FDAnews Announces: Risk-Based Clinical Quality Assurance: Train Your Auditors Like the FDA Does, June 18-19, 2014, Bethesda, MD

This Risk-Based Clinical Quality Assurance workshop teaches proven tips and tricks for training auditors to spot even the slightest violations, before the FDA does. This interactive workshop will teach attendees how to develop risk-based CQA processes and compliance readiness.

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Clinical Quality Assurance

Clinical Quality Assurance

“The working sessions were great. I liked hearing about Michelle’s experiences. I also like the ability to ask questions throughout the workshop.” -- Consultant, QA, Eli Lilly

Falls Church, VA (PRWEB) May 06, 2014

Risk-Based Clinical Quality Assurance:
Train Your Auditors Like the FDA Does
**Presented by MSceppa and FDAnews**
June 18-19, 2014 – Bethesda, MD
http://www.fdanews.com/CQABethesda

In two action-packed days, attendees will learn what FDA investigators use to evaluate sites. This interactive workshop will teach attendees how to develop risk-based CQA processes and compliance readiness.

Attendees will benefit from the first-hand knowledge and experience of workshop leader and expert Michelle Sceppa, a 25-year quality assurance and regulatory compliance veteran in both the pharmaceutical and medical device industries.

Some of the most common Form 483 citations issued to clinical sites include:

  • Failure to follow protocol: A clinical investigation was not conducted in accordance with the signed statement of the investigator
  • Case history reports that are inaccurate or inadequate
  • Failure to obtain consent forms or the consent forms were not approved, signed or dated

Any one of these could derail a project, costing millions in lost revenue. On June 18-19 in Bethesda, MD, auditing veteran Michelle Sceppa walks attendees step by step through such details as:

  • A review of how FDA conducts clinical inspections and the top 5 GCP violations
  • How to write GCP audit SOPs: What elements to include
  • Writing a central laboratory audit SOP and why this SOP is needed
  • Selecting sites to be audited: Creating a master audit plan and how to make sure it is met
  • Audits of a central laboratory: Why lab data and testing are a critical component of the clinical study

Finally, attendees walk away after two days with valuable tools they will be able to put to use immediately:

  • Slides from PowerPoint presentations
  • Case review worksheets
  • Interactive exercise worksheets
  • SOPs, forms, templates for CQA audits: site, CRO and central laboratory
  • Copies of applicable FDA/ICH regulations and guidances

Meet the Presenter
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, biologic and medical device firms in the US and Europe.

Who Will Benefit

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

Conference Details
Risk-Based Clinical Quality Assurance:
Train Your Auditors Like the FDA Does
**Presented by MSceppa and FDAnews**
June 18-19, 2014 – Bethesda, MD
http://www.fdanews.com/CQABethesda

Tuition: $1,797

Easy Ways to Register
Online: http://www.fdanews.com/CQABethesda
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.