Navigation Links
FDAnews Announces Clinical Quality Assurance Workshop

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


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 is essential to assuring completion of everything that needs to be done
  • Conduct the audits — what do you do and what interviewing skills are needed
  • Compose the site visit audit report — writing it is sometimes the hardest thing to accomplish
  • Evaluate the audit findings and implement corrective actions — once the report is written the audit is not over
  • Master FDA inspections and avoid the top five GCP violations

Who Will Benefit

  • Clinical quality assurance managers and auditors
  • Clinical site directors
  • Clinical research associates/coordinators
  • Regulatory affairs
  • IRB administrators

Register today

Meet Your Instructor

Michelle Sceppa , principal and founder of MSceppa Consulting, has more than 25 years of experience in quality assurance and regulatory compliance in the pharmaceutical and medical device industries. As a lead auditor, she has conducted and managed more than 300 internal and external audits for drug, biologics and medical device firms in the U.S. and Europe.

Ms. Sceppa has implemented and managed preclinical, clinical and manufacturing quality assurance programs for numerous clients and has knowledge in the details of compliance with all U.S. federal regulations, including: good laboratory practice (GLP), good clinical practice (GCP) and good manufacturing practice (GMP) for drugs, biologics and medical devices.

Ms. Sceppa is also certified in the Q7A regulations for the manufacture of active pharmaceutical ingredients. Since 2002, she has been a faculty member of the Parenteral Drug Association's (PDA) Training and Research Institute (PDA-TRI) in Baltimore, MD.

Clinical Quality Assurance
Roles and Responsibilities for Auditors and Managers
**Presented by MSceppa Consulting and FDAnews**
Feb. 27-28, 2013 – Raleigh, NC

TUITION: $1,797 per attendee

4 Easy Ways to Register
By phone:  888-838-5578 or 703-538-7600
Fax:          703-538-7676
Mail to:      FDAnews
                     300 N Washington St
                     Ste 200
                     Falls Church VA USA 22046

Media Contact: Jeff Grizzel ,  FDAnews, 703-538-7668,

News distributed by PR Newswire iReach:


Copyright©2012 PR Newswire.
All rights reserved

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:
(Date:9/18/2017)... , Pa. and KALAMAZOO, Mich. , Sept. ... Penn. , and OptiMed Specialty Pharmacy of ... partnership to offer a strategic hub service that expedites ... highly sought-after personal spirometer, Spiro PD 2.0, and wellness ... A spirometer is a medical device used to measure ...
(Date:9/12/2017)... 12, 2017   EcoVadis , the leading platform for environmental, social ... annual edition of its Global CSR Risk and Performance Index. The report ... based on Scorecard Ratings that analyzed nearly 800,000 data points across the ... ... ...
(Date:9/9/2017)... ... DC ... th – Monday, September 18 th .The Brain Tumor Foundation (BTF) ... to the public.Where:  BTF,s Mobile MRI Unit – ... NW, Washington, D.C.What:BTF brings its nationwide initiative, the Road to Early Detection ...
Breaking Medicine Technology:
(Date:10/13/2017)... RIDGE, N.J. (PRWEB) , ... October 13, 2017 , ... ... annual Holly Day Market. Featuring a collection of specialty vendors and unique items from ... of personalized and quality-focused health and wellness services offered by the VNA. The ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... giving viewers the lowdown on sciatica in a new episode of "Success Files," ... on current events and innovation and investigates each subject in-depth with passion and ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare Compliance (FHC), an ... showcase a range of technology and learning solutions at the 68th Annual American ... to be held October 14–18, 2017 at the Mandalay Bay Resort in Las ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( ... the introduction of an innovative new design of the shoulder pad. The shoulder ... maximum comfort while controlling your pain while using cold therapy. By utilizing ice and ...
(Date:10/12/2017)... LOS ANGELES (PRWEB) , ... October 12, 2017 ... ... of Parsa Mohebi Hair Restoration, has recently contributed a medical article to the ... doctors, on Dr. Mohebi’s article spotlights the hair transplant procedure known as ...
Breaking Medicine News(10 mins):