【超入門】ERES指針、21 CFR Part 11対応セミナー(5.ERES指針入門)

最近グローバルの規制当局は、医薬品企業・医療機器企業に対する電子記録・電子署名(ER/ES)の査察を活発に実施しています。
米国においては、1997年8月20日に21 CFR Part 11が施行されました。
また本邦においては、平成17年4月1日に「医薬品等の承認又は許可等に係る申請等における電磁的記録及び電子署名の利用について」(ER/ES指針)が発出されました。
2008年度から、EDCを利用した治験では、すでにER/ES指針査察が開始されています。
さらにPIC/Sにおいても、2013年1月1日に「PIC/S GMP Annex 11 Computerised Systems」が改定されました。
PIC/S GMP Annex 11は、21 CFR Part11への回答書と位置付けられ、最新のFDAの電子記録・電子署名に関する期待と指導を盛り込んだものとされています。
平成24年4月1日には、「コンピュータ化システム適正管理ガイドライン」が施行されました。この新ガイドラインの調査では、ER/ES指針を遵守しているかどうかも確認されています。
すでに指摘も出され始めました。
特にExcelを用いた、品質試験記録、品質試験成績書、出荷判定などは、要注意です。
なぜならば、Excelではセキュリティが十分ではなく、監査証跡も残せないからです。
再印刷し、バックデートでサインを行うといった不正も疑われます。
多くの製薬会社では、記録を電子で作成し、印刷したものに手書き署名(捺印)を行うといったハイブリッド運用を行っています。
ER/ES査察では、このようなハイブリッド運用において、紙が正か、電子が正かが問われます。
これまでほとんどの製薬会社では、紙を正としてきました。
しかしながら、今後はほとんどの場合、電子が正と判定されることになるでしょう。
Part11、ER/ES指針、ANNEX11は、非常に難解です。
本セミナーでは、電子記録・電子署名に関する規制要件をやさしく解説いたします。

【超入門】ERES指針、21 CFR Part 11対応セミナー
はじめに
1.電子化のリスク
2.電子生データとは
3.21 CFR Part 11入門
4.Part11の経緯と動向
5.ERES指針入門
6.PICS GMP Annex 11入門
7.Warning Letter


関連VOD配信セミナー
当社VOD配信セミナーは、視聴期間および回数制限はございません。
お好きな時間に、繰り返し何度でもご視聴いただけます。
【超入門】厚労省ER/ES指針、21 CFR Part 11対応セミナー
セミナービデオはこちら

関連商品

[blogcard url= https://xn--2lwu4a.jp/qms-csv/ title=”QMS(手順書)ひな形 CSV関連” ]

Related post

Comment

  1. best allergy medication for itching generic allergy pills how long do antihistamines take to work

  2. major brand allergy pills prescription strength allergy meds major brand allergy pills

  3. get sleep medication online uksleepingpillsonline.com

  4. basic care sleep aid order phenergan online

  5. deltasone over the counter buy generic prednisone online

  6. order prednisone 40mg without prescription order prednisone 20mg generic

  7. best otc antacid for heartburn glimepiride 1mg drug

  8. types of nausea medication buy baycip for sale

  9. dr prescribed acne medication monobenzone where to buy topical prescription adult acne medication

  10. adult acne causes in female order accutane 40mg pill best prescription topical for acne

  11. prescription only allergy medication fml-forte drug allergy pills on sale

  12. best otc for abdominal pain buy zyloprim no prescription

  13. medicines for heartburn by doctor medication to decrease stomach acid

  14. purchase absorica generic isotretinoin 40mg over the counter accutane medication

  15. order accutane 40mg pill order accutane for sale isotretinoin 20mg for sale

  16. buy sleeping pills uk online meloset for sale online

  17. order generic amoxil buy amoxil without a prescription order generic amoxil 1000mg

  18. sleep medication prescription online order provigil 200mg online cheap

  19. buy amoxil pills for sale order amoxil 1000mg pills amoxil 500mg usa

  20. cheap azithromycin 500mg azithromycin 250mg cost order zithromax pills

  21. buy gabapentin 100mg online cheap buy neurontin generic

  22. zithromax 500mg without prescription buy azithromycin 500mg buy zithromax 250mg pill

  23. buy gabapentin 100mg pills neurontin 800mg drug

  24. cost azithromycin 250mg cheap azithromycin buy azithromycin without a prescription

  25. buy furosemide pill order lasix 40mg online cheap

  26. azipro 500mg without prescription purchase azipro sale order azipro 250mg pill

  27. lasix 100mg pill purchase lasix generic

  28. order prednisolone 5mg online order generic omnacortil buy generic prednisolone over the counter

  29. omnacortil canada how to buy omnacortil omnacortil 5mg drug

  30. order deltasone 40mg sale order prednisone 5mg without prescription

  31. buy amoxil 500mg without prescription order generic amoxicillin 500mg order amoxicillin 1000mg generic

  32. order doxycycline 200mg for sale monodox ca

  33. amoxil pills brand amoxil 500mg amoxil 250mg drug

  34. buy monodox sale doxycycline order online

  35. order ventolin pills buy albuterol inhaler order albuterol inhalator online cheap

  36. purchase albuterol order ventolin inhalator online cheap buy albuterol pill

  37. augmentin 1000mg cost augmentin 1000mg oral

  38. amoxiclav order buy clavulanate sale

  39. where to buy synthroid without a prescription levothroid medication order levoxyl generic

  40. purchase levothyroxine pill buy generic synthroid 100mcg order generic synthroid 150mcg

  41. levitra uk purchase levitra generic

  42. buy levitra medication levitra generic

  43. buy clomiphene buy serophene generic serophene buy online

  44. buy clomid 100mg clomid 100mg ca serophene online buy

  45. cost semaglutide 14mg order generic rybelsus 14 mg rybelsus for sale online

  46. purchase tizanidine generic tizanidine online buy order tizanidine pill

  47. order rybelsus 14mg pill rybelsus over the counter buy semaglutide 14 mg pills

  48. order semaglutide 14mg online cheap rybelsus sale buy semaglutide 14 mg sale

  49. oral prednisone 20mg brand prednisone 5mg order generic deltasone 5mg

  50. generic deltasone 40mg buy deltasone 10mg pill prednisone 10mg pills

  51. where can i buy semaglutide buy semaglutide generic buy generic semaglutide 14 mg

  52. order accutane pill purchase isotretinoin pills accutane 40mg without prescription

  53. purchase accutane online cheap order isotretinoin pill accutane cost

  54. albuterol for sale albuterol brand buy albuterol 2mg

  55. order albuterol without prescription purchase albuterol sale albuterol 2mg over the counter

  56. generic amoxicillin 1000mg buy amoxil paypal order amoxil without prescription

  57. cheap amoxil generic buy amoxicillin for sale amoxicillin 1000mg canada

  58. augmentin 625mg pills buy generic clavulanate online buy augmentin 625mg online cheap

  59. order amoxiclav generic purchase amoxiclav amoxiclav pills

  60. buy zithromax 250mg generic azithromycin pill azithromycin 500mg over the counter

  61. azithromycin ca buy azithromycin pills azithromycin pill

  62. buy levothyroxine pills order levothyroxine generic order synthroid online cheap

  63. synthroid us cheap levothroid generic synthroid 150mcg uk

  64. omnacortil 5mg for sale cheap prednisolone pill order prednisolone 40mg pills

  65. omnacortil 10mg tablet omnacortil for sale omnacortil 10mg sale

  66. cheap clomiphene clomid 50mg oral buy clomid 50mg without prescription

  67. buy clomid 100mg online clomid pills buy clomiphene 100mg pills

  68. order neurontin 100mg for sale gabapentin 800mg over the counter order neurontin online

  69. buy neurontin 100mg online cheap buy gabapentin 100mg generic neurontin without prescription

  70. viagra mail order oral viagra 50mg order sildenafil generic

  71. sildenafil 50mg uk viagra 50mg drug order viagra 100mg sale

  72. buy lasix 100mg pill furosemide 100mg oral order lasix

  73. order lasix pill brand lasix 100mg generic furosemide

  74. buy rybelsus 14 mg for sale semaglutide pills order semaglutide online cheap

  75. buy semaglutide 14 mg without prescription rybelsus over the counter order semaglutide without prescription

  76. buy doxycycline pills for sale doxycycline 200mg for sale doxycycline price

  77. purchase levitra online order levitra 20mg online levitra 10mg generic

  78. order levitra 20mg pills buy vardenafil pills purchase levitra

  79. play casino real money slots real casino online

  80. best casino slots online casino online slots play casino slots

  81. plaquenil 200mg canada plaquenil for sale order plaquenil 200mg generic

  82. order lyrica generic lyrica where to buy purchase lyrica without prescription

  83. order plaquenil online hydroxychloroquine 200mg without prescription buy hydroxychloroquine 200mg without prescription

  84. order pregabalin 150mg buy lyrica 75mg online buy cheap pregabalin

  85. cialis for women cost cialis 40mg buy cialis 10mg without prescription

  86. order generic aristocort triamcinolone 4mg over the counter triamcinolone over the counter

  87. buy cialis cialis 40mg over the counter tadalafil liquid

  88. clarinex online buy buy clarinex pills for sale buy clarinex 5mg pill

  89. cenforce 50mg cost order cenforce without prescription buy cenforce pills

  90. purchase clarinex pill clarinex 5mg usa desloratadine generic

  91. cenforce 50mg tablet cost cenforce 100mg buy cenforce generic

  92. buy chloroquine 250mg online aralen oral chloroquine online buy

  93. claritin order online loratadine 10mg uk claritin online buy

  94. buy cheap chloroquine where can i buy aralen buy generic aralen online

  95. claritin tablet brand claritin claritin 10mg usa

  96. buy glycomet paypal glucophage 1000mg drug order generic metformin 1000mg

  97. purchase priligy order cytotec cytotec 200mcg pill

  98. oral glucophage 500mg order generic metformin 500mg buy glycomet pill

  99. dapoxetine 30mg us buy cytotec buy cytotec without a prescription

  100. buy generic glycomet 500mg glucophage 500mg pill purchase glycomet pills

  101. buy orlistat diltiazem cost order diltiazem pills

  102. xenical brand buy xenical 60mg without prescription buy diltiazem 180mg generic

  103. buy atorvastatin without a prescription lipitor 20mg brand lipitor 40mg us

  104. buy atorvastatin 10mg generic order atorvastatin 80mg for sale cheap lipitor 10mg

  105. norvasc 10mg oral amlodipine ca norvasc 10mg pills

  106. amlodipine pill order norvasc pills order amlodipine 10mg online cheap

  107. order acyclovir 800mg pill acyclovir 400mg drug order zyloprim 100mg online

  108. brand zovirax zyloprim 100mg brand buy allopurinol 300mg without prescription

  109. lisinopril 2.5mg generic order generic lisinopril 5mg buy generic lisinopril 5mg

  110. lisinopril 2.5mg brand order lisinopril 2.5mg generic buy zestril 5mg pills

  111. crestor price crestor order zetia order online

  112. buy rosuvastatin 10mg online where to buy ezetimibe without a prescription zetia 10mg usa

  113. order omeprazole generic buy prilosec 20mg pill cost omeprazole

  114. brand prilosec 20mg brand omeprazole 10mg brand omeprazole 10mg

  115. order motilium 10mg generic sumycin us tetracycline 250mg pills

  116. order domperidone 10mg pill oral tetracycline 250mg buy sumycin for sale

  117. lopressor where to buy order metoprolol 50mg pills order lopressor pills

  118. lopressor 100mg for sale order metoprolol pills lopressor 100mg over the counter

  119. purchase cyclobenzaprine without prescription lioresal order purchase baclofen generic

  120. buy flexeril pill buy flexeril generic order generic ozobax

  121. buy tenormin 100mg generic tenormin 50mg canada buy generic tenormin for sale

  122. oral atenolol 50mg buy atenolol pills for sale generic atenolol 100mg

  123. buy toradol online toradol price colchicine usa

  124. buy methylprednisolone pill purchase depo-medrol online cheap methylprednisolone buy

  125. methylprednisolone generic name medrol 4 mg otc methylprednisolone medication

  126. toradol brand oral toradol 10mg colcrys medication

  127. help with assignments australia academic writing online essay writers online

  128. cheap essay writer write thesis help writing paper

  129. buy inderal 10mg for sale generic plavix how to buy plavix

  130. oral inderal 10mg buy propranolol without prescription plavix 150mg pill

  131. methotrexate canada purchase methotrexate pills buy generic coumadin for sale

  132. buy methotrexate 10mg pills methotrexate oral medex where to buy

  133. order mobic 7.5mg generic purchase celebrex sale celecoxib drug

  134. buy mobic 7.5mg pill buy generic mobic purchase celebrex sale

  135. cost reglan 10mg hyzaar oral purchase losartan without prescription

  136. cost reglan order metoclopramide 20mg generic cozaar online buy

  137. buy flomax 0.4mg generic brand celebrex 200mg order celecoxib

  138. tamsulosin where to buy order flomax online brand celecoxib

  139. order esomeprazole 20mg online cheap order nexium 20mg pill topiramate 200mg brand

  140. order esomeprazole how to buy topamax cheap topamax

  141. brand ondansetron 4mg spironolactone 25mg price buy spironolactone pills for sale

  142. purchase ondansetron without prescription spironolactone 25mg drug aldactone over the counter

  143. order generic imitrex levaquin for sale levofloxacin 250mg cost

  144. imitrex 50mg pill buy levaquin paypal levaquin us

  145. brand zocor 20mg buy generic zocor over the counter valtrex without prescription

  146. buy zocor 20mg without prescription buy valacyclovir tablets order valtrex sale

  147. avodart 0.5mg generic avodart ca order zantac without prescription

  148. buy generic avodart over the counter avodart online ranitidine 150mg us

  149. proscar price finasteride 1mg pill diflucan 200mg usa

  150. buy ampicillin generic amoxicillin pills buy amoxil pills for sale

  151. brand ampicillin ampicillin online buy amoxicillin medication

  152. brand finasteride 1mg oral proscar diflucan cheap

  153. oral ciprofloxacin 500mg – cipro without prescription where can i buy augmentin

  154. ciprofloxacin 1000mg drug – order myambutol 1000mg without prescription augmentin 625mg for sale

  155. buy cipro 500mg online – order bactrim generic purchase amoxiclav pills

  156. order ciprofloxacin 500mg – buy myambutol pills for sale clavulanate generic

  157. ciplox online – ciplox 500 mg cheap order erythromycin 500mg online cheap

  158. order flagyl generic – order metronidazole 400mg without prescription order generic azithromycin

  159. flagyl order – cheap amoxil generic zithromax online

  160. order generic ciprofloxacin 500mg – ciprofloxacin 500mg sale order erythromycin 500mg sale

  161. ivermectin for covid 19 – cefixime cheap order generic tetracycline

  162. order valacyclovir without prescription – nemasole online order acyclovir buy online

  163. brand valacyclovir 1000mg – acyclovir online buy zovirax 800mg sale

  164. stromectol us – generic aczone order generic sumycin

  165. oral acillin buy amoxil medication amoxicillin pill

  166. brand metronidazole 400mg – terramycin 250mg sale cheap azithromycin 250mg

  167. order flagyl 400mg for sale – terramycin tablet azithromycin online buy

  168. buy ampicillin generic buy generic penicillin buy cheap generic amoxicillin

  169. buy generic furosemide – buy lasix pill diuretic captopril 25mg over the counter

  170. buy lasix no prescription – captopril price buy generic captopril 25mg

  171. metformin 500mg canada – order metformin 500mg pills lincomycin uk

  172. purchase zidovudine generic – buy zyloprim without prescription oral allopurinol 300mg

  173. glycomet 500mg ca – order generic glucophage 500mg buy lincomycin 500mg without prescription

  174. zidovudine 300mg over the counter – allopurinol medication

  175. oral clozaril 50mg – accupril 10 mg drug pepcid 40mg cheap

  176. clozapine 100mg canada – cheap aceon buy pepcid 20mg for sale

  177. buy quetiapine 50mg for sale – zoloft sale eskalith price

  178. buy seroquel without a prescription – bupron SR buy online buy eskalith tablets

  179. cost clomipramine 50mg – aripiprazole order order sinequan generic

  180. atarax 10mg cost – purchase nortriptyline online buy endep generic

  181. clomipramine generic – cheap paxil 10mg purchase sinequan for sale

  182. order hydroxyzine 10mg generic – buy buspar 5mg sale generic endep

  183. augmentin 625mg for sale – oral ciprofloxacin 500mg ciprofloxacin without prescription

  184. amoxicillin over the counter – cost duricef 250mg how to buy cipro

  185. cheap amoxicillin online – buy ceftin 500mg pills order cipro sale

  186. augmentin price – cipro 1000mg usa buy ciprofloxacin 1000mg without prescription

  187. buy azithromycin for sale – buy generic tetracycline buy generic ciplox

  188. cleocin 300mg pills – oxytetracycline over the counter chloramphenicol brand

  189. cleocin 150mg ca – buy vantin 100mg chloramphenicol us

  190. buy azithromycin for sale – buy sumycin sale buy ciprofloxacin 500mg pills

  191. ivermectin 3 mg online – eryc 500mg sale cefaclor 250mg tablet

  192. ventolin 4mg for sale – buy theo-24 Cr 400 mg generic buy theophylline 400mg generic

  193. stromectol australia – stromectol 6mg online cefaclor without prescription

  194. albuterol inhalator for sale – buy fexofenadine pills for sale order theophylline without prescription

  195. buy methylprednisolone usa – loratadine pills astelin 10 ml cost

  196. desloratadine cheap – beclomethasone cost order albuterol

  197. buy generic desloratadine over the counter – zaditor sale order ventolin 4mg generic

  198. methylprednisolone 4mg over the counter – buy azelastine sprayer astelin 10ml ca

  199. purchase metformin pills – purchase sitagliptin sale buy generic precose

  200. micronase brand – forxiga 10mg pill brand forxiga 10mg

  201. order micronase 5mg pills – glipizide 10mg cost dapagliflozin order online

  202. repaglinide buy online – buy empagliflozin 10mg sale empagliflozin pills

  203. prandin online order – order prandin online buy jardiance pills for sale

  204. glycomet 1000mg generic – buy generic acarbose online pill acarbose 50mg

  205. semaglutide pills – desmopressin buy online buy desmopressin medication

  206. buy terbinafine for sale – lamisil tablet order grifulvin v generic

  207. terbinafine cheap – order terbinafine 250mg online cheap grifulvin v over the counter

  208. buy semaglutide 14mg for sale – rybelsus medication buy desmopressin for sale

  209. order nizoral 200mg pill – purchase lotrisone without prescription sporanox 100mg drug

  210. ketoconazole 200mg over the counter – buy itraconazole generic order itraconazole 100mg generic

  211. buy generic famvir – acyclovir 800mg uk buy valaciclovir generic

  212. order lanoxin 250 mg sale – order dipyridamole 25mg generic lasix 40mg for sale

  213. famvir 250mg generic – purchase zovirax valcivir 1000mg oral

  214. purchase lanoxin for sale – buy generic lanoxin online generic furosemide 40mg

  215. buy metoprolol online cheap – olmesartan 10mg pill adalat 10mg cheap

  216. order hydrochlorothiazide 25 mg generic – buy lisinopril 5mg generic buy bisoprolol cheap

  217. hydrochlorothiazide 25mg drug – norvasc usa bisoprolol 10mg generic

  218. purchase metoprolol pills – lopressor 100mg uk where can i buy nifedipine

  219. cheap nitroglycerin – indapamide 1.5mg pills buy valsartan 80mg generic

  220. nitroglycerin generic – indapamide 2.5mg sale diovan usa

  221. simvastatin sell – lipitor stun lipitor possession

  222. rosuvastatin online money – pravastatin online shadowy caduet pills dot

  223. crestor live – zetia work caduet pills welcome

  224. zocor chill – gemfibrozil terrible lipitor divide

  225. viagra professional online fir – buy cialis professional sky levitra oral jelly online moody

  226. buy viagra professional shut – levitra oral jelly swear levitra oral jelly online myself

  227. dapoxetine heat – aurogra delight cialis with dapoxetine foot

  228. priligy ruin – fildena curiosity cialis with dapoxetine open

  229. cenforce guilty – zenegra online anyway brand viagra wade

  230. cenforce online snore – brand viagra pills finish

  231. brand cialis shelter – brand cialis hasty penisole pipe

  232. brand cialis boy – brand cialis cover penisole maid

  233. brand cialis shade – apcalis tempt penisole thud

  234. cialis soft tabs pills hey – viagra oral jelly hello viagra oral jelly online sink

  235. cialis soft tabs scholar – viagra oral jelly online court viagra oral jelly online final

  236. brand cialis speak – viagra soft tabs single penisole radio

  237. cialis soft tabs online crew – viagra super active online stay viagra oral jelly forehead

  238. cialis soft tabs frog – viagra oral jelly unfortunate viagra oral jelly pound

  239. priligy far – udenafil health cialis with dapoxetine accompany

  240. cenforce online object – online cialis brand viagra online orange

  241. cenforce model – brand viagra prove

  242. acne medication sweat – acne treatment reasonable acne medication whatever

  243. acne treatment mr – acne treatment remind acne medication refuse

  244. asthma treatment wear – inhalers for asthma tough asthma treatment immense

  245. prostatitis medications son – prostatitis pills hero prostatitis pills sleeve

  246. uti treatment pass – treatment for uti bridge uti treatment enormous

  247. uti antibiotics rent – uti medication mount uti medication jordan

  248. prostatitis treatment third – pills for treat prostatitis truth pills for treat prostatitis french

  249. claritin pills alone – loratadine medication realm loratadine charm

  250. valacyclovir online nail – valtrex online silk valtrex online memory

  251. valtrex frank – valtrex pills pipe valtrex pills wrong

  252. claritin pills release – loratadine medication batter claritin pills remind

  253. priligy rope – priligy hour priligy threat

  254. loratadine nearby – claritin pills reveal claritin pills hard

  255. loratadine button – loratadine medication duke claritin pills accompany

  256. dapoxetine vim – dapoxetine port dapoxetine mr

  257. ascorbic acid bad – ascorbic acid ghoul ascorbic acid indifferent

  258. promethazine just – promethazine refer promethazine local

TOP