s**********8 发帖数: 25265 | 1 Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
Introduction
Flexibility of the QS Regulation
Applicability of the QS Regulation
GMP Exemptions
Additional Quality System Information
Quality System Regulation and Preamble1
Introduction
Manufacturers must establish and follow quality systems to help ensure that
their products consistently meet applicable requirements and specifications.
The quality systems for FDA-regulated products (food, drugs, biologics, and
devices) ... 阅读全帖 |
|
s**********8 发帖数: 25265 | 2 http://www.qrasupport.com/FDA_MED_DEVICE.html
Overview: FDA Regulation of Medical Devices
The following information is provided as general guidance to the Food and
Drug Administration (FDA) regulation of medical devices. The Center for
Devices and Radiological Health (CDRH) is the division of FDA responsible
for medical device regulation. CDRH maintains a very informative web site.
The CDRH web site is located at: http://www.fda.gov/cdrh/devadvice/default.htm.
For support in working with the FDA... 阅读全帖 |
|
c***y 发帖数: 286 | 3 Bachus Urges Regulators Not to Rigidly Implement Volcker Rule
By DEBORAH SOLOMON
WASHINGTON-—Rep. Spencer Bachus, the Alabama Republican competing for the
reins of the House Financial Services Committee, warned regulators not to "
rigidly" implement a new rule aimed at curbing banks' risk-taking ability,
saying it will impose "substantial costs" on the economy.
Mr. Bachus's opposition to the Volcker rule, named after former Federal
Reserve Chairman Paul Volcker who also is an Obama administratio... 阅读全帖 |
|
l****z 发帖数: 29846 | 4 By Fred Lucas
November 30, 2011
White House Press Secretary Jay Carney speaks during the daily news briefing
at the White House, Tuesday, Nov. 29, 2011. (AP Photo/Carolyn Kaster)
(CNSNews.com) - President Barack Obama has not yet decided whether to go
forward with a proposed regulation under the health care law he signed last
year that would force Catholic individuals and instutions to act against the
teachings of the Catholic church.
In August, Health and Human Service Secretary Kathleen Se... 阅读全帖 |
|
S***x 发帖数: 2382 | 5 打个比方说,你有100块钱,是你的,但是别人会来抢。如果你自己保护不了,就被别
人抢了,这就是distortion,因为你会想抢回来。打来打去社会就乱了。没有
regulator的话,bad guys always win。
a fair regulator是用来enforce权利的。这100块钱是你的,谁来抢就违法,就打他,
打到他不敢来抢,这就是fair regulation。这样社会就有秩序,效率就高。
但是很少有fair regulator,因为他自己有利益关系。比如抢你100块钱的人和那个
regulator是好朋友,于是就睁一只眼闭一只眼,那你就变成了弱势群体,被虐的命。
这样社会效率就低。
西方的民主也产生不了fair regulator,谁上台都是代表大资本家来侵占小民的利益的。
所以从上层社会上,就是一场好人坏人的斗争。老毛是个fair regulator,这点很难得
。他缺的是经济学知识。 |
|
f*****b 发帖数: 175 | 6 上个礼拜passanger side的rear window不能自动关起来,估计是regulator或者window
motor坏了。于是自己就把motor和regulator拆下来,发现电机还好,regulator坏了
。考虑到这个车子再开一两年也就换了,于是从ebay买了一个regulator (价格低)。
昨天把regulator装上去之后,window打开关闭到时都没有问题。但是不如其他窗子那
么smooth,关窗的时候,当窗子快到顶端的时候,就觉得motor似乎不给力,现在觉得可
能的原因有如下:
1. motor可能也坏了。 在不装regulator情况下,电机转动自如啊。
2. Regulator可能和原装的比,设计上有些问题。 按理说,这么简单的一个件,不至
于出这个问题。
请有经验的高手指点一下。 |
|
p*********e 发帖数: 32207 | 7 ☆─────────────────────────────────────☆
utar (utar) 于 (Mon Aug 24 21:58:06 2009, 美东) 提到:
2002 E46 325I,passenger side rear window,
拆开发现有一个塑料滑轮从track上断裂掉下来了,整个钢丝绳都脱落了。
网上买的after market的window regulator,昨天花了一个半小时换上,装好以后试了
下,有点喀拉喀拉的声音,在窗户放到最下面的时候尤其严重,而且放到底的时候能看
到马达整体相对架子有微小转动(理论上马达应该是固定不动的,在窗户放到底之前也
确实不动)。
还有个问题就是控制开关窗户的时候可以推一下自动放到底,但是按一下自动升起来的
功能没了,必须一直按住开关才能升起来。
结果今天打开窗户以后又升不起来了,可以下,不能升。不至于坏这么快吧。
过两天有空再拆开看看,如果是regulator又坏了就郁闷了。
还是说马达也得换了?
☆─────────────────────────────────────☆
TTBJ (涛涛不觉... 阅读全帖 |
|
l****z 发帖数: 29846 | 8 Tuesday, July 19, 2011
Email a Friend Email to a Friend ShareThis
Voters think less government red tape and more competition are the best ways
to bring down health care costs.
Sixty-nine percent (69%) of Likely U.S. Voters believe greater free market
competition between insurance companies would do more to reduce health care
costs than more government regulation. A new Rasmussen Reports national
telephone survey finds that just 23% feel the more effective course would be
more government regulati... 阅读全帖 |
|
g********d 发帖数: 4174 | 9 http://www.nytimes.com/2011/01/13/opinion/13kristof.html?_r=1&r
Op-Ed Columnist
Why Not Regulate Guns as Seriously as Toys?
By NICHOLAS D. KRISTOF
Published: January 12, 2011
Jared Loughner was considered too mentally unstable to attend community
college. He was rejected by the Army. Yet buy a Glock handgun and a 33-round
magazine? No problem.
To protect the public, we regulate cars and toys, medicines and mutual funds
. So, simply as a public health matter, shouldn’t we take steps to reduce
the... 阅读全帖 |
|
l****z 发帖数: 29846 | 10 Study: Obama's 2013 Regulations Could Cost More Than $130 Billion
July 9, 2013 - 3:43 PM
By Joe Schoffstall
Current and proposed regulations put forward by the Obama Administration in
2013 could cost over $130 billion, according to newly released study.
The study, put together by the American Action Forum, takes a look at the
administration's spring agenda of current and proposed federal regulations-
known as the Unified Agenda. The Unified Agenda is released twice a year and
details the regulat... 阅读全帖 |
|
m********1 发帖数: 681 | 11 没有列constitution,因为那个东西基本上不可能改。
supreme court也只是对constitution有解释权而已。
constitution是基础,law(或者叫某某act)是在constituion上由congress和总统立
起来的,只要不违宪,law就不会被高院推翻。但law本身可以重新制定,但过程很麻烦
,要投票。根据law,政府部门再制定regulation. 只要regulation不违反law,包括制
定regulation的过程不违反law,regulation就不能被法官推翻。根据regulation,政
府在实施过程中还有policy和guidance,这个就很宽松了,写个memo,主管签个字就可
以实行。奥巴马的EO就是属于这一类。
如果政府在实施policy和guidance的过程中损害了stakeholder的利益,可能应该也会
被告。但是stakeholder的定义很广泛,估计这次针对vb的law suite就需要澄清谁是
stakeholder。 |
|
l****z 发帖数: 29846 | 12 The Environmental Protection Agency has been waging a regulatory war on
Texas—and losing in the federal courts. On Tuesday the U.S. Court of
Appeals for the D.C. Circuit struck down another misguided EPA rule.
Enacted in August 2011, the Cross-State Air Pollution Rule was supposed to
reduce air pollution emitted in one state and carried downwind to another.
Under the Clean Air Act, if pollution from the upwind state is causing the
downwind neighbor to fail federal air quality tests, then the EPA... 阅读全帖 |
|
f****t 发帖数: 15913 | 13 去年让plumber换了个新的pressure regulator,过了一年现在开sprinkler后,喷水象
尿尿,喷不原,把sprinkler关了测水压,是70PSI,把sprinkler打开测,跌到20 PSI
,家里开一个水笼头,水压会降10PSI,家里用水和sprinkler用水是在pressure
regulator之后分叉的,这应该是pressure regulator的过滤网堵了吧?
这个东西是装在地下的,清洗过滤网或换pressure regulator都要挖大坑,有什么一劳
永逸的解决方案吗? |
|
b******r 发帖数: 16603 | 14 According to a source within China's Ministry of Industry and Information
Technology (MIIT), relevant MIIT departments have drafted new regulations
for the online search industry, including restrictions that would affect
Chinese internet company Baidu's (Nasdaq: BIDU) paid search rankings. MIIT
is currently seeking feedback on the regulations, according the source, and
has no timetable set for implementation.
MIIT has reportedly been assessing search engine companies since as early as
2009 in or... 阅读全帖 |
|
i******1 发帖数: 9 | 15 不同的Gas Cylinder用的regulator不同。可以从网站(比如Airgas)或者客服那里了
解所需要的regulator的CGA型号(比如 CGA 590),然后选择相应的regulator就可以
了。regulator应该很多地方都可以买,比如Fisher Scientific。 |
|
g**1 发帖数: 10330 | 16 Canadian Official Calls for Removal of Key Software From 737 Max
“MCAS has to go,” a manager at Canada’s aviation regulator said in an
email to global peers, referring to software in the Boeing plane.
http://www.nytimes.com/2019/11/22/business/boeing-canada-737-max.html
Boeing’s 737 Max has been grounded since March, after two crashes killed
346 people.
Boeing’s 737 Max has been grounded since March, after two crashes killed
346 people.Credit...Lindsey Wasson/Reuters
Natalie KitroeffDavid Gelles... 阅读全帖 |
|
a**********s 发帖数: 50 | 17 http://www.washingtonpost.com/wp-dyn/content/article/2008/09/18/AR2008091803159_pf.html
'Always for Less Regulation'?
John McCain's record on Wall Street oversight gets some misleading spin from
Barack Obama.
Friday, September 19, 2008; A18
TO LISTEN to Sen. Barack Obama, Sen. John McCain is a Johnny-come-lately to
the cause of regulating financial markets. "He has consistently opposed the
sorts of common-sense regulations that might have lessened the current
crisis," Mr. Obama said in New Mexic |
|
P*********0 发帖数: 4321 | 18 老白茶袋子被击破了。
Greenspan is then asked point blank over his alleged belief in the ability
for the market to correct itself in lieu of government regulation.
Q. You mentioned in 2008 at a Congressional hearing that you had placed too
much faith into self-correction on the part of markets, so do you think the
new regulations will protect the public?
A. It’s doubtful. I was on the J.P. Morgan board where we were acutely
aware of maintaining our credit rating and how important that was. I thought
all ba... 阅读全帖 |
|
l****z 发帖数: 29846 | 19 by Jammie
You voted for this nonsense, America. Congratulations.
Some GOP lawmakers fear the worst.
Obama has spent the past year “punting” on a slew of job-killing
regulations that will be unleashed in a second term, said Sen. James Inhofe,
R-Okla. With the election over, it’s now “full speed ahead” for federal
rules limiting greenhouse gas emissions, requiring cleaner gasoline and
putting controls on drilling for oil and natural gas, said Inhofe, the
senior Republican on the Senate Env... 阅读全帖 |
|
l****z 发帖数: 29846 | 20 by: Alex Wayne
March 6, 2014
(Bloomberg) – Gary Cohen, the top U.S. health insurance regulator accused
by congressional Republicans of misleading them before the troubled start of
the Obamacare insurance website, will resign.
Cohen will step down as director of the Center for Consumer Information and
Insurance Oversight at the end of the month, when the first enrollment
period for the health-care law concludes, Marilyn Tavenner, the
administrator of the Centers for Medicare and Medicaid Services... 阅读全帖 |
|
b*****d 发帖数: 61690 | 21 The Obama administration issued more than $40 billion worth of "midnight"
regulations, according to a new study.
The business-minded American Action Forum (AAF) said Monday that federal
agencies issued 102 major rules in 2016 — including 38 major rules during
the two-month period between when President Trump was elected on Nov. 8 and
his inauguration last Friday.
The last-minute rush to regulate included $41.2 billion worth of final rules
issued since the election.
“There is little doubt politic... 阅读全帖 |
|
b*****h 发帖数: 78 | 22 06 camry driver side window regulator 变形,需更换。
local o'reilly and advancedauto 没有卖的(小地方就是不方便)。
toyota genetic 要 $150.
反正不是什么关键部件,不想多花钱。
上网查了查, http://www.partstrain.com/ 和 http://www.carpartswholesale.com/ 都有一种叫 replacement window regulator得卖,only $50!
请大家给说说:
1. 这种replacement window regulator能买吗?有人用过吗?
2. 这两个网站有人用过吗?
谢谢 |
|
d*b 发帖数: 21830 | 23 windows regulator一般不会出问题,出问题的大多是rail或者guide,因为rail或者
guide阻力增大导致regulator变形。所以无论如何,先检查rail或窗户的橡胶guide,
一般车行都是regulator和guide一起换的。 |
|
c*******e 发帖数: 655 | 24 你在动手拆regulator之前,最好先排除控制车窗上下的那个开关是否有问题(从其他
车门拆下来互换验证),这个车的这些鸟开关也经常坏,regulator如果是好的,你拆
下来也差不多废了(这个脑残regulator安装基本是一锤子买卖,一次安装不成功,就
很难搞了)。 |
|
e*********n 发帖数: 2 | 25 Changes to J-1 Exchange Visitor Regulations
This notice is to provide more detailed information about the changes to the
J-1 Exchange Visitor categories of research scholar and professor. On May
19, 2005, the Department of State revised the regulations that govern the J-
1 program but these changes could not be implemented until the Student and
Exchange Visitor Information System (SEVIS) was upgraded. That upgrade will
happen on November 3. 2006. Two revisions to these regulations concern
Was |
|
m******n 发帖数: 15691 | 26 这么说吧,NBA可以regulate 也可以不 regulate,绝绝大大多数美国公司都regulate员
工的speech,你可以随便speech,我也可以因为你的speech 合法炒鱿鱼 除非这个spee
ch是举报公司犯罪 |
|
l**********t 发帖数: 5754 | 27 For those who are interested in scientific research on religion:
Abstract:
Many of the links of religiousness with health, well-being, and social
behavior may be due to religion’s influences on self-control or self-
regulation. Using Carver and Scheier’s (1998) theory of self-regulation as
a framework for organizing the empirical research, the authors review
evidence relevant to 6
propositions:
(a) that religion can promote self-control;
(b) that religion influences how goals are selected, pursu... 阅读全帖 |
|
l*****g 发帖数: 2 | 28 1,package description:2008 Becker CPA Review Course: Regulation + course
CD
2,出版商:Becker
3,新旧程度: Like New
4,交换、出售、求购的价格:360.
5,邮寄方式 :Prefer Pick up(New York City),邮寄usps
6,其它补充说明:
Set includes:
Text Books and Data CDs
1 Regulation Textbook (w/Passmaster and Simulations Data CD)
Lecture CDS
1 set of Regulation video lectures (7 CDs total)
Course CD
Course CD expires on Sep.17 2009 with 1 installation.
7,广告的有效期: Until Sold
9,我的联系方式: c*******[email protected]或站内邮箱
10,物品来源:Becker
11,交易双方声明:materials in qu |
|
|
b********n 发帖数: 38600 | 30 Many people think Congress regulates Wall Street, but in fact it is Wall
Street that regulates Congress.
http://libertyblitzkrieg.com/2014/12/12/h-r-4681-passes-congres
H.R. 4681 Passes Congress – Justin Amash Calls It: “One of the Most
Egregious Sections of Law I’ve Encountered During My Time as a
Representative” |
|
发帖数: 1 | 31 http://www.bbc.com/news/world-asia-china-40239693
China pollution: Survey finds 70% of firms break regulations
11 June 2017
From the section China
GETTY IMAGES
Image caption
Air pollution is a major problem in Chinese cities
An inspection of companies based around Beijing found more than 70% were
violating air pollution regulations, Chinese state media says.
Firms pumped out more emissions than allowed, operated without licences or
had insufficient pollution control equipment, Xinhua news agency... 阅读全帖 |
|
B****u 发帖数: 89 | 32 我开的是2004年的Honda Accord LX Sedan。
前两天,驾驶位置的玻璃忽然摇不上去了,初步判断是Window Regulator坏了。
(以前右前侧的玻璃出现过同样问题,请人修的,发现还比较简单,这次决定自己修。)
也奇怪,Honda的这款车的Window Regulator这么容易坏么?不知其他人有无类似经验。
关键在于订购部件,选来选去,从Amazon上订了TYC 660110, 在订之前,
Amazon网页上还有个"Find Parts that fit your vehicle"的功能,把我车的全部信息
输入进去,
给出的结果是一个绿色对钩加上一句"This Product fits your 2004 Honda Accord".
于是,下单购买。
周六到货后,很费了一番周章,但死活寄来的东西TYC 660110,根本装不上去,
跟坏了的部件比较一下才发现,四个定位螺丝中有两个是不一样的!
又去Amazon上看了另外一个item, TYC 660064,查询结果居然也是‘fit'。
我晕,两个不同部件怎么可能同时都fit同一部车上的同一个部件呢?!?!
这回... 阅读全帖 |
|
f*****b 发帖数: 175 | 33 基本上就是四个螺丝固定regulator,按理说没有什么调整的空间。
不过我觉得你说的很对,应该是阻力变大导致点击速度变慢。
我再去调整一下regulator, 多谢。 |
|
f*****b 发帖数: 175 | 34 谢谢你的建议。
我的车是nissan maxima,应该是没有rail,guide。
就是在window的底部有一个夹子连到regulator.
估计还是regulator本身的问题。 |
|
c***x 发帖数: 1169 | 35 12年旧车驾驶员侧电动车窗问题,请教板上大牛!
症状:1年半前开始出现问题,车窗放下后无法完全关闭,另外有时还无法彻底放下,
具体就像一种没有劲儿的感觉,表现为上升和下降的速度越来越慢;症状逐渐加重,目
前只能上升和下降约2-3cm。
车店的解释:regulator或者motor或者both出现问题,修理需要$300。
我的计划:DIY,但是之前希望大牛指出到底是regulator还是motor的问题,多谢多谢!
旧车:99年corolla。 |
|
i*****t 发帖数: 24265 | 36 1 regulator阻力增加
2 motor热保护
3 motor长期导致磨损
如果还能动,可以打开diy,包括电机电刷清洗,regulator调节上油..... |
|
c*******e 发帖数: 655 | 37 你问错地方了,车版像军版一样已经沦为粪坑。
使用铆钉固定导轨的脑残设计很多,但这个棒子车的设计更加脑残。
你如果先搜一下这个车后窗的regulator长什么样子,你就会知道这个regulator是整个
一个大铁板,导轨与之不可分离,需要一起换,换这个铁板比较费劲,尤其脑残的是喇
叭也是铆钉在铁板上的,你要费劲取下来,再装到新的上面。
这个活儿,一般店里至少收200刀人工,零件在100以上。自己也能搞,费劲,而且有很
多trick。 |
|
c*******e 发帖数: 655 | 38 你问错地方了,车版像军版一样已经沦为粪坑。
使用铆钉固定导轨的脑残设计很多,但这个棒子车的设计更加脑残。
你如果先搜一下这个车后窗的regulator长什么样子,你就会知道这个regulator是整个
一个大铁板,导轨与之不可分离,需要一起换,换这个铁板比较费劲,尤其脑残的是喇
叭也是铆钉在铁板上的,你要费劲取下来,再装到新的上面。
这个活儿,一般店里至少收200刀人工,零件在100以上。自己也能搞,费劲,而且有很
多trick。 |
|
w********h 发帖数: 12367 | 39 感觉regulate和modulate两个意思差不多,可互换,“调控”,
但我个人在使用时觉得regulate的主语可以是物,而modulate更通常的主语是人。
mediate的意思都是不一样的,“在。。。的帮助下促成”。
like |
|
H****N 发帖数: 997 | 40 regulate, 通常指比较大幅度的控制,turn on and off a process; modulate, 在已
有的基础上做调整,幅度比较小;但regulate 和 modulate 没有明确的界限。
mediate则不同,是指协调两个或几个相关的processes。 |
|
g*****o 发帖数: 1564 | 41 let me give a try
regulate: mainly in the context of transcription regulation, eg., certain
transcription factor bind to the promoter region of a DNA sequence and
control the rate of the mRNA transcription
modulate: possibly refers to the signaling transduction that certain
signaling molecule (kinase) phosphorylate an amino acid in a downstream
protein and changes its activity
mediate: maybe A -> B -> C, then B mediate the effects from A to C?
vs. |
|
s**********n 发帖数: 868 | 42 There's no way this country can have a quick recovery.
The regulator has no magic power. They've done all what they should do, not
a bad job. They also have to deal with international relations before they
can provide further stimulus (with a higher deficit).
Confidence is important. Banks are able to raise more capitals from the
equity more now. The regulators should not remind people of toxic assets now
, instead they need to show confidence in the banks. Moreover, they ask them
to raise capit |
|
L*****n 发帖数: 21 | 43 【 以下文字转载自 EB23 讨论区 】
发信人: Lannian (Lan), 信区: EB23
标 题: Propose a proper regulation for extending the STEM OPT
发信站: BBS 未名空间站 (Fri Aug 14 18:37:26 2015, 美东)
相信大家都已经知道,最近通过的法院裁决认为DHS在2008年通过的STEM专业OPT 17个
月的extension因为没有经过公开听证而不合法,DHS需要在2016年2月之前通过正常程
序justify STEM OPT extension。
否则,所有STEM专业学生(包括现有opt的,现有opt extension的,尚未毕业的)都将
在2016年2月后无法拥有17个月的opt extension. 此外,这条法令将自明年2月起作废
现有的H1B Cap-Gap. 即H1B申请者即使获得签证,也无法在10月签证生效前自动延长
OPT。
根据目前紧张的H1B抽签情况,这直接意味着理工科学生毕业即面临回国工作。
请大家支持并帮助扩散下面的请愿,为挽救华人在美国职场及社会的岌岌... 阅读全帖 |
|
h********o 发帖数: 3320 | 44 看是什么活了,regulation经常更新,很多老的改造都不符合现在的regulation。 |
|
w***t 发帖数: 8175 | 45 water pressure regulator 上注明调节区域为25-75.测输出的水的水压为90左右。
这是不是说明water pressure regulator坏了,一定要换?
换这个容易不?
多谢!!! |
|
q*******0 发帖数: 4 | 46 Hi, I want to bring a multiple-function cooker from China, but I can't find
matched voltage regulator
(>800W), where can we buy voltage regulator? |
|
s*******l 发帖数: 60 | 47 Received Regulation T (RT) margin calls from Zecco.
Before QID splitted on Feb. 25, I bought some QID March and April calls. Now
all calls were wiped out.
Even ridiculously ZECCO informed I owe them money due to Regulation T (RT)
margin calls, and I must transfer cash into the account before March 4th.
Any comments and help are truly appreciated.
==================
Right.
But never use margin to buy anything. |
|
g*******h 发帖数: 1327 | 48 zuck 乐意接受适度的regulation。 fb以及整个使用data 的tech industry和
congress在接下来制定regulation,应该是有商有量了。
goooooooood news |
|
p*****p 发帖数: 61 | 49 【 以下文字转载自 Biology 讨论区 】
发信人: pharlap (梦), 信区: Biology
标 题: 求审稿机会(生物)--genomics, gene expression regulation, molecular biology
发信站: BBS 未名空间站 (Sat May 19 14:40:34 2012, 美东)
生物博士后,准备申请绿卡,需要积累审稿数量。
尝试给杂志编辑写了几封信没有回音,双管其下,也到这里来寻求帮助
领域关键词:
genomics,medical genomics,gene expression regulation, molecular biology,NGS
data analysis
希望得到推荐
有意帮忙者站内信件联系
非常感谢 |
|
l********n 发帖数: 10 | 50 I am a Piano Technology student from North Bennet Street School in Boston. I
have more than 1 year of experience in piano tuning, repairing and
regulations, and I'm able to solve piano problems such as sluggish keys or
broken/buzzing strings, etc.
Just with the thought that maybe it's the time to start my business in
Boston area, I'm offering piano tuning(including pitch raising/lowering) and
repairing service to people who need them. Now I'm charging tunings at a
student rate($75 per tuning, ex... 阅读全帖 |
|