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GxP Perspectives | Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters | carl1anderson.wordpress.com Reviews
https://carl1anderson.wordpress.com
Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters
carl1anderson.wordpress.com
FDA IP Labeling Requirements | GxP Perspectives
https://carl1anderson.wordpress.com/2012/04/29/4739
Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters. FDA IP Labeling Requirements. Does FDA Require an Expiration Date for IP? What are FDA’s requirements for labeling investigational drug and biological products (IP)? We are all aware of the required statement in 21 CFR 312.6,. However, is that the only requirement? What else, if anything, belongs? What labeling is against FDA requirements? Is this a GCP or GMP issue? What Are YOUR Viewpoints? G) New drug produ...
GxP Perspectives Calls it a Day | GxP Perspectives
https://carl1anderson.wordpress.com/2012/07/23/gxp-perspectives-calls-it-a-day
Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters. GxP Perspectives Calls it a Day. GxP Perspectives is Calling it a Day. On 13 February 2009 GxP Perspectives. Came into existence as the fledgling blog, Carl’s Blog on FDA Stuff. Since then the blog has published 202 additional posts, many by experienced GxP Professionals, and has accumulated 607 email subscribers and 577 members of the GxP Perspectives Linkedin Group. I realized that GxP Perspectives. 8216; da...
Quantifying Quality for GxP Compliance | GxP Perspectives
https://carl1anderson.wordpress.com/2012/04/08/quantifying-quality-for-gxp-compliance
Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters. Quantifying Quality for GxP Compliance. GxP professionals understand the need for quality and quality system and we discuss quality with one another on a daily basis. But how do we measure it? How do we quantify our results? In light of this, we would like to offer some ideas regarding how to measure quantify how good your quality is in tangible and practical terms. We contend that such metrics are useful in o...
FDA & EMA Regulatory Developments for eSubmissions | GxP Perspectives
https://carl1anderson.wordpress.com/2012/05/14/fda-ema-regulatory-developments-for-esubmissions
Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters. FDA and EMA Regulatory Developments for eSubmissions. Regulatory Developments for eSubmissions. Recent eSubmission-Related Regulatory Developments and the Impact on Sponsors. New Initiatives in Europe. New Developments in Europe. Sponsors are often challenged. Improvements to data quality and consistency during data entry. Access to the underlying data entered into the forms in an XML format. The FDA has final...
Response Letters to a Form FDA 483, Inspectional Observations | GxP Perspectives
https://carl1anderson.wordpress.com/2010/11/07/response-letters-to-a-form-fda-483-inspectional-observations
Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters. Response Letters to a Form FDA 483, Inspectional Observations. How Should You Respond to a Form FDA 483? What is an adequate response to a Form FDA 483. The Form FDA 483. Both FDA speakers stressed that the 483. Cochran gave an example of an adequate response to an FDA 483 for protocol violations. The response included a copy of a written procedure developed to prevent recurrence of the violation. The ...Shoul...
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MORIAH Consultant's Blog | Some regular thoughts about current issues in regulatory and clinical research | Page 2
https://moriahconblog.wordpress.com/page/2
MORIAH Consultant's Blog. Some regular thoughts about current issues in regulatory and clinical research. Upcoming Speeches & Presentations. August 19, 2011. Posted by Michael Hamrell in Regulatory Thoughts. In May 2011 the FDA issued an updated draft Guidance for Clinical Investigators, Industry, and FDA Staff: Financial Disclosure by Clinical Investigators”. This document is a revision of the original. Guidance for Industry: Financial Disclosure by Clinical Investigators. May 13, 2011. April 18, 2011.
FDA Publishes Final Guidance on Risk-Based Monitoring | MORIAH Consultant's Blog
https://moriahconblog.wordpress.com/2013/08/18/fda-publishes-final-guidance-on-risk-based-monitoring
MORIAH Consultant's Blog. Some regular thoughts about current issues in regulatory and clinical research. Upcoming Speeches & Presentations. FDA Publishes Final Guidance on Risk-Based Monitoring. August 18, 2013. Posted by Michael Hamrell in Regulatory Thoughts. The FDA recently published the final Guidance for Industry: Oversight of Clinical Investigations A Risk-Based Approach to Monitoring. In August 2013. This is the final version of the draft released in August 2011. Leave a Reply Cancel reply.
Updated PDUFA Law is Coming | MORIAH Consultant's Blog
https://moriahconblog.wordpress.com/2012/05/27/updated-pdufa-law-is-coming
MORIAH Consultant's Blog. Some regular thoughts about current issues in regulatory and clinical research. Upcoming Speeches & Presentations. Updated PDUFA Law is Coming. May 27, 2012. Posted by Michael Hamrell in Regulatory Thoughts. No comments yet — be the first. Leave a Reply Cancel reply. Enter your comment here. Fill in your details below or click an icon to log in:. Address never made public). You are commenting using your WordPress.com account. ( Log Out. Notify me of new comments via email.
Final new version of Declaration of Helsinki is Approved | MORIAH Consultant's Blog
https://moriahconblog.wordpress.com/2014/02/04/final-new-version-of-declaration-of-helsinki-is-approved
MORIAH Consultant's Blog. Some regular thoughts about current issues in regulatory and clinical research. Upcoming Speeches & Presentations. Final new version of Declaration of Helsinki is Approved. February 4, 2014. Posted by Michael Hamrell in Regulatory Thoughts. For more details on the final document and to obtain a copy visit: WMA page. No comments yet — be the first. Leave a Reply Cancel reply. Enter your comment here. Fill in your details below or click an icon to log in:.
FORUM 483: PROCEDIMENTOS DE GARANTIA DE QUALIDADE: Revisão Períódica do Produto.
http://forum483.blogspot.com/2011/02/procedimentos-de-garantia-de-qualidade.html
Neste forum são apresentados apontamentos originários dos FDA-483 com alguns comentários e aberto a outros com o propósito de discutir os não-cumprimentos, as recomendações de melhoria, as interpretações e tendências das regulamentações de forma a disseminar informações e sugerir ações pró-ativas de interesse do setor regulado. Quinta-feira, 17 de fevereiro de 2011. PROCEDIMENTOS DE GARANTIA DE QUALIDADE: Revisão Períódica do Produto. A Revisão Periódica do Produto (RPP) é um novo elemento de Garantia de...
FORUM 483: PROCEDIMENTOS DE EMBALAGEM: Limpeza e inspeção de liberação de linha
http://forum483.blogspot.com/2011/01/procedimentos-de-embalagem-limpeza-e.html
Neste forum são apresentados apontamentos originários dos FDA-483 com alguns comentários e aberto a outros com o propósito de discutir os não-cumprimentos, as recomendações de melhoria, as interpretações e tendências das regulamentações de forma a disseminar informações e sugerir ações pró-ativas de interesse do setor regulado. Segunda-feira, 17 de janeiro de 2011. PROCEDIMENTOS DE EMBALAGEM: Limpeza e inspeção de liberação de linha. No caso de reincidência como proceder? A investigação está completa?
FORUM 483: PROCEDIMENTOS DE EMBALAGEM: reconciliação de materiais.
http://forum483.blogspot.com/2011/02/procedimentos-de-embalagem.html
Neste forum são apresentados apontamentos originários dos FDA-483 com alguns comentários e aberto a outros com o propósito de discutir os não-cumprimentos, as recomendações de melhoria, as interpretações e tendências das regulamentações de forma a disseminar informações e sugerir ações pró-ativas de interesse do setor regulado. Sábado, 19 de fevereiro de 2011. PROCEDIMENTOS DE EMBALAGEM: reconciliação de materiais. C) There is no documentation concerning the issuance, use and return or destruction of un-...
On Biostatistics and Clinical Trials: August 2014
http://onbiostatistics.blogspot.com/2014_08_01_archive.html
On Biostatistics and Clinical Trials. CQ's web blog on the issues in biostatistics and clinical trials. Friday, August 29, 2014. Subgroup Analysis in Clinical Trials - Revisited. I had previously written an article about the sub-group analysis. EMA is again ahead of FDA in issuing its regulatory guidelines on this topic. Following an expert workshop on subgroup analysis. EMA issued its draft guideline titled “ Guideline on the investigation of subgroups in confirmatory clinical trials. Sometimes it is no...
FDA to revise regulations for acceptance of data from medical device trials conducted outside of US | MORIAH Consultant's Blog
https://moriahconblog.wordpress.com/2013/04/28/fda-to-revise-regulations-for-acceptance-of-data-from-medical-device-trials-conducted-outside-of-us
MORIAH Consultant's Blog. Some regular thoughts about current issues in regulatory and clinical research. Upcoming Speeches & Presentations. FDA to revise regulations for acceptance of data from medical device trials conducted outside of US. April 28, 2013. Posted by Michael Hamrell in Regulatory Thoughts. No comments yet — be the first. Leave a Reply Cancel reply. Enter your comment here. Fill in your details below or click an icon to log in:. Address never made public). Join 19 other followers.
FDA User Fees Reauthorized | MORIAH Consultant's Blog
https://moriahconblog.wordpress.com/2012/07/10/fda-user-fees-reauthorized
MORIAH Consultant's Blog. Some regular thoughts about current issues in regulatory and clinical research. Upcoming Speeches & Presentations. FDA User Fees Reauthorized. July 10, 2012. Posted by Michael Hamrell in Regulatory Thoughts. More details to follow as the final details are published. No comments yet — be the first. Leave a Reply Cancel reply. Enter your comment here. Fill in your details below or click an icon to log in:. Address never made public). Notify me of new comments via email.
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Blog de Carl1968 - Blog de Carl1968 - Skyrock.com
Mot de passe :. J'ai oublié mon mot de passe. Je suis grand 1m89 cheveux noir je suis marié et j'ai 5 formidables enfants. Mise à jour :. Abonne-toi à mon blog! Et voici mon fils au foot au RBDB il est gardien. N'oublie pas que les propos injurieux, racistes, etc. sont interdits par les conditions générales d'utilisation de Skyrock et que tu peux être identifié par ton adresse internet (67.219.144.114) si quelqu'un porte plainte. Ou poster avec :. Posté le jeudi 24 mars 2011 05:34. Ou poster avec :.
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CARL | Just another WordPress.com site
Just another WordPress.com site. November 28, 2010. Welcome to WordPress.com. This is your first post. Edit or delete it and start blogging! January 13, 2009. 上星期我們談到溫蒂 卡羅斯的 接電巴哈 專輯，在一九六八年的樂壇投下了一枚電子震撼彈，而這股震波也傳到了逐漸擺脫敗戰陰影，各領域發展直追歐美先進國家的日本。 一位年輕的音樂家著迷於卡羅斯豐富的音樂色彩，更驚嘆於封面上那具造型有如老式電話交換機的穆格 Moog 合成器之無窮潛力，他當下意識到這部機器不僅是一件可用於演奏的新樂器，更能創造出變幻無限的前衛聲響，不久即獨自以極高昂的代價進口了一套穆格類比合成器，開啟了日本電子音樂的新時代 他是日本的電子音樂先鋒 富田勳 Isao Tomita,1932。 大學尚未畢業的 田 開始接受ＮＨＫ 日本放送協會 等團體的委託，創作各類型的音樂 一九五五年畢業後成為一位多產的專業作曲家，作品包括紀錄片、大河劇以及動畫的配樂。 一九九七年映畫版的 獅王大帝 配...
carl1990's blog - Blogue de carl1990 - Skyrock.com
01/09/2012 at 5:54 PM. 04/09/2012 at 7:01 PM. J'peux t'rêver Mais tes plus belle que dans m. Subscribe to my blog! Mais tes plus belle que dans mes rêve. Je Vien donc te retrouver. Car je ne peux laisser l'temps te mener à moi. J'ai trop peur que le vent éloigne nos cœurs. Je fonce donc à contrecourant. Dans L'espoir de me rapprocher de toi. Et de m'installer dans ton cœur. Je ne veux de regret. Vien et saute dans mes bras. Tu y trouveras Beaucoup plus que la joie. Post to my blog. Here you are free.
GxP Perspectives | Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters
Commentary on FDA, clinical trials, research ethics, GCP, drug safety, and FDA Warning Letters. GxP Perspectives Calls it a Day. July 23, 2012. GxP Perspectives is Calling it a Day. On 13 February 2009 GxP Perspectives. Came into existence as the fledgling blog, Carl’s Blog on FDA Stuff. Since then the blog has published 202 additional posts, many by experienced GxP Professionals, and has accumulated 607 email subscribers and 577 members of the GxP Perspectives Linkedin Group. 8216; days were numbered wh...
Carl1N - DeviantArt
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carl1otta (carlotta) - DeviantArt
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carl1tos (carlos luis) - DeviantArt
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Carl2's Weblog | Just another WordPress.com weblog
Just another WordPress.com weblog. October 23, 2007. I like collecting plastic models of the new product called the bogie’s i have got doctor goo, octomus slime, bogeywan, slipsnot, frankenslime and jonny snotten. Heres a couple of pictures and of them. October 9, 2007. If you want cheats on club penguin use mine and sonicpops paintboy and legoless. I will soon try and upload the pictures its just my compter. New pin: hairbrush at the pet shop. New pin on friday. New experimental clothes on friday. If yo...
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