in regard to deviation procedures based on article 6, paragraph (1), item (2) of the pesticide GLP standard.
Improvements:
In regard to minor deviations from the testing plan, it was stated in the SOP for the study director duties (SOP/Testing Supervisor/01-01:2007/02/15 Revised) that a deviation report is not required (instead, the study director records the deviation details and the evaluation of the impact on the test results in the raw data and final report based on the usual SOP).
翻訳 - 英語 Two cases shall be reported in regards to the effects of direct thrombin inhibitors such as warfarin and refludan during therapy on patients with combined immune heparin-induced thrombocytopenia and deep vein thrombosis.
翻訳 - 英語 The adverse effects on the digestive system for the medical treatment under development most commonly showed an incidence rate of 10% for nausea and vomiting, however there was recovery after discontinuation of generally mild concentrations of the investigational drug.
日本語 から 英語: 増配の承認 General field: ビジネス/金融 Detailed field: 経営
翻訳 - 英語 The board of directors have approved a substantial 16% dividend increase for the second half of the financial year based on an improvement in the financial situation of the company. This will be a 24% dividend increase for the year. The current fiscal year has seen an increase in sales of 23% and an increase in EPS of 15%.
日本語 から 英語: Phase III trials General field: 医療 Detailed field: 医療: 製薬
翻訳 - 英語 About the use of data for non-Japanese applicants.
The results of Taiwanese and Korean applicants who were targeted for the joint international phase III trial were combined with the results of Japanese applicants. The following justification is given as to why this use of data was deemed as appropriate.
The results of the international phase I trial and the domestic phase I trial as well as the pharmacokinetics of healthy non-Japanese and Japanese adults were similar. We think that the drug is unlikely to be affected by differences in ethnicity because it was confirmed that almost the entire drug is left unchanged after renal excretion. Also, the pharmacokinetic results obtained in the joint international phase III trial shows that it is possible to use results of Taiwanese and Korean people together because there was no pharmacokinetic difference of any clinical significance observed between these ethnicities.
日本語 から 英語: Software of the JXA-8230/8530F General field: 科学 Detailed field: 製造
翻訳 - 英語 This software is used for processing the acquired data by JXA-8230/8530F in off-line mode. You can perform the data processing equivalent to the one conducted by the EPMA control software of the instrument main unit by using the common user interface with the JXA-8230/8530F. When an energy dispersive X-ray spectrometer is configured in the EPMA main unit, you can also perform the processing of the data acquired by the (stand-alone) EDS analysis as well as the data acquired by the ED/WD combined analysis.
Moreover, it is also possible to reconstruct EDS maps from the data acquired using the EDS active map. It is also possible to display the electron image and X-ray image data other than the analysis data.
Member states have made the newly adopted RoHS directive (2011/65/EU) mandatory for inclusion in domestic law from January 2, 2013. This directive will continue to apply until January 2, 2013 when this directive becomes part of domestic law (article 25, section 1). From the adoption of the new RoHS (2011/65/EU), this directive will be referred to as “RoHS I (RoHS one)”.
The applicable electrical equipment are devices that are used at a rated voltage not exceeding an alternating current of 1000 V and a direct current of 1500 V. Applicable devices are determined in accordance with the WEEE directive and include 1. Large household appliances, 2. Small household appliances, 3. IT and telecommunications equipment, 4. Audio-visual equipment, 5. Lighting equipment, 6. Electrical and electronic tools, 7. Toys, leisure, and sports equipment, 10. Automatic dispensers, and fluorescent lamps. Essentially, all electrical and electronic equipment may be considered as applicable; however, spare parts that are used for repair or recycling of equipment sold prior to July 1, 2006 are exempt.
Member states are prohibited from using new equipment sold after July, 2006 that contain lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyl (PBB), and polybrominated diphenylether (PBDE). The use of these six substances is now prohibited due to design changes of equipment and alternatives use of substances. However, an exemption can be granted under a new condition if 1. Using alternative substances is technically or scientifically unfeasible, or 2. The negative impacts to the environment, health, and consumer from using the alternative substance outweigh its benefits. Member states must establish domestic law that enacts this directive before August 08, 2004 including penalties for non-compliance.
Extensive experience in the translation of operation manuals and procedures for electron microscopes, mass spectrometers, industrial equipment, medical devices, and other scientific instruments for leading Japanese manufacturers.
Numerous translations and proofreading of material safety data sheets (MSDS) for chemical substances.
Various laboratory reports that analyzed samples for microbiological, chemical, and physical hazards for laboratories throughout Japan and overseas.
Technical Information notification regarding upgrades, modifications or non-conformities in regard to scientific equipment.
Translation of audit reports for several major US pharmaceutical companies. Content includes ISO requirements, GMP requirements, legal requirements, and supplier requirements.
Translation of medical journals for the FDA and other medical institutions such as "The Journal of Japanese Respiratory Society", "The Allergy Journal", "The Journal of Therapy", and the "Japanese Journal of Dermatology" and reports for research institutions such as "The Tokyo Metropolitan Institute of Public Health".
Member of RAM Translations who specialize in medical and science related translations.
Quality Related Translations
Experience in the translation and proofreading of quality manuals, product specifications, and procedures for numerous manufacturers in Japan. I have extensive knowledge and practical experience regarding ISO standards and GMP concepts. Concepts include cleaning validation, process validation, analysis method validation, equipment qualification, document control, laboratory control, in-process control, distribution and warehousing, contamination control, risk management, statistical process control, six sigma concepts, cold chain storage, and other.
Translation of cause analysis reports and business letters in regards to customer complaints raised by overseas clients for a leading food manufacturer in Japan.
Translation of MSDS, HACCP and GMP related documents for pharmaceutical and food manufacturers.
Financial Related Translations
Ongoing 2 year translation project for a major Japanese tech company in regard to an upgrade of their computerized accounting systems including functions for Oracle and other internal systems.
On-site audit translations of accounting reports such as control testing and substantive testing, descriptions of internal controls, and descriptions of computer system functions of programs such as Oracle and Felix.
Accounting practices for Independent Administrative Institutions (IAI).
Various PowerPoint presentations used for business seminars and education.
Practical Experience Applicable to Translation
Lead Auditor for Quality and Food Safety Management Systems (ISO 9001 and 22000).
Lead Auditor for cGMP audits and technical reviewer of audit reports.
Performed over 100 quality and supplier audits for a variety of chemical, food, and pharmaceutical manufacturers in Japan for over 7 years.
Currently working in-house as a contracted translator with engineers at a leading Japanese manufacturer of scientific equipment. Duties include translation of manuals and technical information.
Qualifications
American Society for Quality (ASQ) ASQ-Certified Biomedical Auditor (CBA) (Cert. No. 1343)
International Register of Certificated Auditors (IRCA) Lead Auditor for Quality Management Systems (QMS) (Cert. No. 1188665).
Food Safety Lead Auditor Certificate (Certification no. 3040).
Bachelor of Commerce from Otago University, New Zealand.
In-house training on technical writing in accordance with The Microsoft Style Guide for Technical Publications and The Chicago Manual of Style.
Capable of using translation software and CAT tools such as SDL Trados Studio 2014 and Felix.
専門知識分野