Navigation Links
FDAnews Announces Clinical Quality Assurance Workshop
Date:2/2/2013

FALLS CHURCH, Va., Feb. 2, 2013 /PRNewswire-iReach/ -- Clinical Quality Assurance
Roles and Responsibilities for Auditors and Managers
**Presented by MSceppa Consulting and FDAnews**
Feb. 27-28, 2013 – Raleigh, NC

www.fdanews.com/ClinicalQuality

(Photo:  http://photos.prnewswire.com/prnh/20130202/CG52775)

Now you can learn how to FDA-proof your CQA audits … eliminate costly mistakes … and avoid FDA warning letters that say:

"You failed to obtain and document that valid informed consent was obtained for each of the subjects enrolled in the study as required by stated regulations."

Clinical trial sponsors rely on clinical quality assurance (CQA) auditors to find vulnerabilities before noncompliance can shut down their studies.

But with millions of dollars and decades of research at stake, study staffers aren't always eager to cooperate.

That's why even the most experienced CQA auditors must apply the necessary tools and skills to the CQA function, including how to:

  • Understand the basic principles of GCPs and international regulations
  • Determine if GCPs are being followed and what needs to be documented
  • Balance the relationships — QA, clinical and the CRO — in the ever-changing economy where clinical study outsourcing is common
  • Define responsibilities with outsourced clinical trials and the role communication plays in maintaining compliance
  • Select sites to be audited — strategies for deciding who to audit
  • Audit a CRO or central laboratory — who and how do you audit these specialized providers
  • Manage the audits (logistics, time, etc.) — understanding the management of the audit
    '/>"/>

SOURCE FDAnews
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. FDAnews announces Biopharmaceutical Good Distribution Practices Summit
2. FDAnews announces Fifth Annual Risk Management & Drug Safety Summit
3. FDAnews announces Third Annual Pharmaceutical Labeling Summit
4. FDAnews Announces Medical Device Mobile Apps Virtual Conference
5. FDAnews announces Fourth Annual Supplier Quality Congress
6. Neurocrine Biosciences Announces Conference Call And Webcast To Present Fourth Quarter And Year-End 2012 Financial Results
7. iBio Announces At-the-Market Equity Offering
8. Pharmaceuticals Announces $1.5 Million Second Closing in Private Placement
9. Cardica Announces Fiscal 2013 Second Quarter Financial Results
10. Oclaro Announces Second Quarter Fiscal Year 2013 Financial Results
11. KaloBios Pharmaceuticals Announces Pricing of Initial Public Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2014)... , Sept. 19, 2014 Kiromic, LLC, a ... of Kent Hance , the former chancellor of Texas ... retired as chancellor in July 2014, after raising $1.2 billion ... that Kent Hance , the most successful chancellor in ... team not only as an investor, but also as our ...
(Date:9/19/2014)... 2014 Research and Markets has announced ... Autoimmune, Cancer, Diarrhea, Mental Disorder) Market - Forecast to 2023" ... of this report, the human microbiome market is segmented by ... market is expected to be valued as $294 million in ... 22.3% within the forecast period of 2019-2023. The market is ...
(Date:9/19/2014)... 2014 Five MinuteClinic walk-in medical clinics are opening inside ... area. Three clinics opened in Memphis and ... will be added in Springfield on September ... is expected to open October 22.  MinuteClinic is the largest and ... United States . The Memphis ...
Breaking Medicine Technology:Former Texas Tech Chancellor Named New Vice Chairman of the Board of Kiromic, LLC 2Global Human Microbiome (Diabetes, Obesity, Autoimmune, Cancer, Diarrhea, Mental Disorder) Market - Forecast to 2023 2Global Human Microbiome (Diabetes, Obesity, Autoimmune, Cancer, Diarrhea, Mental Disorder) Market - Forecast to 2023 3MinuteClinic Walk-in Medical Clinics Opening in Memphis 2MinuteClinic Walk-in Medical Clinics Opening in Memphis 3
... N.Y., June 27, 2011 Consumers have a growing appetite ... market opportunity for device manufacturers that has barely been tapped, ... The company also unveiled a list of possible wellness device ... how people live, exercise and interact with their healthcare provider ...
... Texas, June 27, 2011 Luminex Corporation (NASDAQ: ... acquisition of privately-held EraGen Biosciences, Inc., an innovator in ... applications, for $34 million in cash. (Logo: ... acquisition will add between $5 million and $7 million ...
Cached Medicine Technology:IBM Study Identifies New Generation of Connected Health Devices 2IBM Study Identifies New Generation of Connected Health Devices 3IBM Study Identifies New Generation of Connected Health Devices 4IBM Study Identifies New Generation of Connected Health Devices 5Luminex Corporation Completes Acquisition of EraGen Biosciences, Inc. 2Luminex Corporation Completes Acquisition of EraGen Biosciences, Inc. 3
(Date:9/20/2014)... Mexico (PRWEB) September 20, 2014 Villa ... the resort did not experience any damage in relation ... amenities and activities available. , Hurricane Odile struck Cabo ... intense wind, rain and powerful surf conditions. Located on ... Palmar Islands of Loreto experienced some heavy rain, but ...
(Date:9/20/2014)... 20, 2014 Ticket Down is ... tickets. This popular ticket exchange is offering their customer ... is nearing that next step in the entertainment business. The ... in the music and entertainment business, but is closing in ... straight No. 1 album, will hit the road next year ...
(Date:9/20/2014)... September 20, 2014 The print ... today’s edition of the Calgary Herald, with a ... readership of 270,000. The digital component is distributed ... across a network of top news sites and ... the campaign, visit http://www.worklifebalanceinfo.ca . , The ...
(Date:9/20/2014)... (HealthDay News) -- As flu season approaches, the best ... get a flu shot and a checkup, according to ... doctor can vaccinate people against the flu, and also ... Retail stores may provide flu shots for their customers, ... Jorge Parada, medical director of infection prevention and control ...
(Date:9/20/2014)... New PharmaPoint Drug Evaluation report, “Symbicort ... The asthma market saw very slow growth over ... with relatively efficacious standard therapies, such as short-acting ... long-acting beta-agonists (ICS/LABAs), and leukotriene modifiers, and has ... launch of seven novel targeted biologic agents and ...
Breaking Medicine News(10 mins):Health News:Villa del Palmar at the Islands of Loreto Fully Functioning After Hurricane 2Health News:Villa del Palmar at the Islands of Loreto Fully Functioning After Hurricane 3Health News:Ariana Grande Tickets in Chicago/Rosemont, Kansas City, Milwaukee, Saint Paul, Dallas, Houston, San Antonio, Oklahoma City Go On Sale Today 2Health News:Ariana Grande Tickets in Chicago/Rosemont, Kansas City, Milwaukee, Saint Paul, Dallas, Houston, San Antonio, Oklahoma City Go On Sale Today 3Health News:Getting ‘Wellthy’: Mediaplanet’s “Work-Life Wellness” campaign puts stock in the personal and economic gains of healthy, vital workplace environments for Canadians 2Health News:Get a Flu Shot During Checkup, Doctor Says 2Health News:Symbicort Asthma Market Forecasts to 2023 - Overview, Efficacy, Safety & SWOT Analysis in New Report Available at LifeScienceIndustryResearch.com 2Health News:Symbicort Asthma Market Forecasts to 2023 - Overview, Efficacy, Safety & SWOT Analysis in New Report Available at LifeScienceIndustryResearch.com 3Health News:Symbicort Asthma Market Forecasts to 2023 - Overview, Efficacy, Safety & SWOT Analysis in New Report Available at LifeScienceIndustryResearch.com 4
... is too expensive to eat a well-balanced diet may be surprised ... have changed eating healthily may actually be cheaper than their current ... New York, suggested that a healthy diet does not have to ... time, the cost of a healthy diet may be less than ...
... of removing cancerous kidneys through a small incision with ... and instuments. This is the hand-assisted Laproscopic technique, which ... standard laproscopic procedure. ,The research, being presented at the ... from the University of Michigan(U-M) Health System,// U.S., may ...
... which can be hard on the body. Stress affects the ... take to reduce impact of stress, and it's probably good ... sales rep, found that appointments and deadlines can be stressful. ... seem small, but they do tend to affect your blood ...
... Epidemiology, Biomarkers and Prevention, eating a daily multivitamin with ... the genetic risk of developing colon cancer. ,According ... colon cancer -- a parent or sibling are at ... Fuchs, lead investigator and assistant professor of medicine at ...
... by a biomedical engineer at the University of Pittsburgh ... of your eyes. The prototype device merges the visual ... ultrasound scan of what lies beneath. It creates the ... actual 3D location with the patient, showing blood vessels, ...
... nanobots it not with us yet, a tiny, inexpensive motor ... in the near future, according to Penn State engineer.,The smallest ... State’s Materials Research Institute is about the size of a ... 4 mm long.// ,Tiny, but powerfull, the smallest motor’s ...
Cached Medicine News:Health News:Eating healthy is cost effective 2Health News:Lessening operation and recovery time 2Health News:Folic Acid blows Gene-based Colon Cancer 2Health News:New form of ultrasonic vision 2Health News:Mini motor for micromedical applications 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: