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\u6bce\u65e5\u30e1\u30eb\u30dc\u30eb\u30f3\u3067\u3001\u533b\u7642\u901a\u8a33\u306f\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u533b\u7642\u7ffb\u8a33\u306f\u3001\u7ae0\u5b50\u3055\u3093\u304c\u304a\u3063\u3057\u3083\u308b\u3088\u3046\u306b\u3001\u547d\u306b\u95a2\u308f\u308b\u305f\u3081\u8cac\u4efb\u304c\u91cd\u304f\u3001\u8eab\u304c\u5f15\u304d\u7de0\u307e\u308b\u601d\u3044\u304c\u3057\u307e\u3059\u3002\u307e\u305f\u3001\u5c02\u9580\u7528\u8a9e\u304c\u591a\u304f\u3001\u30c7\u30a3\u30b9\u30b3\u30fc\u30b9\u3068\u3057\u3066\u306e\u533b\u7642\u7ffb\u8a33\u306f\u672c\u5f53\u306b\u30cf\u30fc\u30c9\u30eb\u304c\u9ad8\u3044\u3067\u3059\u306d\u3002\u3082\u3057\u3001\u6a5f\u4f1a\u304c\u3042\u308c\u3070\u79c1\u3082\u6311\u6226\u3057\u3066\u3001\u7ae0\u5b50\u3055\u3093\u304c\u304a\u3063\u3057\u3083\u308b\u3088\u3046\u3001\u300c\u76f4\u8a33\u3067\u306a\u304f\u3001\u81ea\u7136\u306a\u8a33\u6587\u300d\u306b\u306a\u308b\u3088\u3046\u3001\u307e\u305f\u300c\u60a3\u8005\u306b\u597d\u611f\u3092\u4e0e\u3048\u3001\u30c9\u30af\u30bf\u30fc\u306b\u30e1\u30c3\u30bb\u30fc\u30b8\u3092\u4f1d\u3048\u308b\u300d\u7b49\u3092\u5fc3\u3057\u3066\u9811\u5f35\u308a\u305f\u3044\u3068\u601d\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u300c\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\u306b\u8a73\u3057\u3044\u7ffb\u8a33\u8005\u3068\u3001\u533b\u7642\u7ffb\u8a33\u8005\u304c\u7d44\u3093\u3067\u300d\u306a\u3069\u3082\u7d20\u6674\u3089\u3057\u3044\u6848\u3060\u3068\u601d\u3044\u307e\u3057\u305f\u3002\u3044\u308d\u3044\u308d\u8cb4\u91cd\u306a\u7d4c\u9a13\u3084\u3001\u30ea\u30bd\u30fc\u30b9\u3092\u30b7\u30a7\u30a2\u3057\u3066\u9802\u304d\u3001\u5927\u5909\u52c9\u5f37\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u901a\u8a33\u8005\u7ffb\u8a33\u8005\u5354\u4f1a\u3067\u306f\u3001JLD\u306e\u69d8\u306a\u8a00\u8a9e\u7279\u6709\u306e\u6d3b\u52d5\u306f\u307e\u3060\u3001\u306a\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002\u7ffb\u8a33\u8005\u306f\u5bb6\u306b\u3053\u3082\u308a\u304c\u3061\u306b\u306a\u308a\u307e\u3059\u306e\u3067\u3001\u592a\u5e73\u6d0b\u3092\u8d8a\u3048\u3001\u771f\u590f\u306e\u30e1\u30eb\u30dc\u30eb\u30f3\u304b\u3089\u30ba\u30fc\u30e0\u3067\u6709\u76ca\u306a\u571f\u66dc\u65e5\u3092\u904e\u3054\u3055\u305b\u3066\u9802\u304d\u3001\u5927\u5909\u52b1\u307f\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u3053\u308c\u304b\u3089\u3082\u7686\u3055\u3093\u5b9c\u3057\u304f\u304a\u9858\u3044\u3057\u307e\u3059\u3002\u4eca\u5e74\u306f\u300111\u6708\u4e0b\u65ec\u306b\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u901a\u8a33\u7ffb\u8a33\u8005\u5354\u4f1a\u306e\u5168\u56fd\u4f1a\u8b70\u304c\u30e1\u30eb\u30dc\u30eb\u30f3\u3067\u958b\u304b\u308c\u307e\u3059\u306e\u3067\u3001\u3088\u308d\u3057\u304b\u3063\u305f\u3089\u3044\u3089\u3063\u3057\u3083\u3063\u3066\u304f\u3060\u3055\u3044\u3002\uff08Mikoto Araki \u8352\u6728\u7f8e\u7434\uff09<\/p>\n
<\/p>\n
I have had the pleasure of meeting Sasaki san once in person at the Chicago ATA so it was a pleasure to listen to her presentation \u6587\u7cfb\u51fa\u8eab\u8005\u306e\u305f\u3081\u306e\u533b\u7642\u7ffb\u8a33. A year ago, just before a pharma audit I had reached out to seek her advice and was the grateful recipient of valuable material related to CAPA which proved to be very useful in preparation for the project. It is heartening that there are still people like her who don\u2019t hesitate to help others as well as share their expertise and reference materials to someone who is relatively new to pharmaceutical audit interpreting. Even though I started off as a medical writer at a pharma company in Tokyo over 2 decades ago, I have not been that lucky in procuring medical translation projects other than some adverse event documents and discovery related files. After about five projects related to pharma audits in the past two years, including one involving PMDA I confess that such interpretation is as taxing to the brain as an exciting learning experience. My first ever pharma audit interpretation about two years ago was courtesy an amazing agent who convinced me to take it on. Although I was promised some study materials in advance, absolutely nothing was forthcoming save a capability presentation. My client contact, undoubtedly overwhelmed with last minute preparations, but also recognizing my urgency\/desperation suggested that I join them for a couple of hours mock site audit that they planning the day before. This proved to be a real eye opener. I was so relieved that even to the point of being annoying I managed to convince them allow me an exposure to the actual site. And oh, how very different that was compared to manufacturing sites that I had been used to!All my projects so far have been related to GMP audits of sterile manufacturing. I have benefited greatly from the plethora of information that is out there in the public domain starting with FDA warning letters, you tube videos showing sterile processing, CAPA, bioburden etc. This involved hours and hours of unpaid laborious work but was a rewarding learning experience. I cannot emphasize enough about creating thorough learning notes even it is via a word document and storing all the useful links to refer to. Taking a few paid GMP bootcamps also was a part of my learning strategy. I found that some Japanese clients are particular about past experience and these proofs of certificate of attendance may help.I should mention though that I had majored in chemistry from India several decades and worked for a couple of years in Japan as a medical writer after doing my Ph.D. in Japanese studies, I believe that one does not require a science background to interpret in pharma audits. Anyone who can diligently do focused study should be able to interpret at pharma audits with confidence.\u00a0 (Shivani Nandi)<\/p>\n","protected":false},"excerpt":{"rendered":"
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A year ago, just before a pharma audit I had reached out to seek her advice and was the grateful recipient of […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[1],"tags":[],"_links":{"self":[{"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/posts\/608"}],"collection":[{"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/comments?post=608"}],"version-history":[{"count":2,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/posts\/608\/revisions"}],"predecessor-version":[{"id":610,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/posts\/608\/revisions\/610"}],"wp:attachment":[{"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/media?parent=608"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/categories?post=608"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ata-divisions.org\/JLD\/wp-json\/wp\/v2\/tags?post=608"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}