Read the full article: An Alternative to GMP Quality System Auditing in the Pharma Industry | FDAZILLA BLOG:
"Over the past four FDA fiscal years, the percent of warning letters that cite data integrity deficiencies has continued to increase"
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Showing posts with label data. Show all posts
Wednesday, January 18, 2017
Saturday, December 19, 2015
Reports Shine Light on Prevalence of Health Data Breaches - iHealthBeat
"About 90% of health care organizations have experienced a data breach within the last two years, according to the report.
The report predicted that cybercriminals will most likely focus their attacks on large insurers and health systems. However, it noted that "smaller incidents caused by employee negligence will also continue to compromise millions of records each year.""
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Wednesday, July 15, 2015
SurgeonRatings.org website makes data on surgeon performance public - CBS News
"A non-profit group is making millions of records on surgeon performance available to the public.
The consumer advocacy group Consumers' Checkbook launched the website SurgeonRatings.org, which provides open access to detailed government records on patient outcomes after surgery. It says the site was created after a ten-year campaign to convince the government to release Medicare records to the public."
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#FDA #GMP #training #cGMP
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Thursday, February 5, 2015
Massive breach at health care company Anthem Inc. - USA Today
"The hackers gained access to Anthem's computer system and got information including names, birthdays, medical IDs, Social Security numbers, street addresses, e-mail addresses and employment information, including income data, Swedish said.
The affected database had records for approximately 80 million people in it, "but we are still investigating to determine how many were impacted. At this point we believe it was tens of millions," said Cindy Wakefield, an Anthem spokeswoman.
That would make it "the largest health care breach to date," said Vitor De Souza, a spokesman for Mandiant, the computer security company Anthem has hired to evaluate its systems."
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Wednesday, November 5, 2014
GMP News: Statistical Analysis of FDA's Inspection Findings
Follow this link to view the graph: GMP News: Statistical Analysis of FDA's Inspection Findings:
"The observation summary counts more than 5.000 483 Forms - including in addition to drugs also further fields like foods which have been analysed separately.
Another interesting summary is the webpage with FAQs relating to the 483 Form.
The following graph shows an analysis of the 483 identified during fiscal year 2013." . . .
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"The observation summary counts more than 5.000 483 Forms - including in addition to drugs also further fields like foods which have been analysed separately.
Another interesting summary is the webpage with FAQs relating to the 483 Form.
The following graph shows an analysis of the 483 identified during fiscal year 2013." . . .
'via Blog this'
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Thursday, October 10, 2013
Does The Government Shutdown Impact FDA Inspections?
"Nonetheless, in no way does this mean to let down your guard.
When we get in the inspections data, we’ll have a clearer picture of what’s really going on. As you can see, the FDA is definitely already on pace for a slower year in terms of inspections and 483s."
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The Exemptee Institute
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Saturday, September 7, 2013
New - FDAzilla's FDA Inspections Database
Inspection and 483 data sliced and diced in a very interesting way. Check it out!
Start with the first link below to get oriented, then dive right in to the data via the second link below.
FDA Inspections Database is Now Available | FDAzilla Blog:
"We are proud to unveil the newest edition to the FDAzilla website – the FDA inspection database. You can search for company name, or you can drill down to the month, and then to the day, to see inspection details."
Follow this link to The FDAzilla FDA Inspection Dashboard and Database
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Start with the first link below to get oriented, then dive right in to the data via the second link below.
FDA Inspections Database is Now Available | FDAzilla Blog:
"We are proud to unveil the newest edition to the FDAzilla website – the FDA inspection database. You can search for company name, or you can drill down to the month, and then to the day, to see inspection details."
Follow this link to The FDAzilla FDA Inspection Dashboard and Database
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Wednesday, September 21, 2011
Will the FDA issue 10,000+ 483s in 2011?
FDA will issue 10,000+ 483s in 2011 – one every 52 minutes FDAzilla Blog: 'via Blog this'
The number is kind of shocking! According to the FDAzilla Blog:
"Based on new data obtained by FDAzilla, the FDA should surpass 10,000 483s in 2011 for the second time in its history, breaking its all-time record for the third consecutive year."According to e-How - The Definition of FDA 483:
FDA Form 483, is the form on which inspectors for the Food and Drug Administration detail unsatisfactory results of their inspection of manufacturing facilities for compliance with current good manufacturing practices (cGMP). The FDA inspects plants making human drugs (both prescription and over-the-counter drugs), animal and veterinary drugs, medical devices, food, radiation-emitting products, vaccines, blood and biological products and cosmetics for compliance with cGMP.
You might also be interested in:
An extensive library of 483 citation summaries from the FDA. Match the case with the corresponding 21 CFR 211 reference. Used as a classroom training tool or for self-study, this training aid challenges the student to identify and justify the 21 CFR 211 reference that supports the 483 citation.Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
Thursday, July 28, 2011
FDA Finds Faked Documentation At Cetero
This is a really good example of how improper documentation practices can get a company into real trouble.
Read this Reuter's release, FDA finds drug research firm faked samples, documents.
In a nutshell:
"The pattern of misconduct was serious enough to raise concerns about the integrity of the data Cetero generated during the five-year time frame," the FDA said, warning drugmakers they might have to repeat or confirm any studies Cetero did in support of their applications between April 2005 and June 2010.
Monday, June 27, 2011
How To Pass An FDA Audit - More Free Tips
More free tips on how to prepare and pass an FDA audit, from Arena Solutions, 5 Tips to Pass Your FDA or ISO Audit with Confidence.
In a nutshell:
- Document Your Standard Operating Procedures (SOPs)
- Train Your People
- Control, Track, and Manage Your Data Electronically
- Audit Yourself
- Have the Proof at Your Fingertips
You might also be interested in:
Surviving an FDA Inspection - a training course by SkillsPlus International Inc.
This class prepares plant personnel to participate in an FDA Inspection.Return Home: The Health, Drug, Prescription, and GMP Supersite Blog
Wednesday, March 9, 2011
FDA - Final MDDS Rule - Federal Register Full-Text
- You might also like FDA GMP QSR cGMP Training - online training courses by SkillsPlus International Inc. #FDA #cGMP #GMP #QSR #training
The original link broke.
You might also be interested in:
MDDS Rule - a webpage on FDA.gov
- - - the original post follows below - - -
The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements. This rule is effective April 18, 2011.
Read the full-text of the MDDS rule in the Federal Register [Volume 76, Number 31 (Tuesday, February 15, 2011)].
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You might also be interested in:
MDDS Rule - a webpage on FDA.gov
- - - the original post follows below - - -
The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls). MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices. An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements. This rule is effective April 18, 2011.
Read the full-text of the MDDS rule in the Federal Register [Volume 76, Number 31 (Tuesday, February 15, 2011)].
Return Home: http://drughealth.blogspot.com/
Monday, March 7, 2011
FDA Issues MDDS Final Rule
Updated March 11, 2021
Links broke in the original post.
People also search for MDDS Rule - FDA.gov
--- original post follows below ---
The FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.
Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification. Examples of MDDS products include: devices that collect and store data from a blood pressure cuff for future use or that transfer thermometer readings to be displayed at a nursing station for future use.
Here's a thought-provoking article, Final MDDS rule deems hospitals medical device manufacturers. In this article, it mentions, "The final MDDS rule will apply to “all manufacturers,” the FDA says. Critically, this includes hospitals, health care facilities or any other organization that does any of the following: . . ."
As of this writing, the Medical Device Data Systems rule will be published in the Federal Register. Read the rule here: Medical Devices; Medical Device Data Systems - FDA Final Rule (PDF).
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Monday, August 9, 2010
FDA Orange Book - Most Current Versions
Updated Aug 18, 2016:
FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post follows below - - -
The FDA ensures that the Orange Book data files are kept current. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files.
You can go to this FDA page to find the latest versions of the Orange Book, FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Included are the annual edition, supplements, and more, for this publication that identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.
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FDA's redesigned Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (webpage)
Updated Feb 3, 2016:
It's here! The latest Orange Book Annual Edition
You might also be interested in this webpage:
FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
- - - original post follows below - - -
The FDA ensures that the Orange Book data files are kept current. Every effort has been made to prevent errors and discrepancies in the Approved Drug Products data files.
You can go to this FDA page to find the latest versions of the Orange Book, FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Included are the annual edition, supplements, and more, for this publication that identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.
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Friday, July 24, 2009
Is FDA Watching Over Cell Phones as Medical Devices?
Updated March 24, 2021
People also search for the:
--- original post follows below ---
Lately at work I've been noticing some buzz about mHealth, mobile health. The intersection of mHealth, cell phones, and FDA regulation of medical devices seems to be happening, reports this Bob on Medical Device Software post, When Cell Phones Become Medical Devices. According to the post:
Mobile devices are quickly becoming the conduit of choice for collecting and disseminating clinical data. The FDA will soon be forced to step in and take regulatory control. It’s going to happen eventually.In a nutshell, it's time to start watching this, and paying attention to the possibility of having to follow FDA medical device regulations.
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Wednesday, December 10, 2008
FDA Data Guidance - When patients withdraw from clinical trials
How do you handle data when patients withdraw from clinical trials? For a well-written summary, read this post on the FDA Law Blog, "New Guidance Documents Available for When Subjects Withdraw from Clinical Trials." Thanks to Susan Matthees for writing this easily digestible article on the subject that includes links to the two guidance documents.
View more FDA Guidance Documents (free)
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Tuesday, November 18, 2008
FDA Scandal Brewing - Corrupted Scientific Reviews
Updated April 27, 2021
The original link broke.
You can still read about this topic in this article:
--- original post follows below ---
- Corrupted
- Interfered with
- Reprisals
- Threatened
- Accept data that isn't scientifically valid
- Avoid and evade any accountability
- Corruption, illegality, gross mismanagement and retaliation
- Felt pressured to alter their work for non-scientific reasons and provide misleading information
Return Home: http://drughealth.blogspot.com/ The Health,
Thursday, August 7, 2008
Big Brother Is Watching Your Prescription Data
Call it doing business, or be very, very scared. I ran across this Business News Blog post, "Prescription Data Used To Assess Consumers." There's a whole big industry growing that is collecting your prescription records in databases. We all need to monitor this very closely, because although this industry might contribute to better healthcare and savings, the flipside is there are possibly some real concerns about privacy that are outside the umbrella of regulators and lawmakers.
The discussion strikes a chord with me. As with so many things like this, it's possible for errors and incomplete information to get captured in databases. Although well-intentioned, a combination of many circumstances can lead to possible mis-interpretation, and just plain bad unjustifiable decisions and outcomes adversely affecting many consumers. Let's all hope for the best, and be sure to follow this closely.
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Sunday, July 27, 2008
21 CFR Part 11 - Masking Real Data For Testing
Creating test data for clinical computing or software is always a challenge. I found this interesting and helpful article on the 21 CFR Part 11 blog, "Protecting test data privacy when testing protocol amendments," which describes how to mask real data. This is important for a couple reasons. First, it's all so important to guard protected health information (PHI). Therefore, it's critical to avoid the easy path of testing with real live, production information about people. Second, creating meaningful, usable, test data from scratch can be an arduous task. Protect the privacy of the health information, and happy testing.
The Health, Drug, Prescription, and GMP Supersite: Resource List - FDA Part 11 - Electronic Records and Signatures
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