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:9/30/2014)... 30, 2014  Wrightington, Wigan ... MDRX ) are delighted to announce WWL,s ... new health information system. The system will be implemented ... the way WWL delivers healthcare in the future. ... record of on-time and on-budget system implementations as well ...
(Date:9/30/2014)... Sept. 30, 2014 This study provides ... imaging informatics solutions including nuclear imaging informatics, PET ... The study assesses the size of the market ... 2013, and projects future growth based on the ... dynamics taking place in the broader markets for ...
(Date:9/30/2014)... , Sept. 30, 2014  Decision Resources Group finds ... Brazil , Russia ... China (BRIC) will see robust expansion as ... favored over surgical procedures. Although revenues will be somewhat ... challenges, prolonged device approval times and demand for low-cost ...
Breaking Medicine Technology:Wrightington, Wigan and Leigh NHS Foundation Trust selects Allscripts Sunrise 2Wrightington, Wigan and Leigh NHS Foundation Trust selects Allscripts Sunrise 3Wrightington, Wigan and Leigh NHS Foundation Trust selects Allscripts Sunrise 4Analysis of the US Molecular Imaging Informatics Market 2Analysis of the US Molecular Imaging Informatics Market 3Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 2Brazilian, Russian, Indian and Chinese Markets for Peripheral Vascular Devices Will See Strong Expansion Through 2023 3
... announced today that it has significantly upgraded its ... designed for its growing supply chain organization.  The ... innovative flexible architecture which will enable extensive tracking ... monitoring.  It is designed explicitly for ease of ...
... Each year, one of every 150 two-year-olds visits an ... medication overdose, most often after finding and eating or ... caregivers about safe medication storage and what to do ... Consumer Healthcare Products Association Education Foundation and ...
Cached Medicine Technology:Marken Announces Its New Logistics Operating System: Maestro™ 2Many Young Children Overdosing From Medicines at Home 2Many Young Children Overdosing From Medicines at Home 3
(Date:10/1/2014)... 2014 Farmington Company today announced ... mission and visual identity helping brokers, consultants and ... them to create greater benefit communication synergies. They ... on empowering customers to better leverage Farmington Company’s ... jewel of the rebrand is the refreshed tagline: ...
(Date:10/1/2014)... Maine (PRWEB) October 01, 2014 Between ... disorders in the U.S., according to figures from the ... Related Diseases Association (AARDA), and many of them have ... chance of having undiagnosed celiac disease. Gluten Free ... raise awareness of undiagnosed celiac disease by publishing a ...
(Date:10/1/2014)... Canada (PRWEB) October 01, 2014 Anti ... removal and skin rejuvenating destination of choice, is announcing ... from October through to December. , “We’re doing this ... as possible to our top skin clinic in Toronto,” ... “We do so much at Anti Aging Clinic, including ...
(Date:10/1/2014)... October 01, 2014 Nordic Naturals ... a very special cause. The campaign—“Buy One Bottle. ... Paws for Veterans, a nonprofit organization that helps ... rescuing shelter dogs that would otherwise face euthanasia. ... products will support monthly donations of Nordic Naturals ...
(Date:10/1/2014)... 01, 2014 Today marks the final ... Art Institute in Oxnard and Woodland Hills, Calif., is ... mouth rehabilitation training. , “Speaking to this group of ... procedures to get the help and care they deserve,” ... repairing previous dental work, providing cosmetic dentistry, correcting bite ...
Breaking Medicine News(10 mins):Health News:Farmington Company Launches Rebrand and New Positioning 2Health News:Informative New Blog Series Underscores Link Between Celiac Disease and Other Autoimmune Disorders 2Health News:Informative New Blog Series Underscores Link Between Celiac Disease and Other Autoimmune Disorders 3Health News:Anti Aging Clinic, the GTA’s Premier Provider of Anti Aging Treatments, Announces Deal on Units of Botox 2Health News:Nordic Naturals® Inspires Support for Paws for Veterans -- ‘Buy One Bottle. Help Two Heroes.’ Initiative Kicks Off October 1 2Health News:Internationally Respected Oxnard Dentist Concludes All-on-4™ Dental Implants Training Today 2Health News:Internationally Respected Oxnard Dentist Concludes All-on-4™ Dental Implants Training Today 3Health News:Internationally Respected Oxnard Dentist Concludes All-on-4™ Dental Implants Training Today 4Health News:Internationally Respected Oxnard Dentist Concludes All-on-4™ Dental Implants Training Today 5
... ... a health care professional about different areas of vascular disease. Join us this Tuesday, ... from the Cleveland Clinic. Visit http://www.vdf.org/interactive/ask.php for log-in information. , ... Lakewood, CO (Vocus) April 5, ...
... Dermatologists using Vivacare,s ... help build awareness of this chronic skin condition and the importance of early diagnosis and ... (PRWEB) April 5, ... know it, but the public can now learn more about this chronic skin disorder from ...
... ... own dog food” as contributors collaborate virtually and document their experiences. , ... Emigsville, PA ... systems and data services, today announced their participation in the upcoming publication, Virtual ...
... ... Awareness Month after successful workshop at busy office shows internet entrepreneur stress-reducing benefits of guided ... (PRWEB) April ... tasks throughout the day, which can create a high level of stress. Being aware of ...
... Donate Life America, 43 percent of people are undecided, reluctant ... donated after their deaths. While an improvement over findings ... reported the same, the statistic illustrates a critical need to ... to save the lives of the more than 105,000 adults ...
... stares tempt you to give into your child,s meltdowns, expert ... what? , Parents often have a hard time figuring out ... It doesn,t help matters that kids often have their meltdowns ... restaurant. , Chuck Smith, a Kansas State University child development ...
Cached Medicine News:Health News:Live Online Chats Answer Questions About Vascular Disease 2Health News:Rosacea Awareness Month Honored by Dermatologists Using Vivacare to Deliver Rosacea Patient Education 2Health News:Vasont Systems Contributes Content Management Expertise to New Book on Virtual Collaborative Writing 2Health News:Vasont Systems Contributes Content Management Expertise to New Book on Virtual Collaborative Writing 3Health News:Guided Meditation Made Available to Everyone for Stress Awareness Month 2Health News:Number of Americans willing to donate organs rises, but still not keeping pace with need 2Health News:Number of Americans willing to donate organs rises, but still not keeping pace with need 3Health News:Dealing With Those All-Too-Public Tantrums 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 ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... 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 ...
Medicine Products: