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:11/25/2015)... LYON , Frankreich, November 25, 2015 ... hat heute bekanntgegeben, dass sie eine Lizenz für das ... Inserm, Poxel, CNRS, UCBL und ENS-Lyon innehaben, an Enyo ... 2009 von FUI AAP8 ins Leben gerufenen und von ... NATHEB-Programms wurde FXR als ein Behandlungsziel für HBV identifiziert, ...
(Date:11/24/2015)... 24, 2015  Natera, Inc. (Nasdaq: ... testing and the analysis of circulating cell-free ... at the 27 th  Annual Piper Jaffray ... p.m. ET.  Matthew Rabinowitz, Ph.D., CEO of Natera, ... activities and financial outlook.  ...
(Date:11/24/2015)... COMMACK, New York , 24. November ... Hersteller des Avery Breathing Pacemaker Systems, ist ... Ph.D., als Clinical Consultant bekannt geben zu ... -->   --> ... Stockholm (Schweden). Von 1984-1986 ...
Breaking Medicine Technology:
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... will provide scholarships for people struggling with eating disorders as a result of ... the second annual event, held at Fox Run Golf Club in Eureka, will ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... that it has undertaken significant expansion of its current state of the art ... part of PharmaTech’s strategy to increase its manufacturing capacity as well as to ...
(Date:11/25/2015)... ... November 25, 2015 , ... Bcureful—a ... (TSC), as well as raising public awareness of the disorder while helping to ... third donation of $35,000 to bolster progress at the Tuberous Sclerosis Complex Center ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... ... treatment, is offering lower prices in an early celebration of the early holiday ... promotional price of $29.95 each (normally $33.95 ea). Black Friday promotional pricing is ...
(Date:11/24/2015)... , ... November 24, 2015 , ... Dr. Todd S. ... offer laser services to many of his patients. Dr. Afferica now uses the BIOLASE ... reduce the amount of time the doctor uses other traditional cutting tools, such as ...
Breaking Medicine News(10 mins):