FDAnews Announces: "Clinical Quality Assurance: Roles and Responsibilities for Auditors and Managers," Aug. 22-23, 2017, Arlington, VA

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This one-of-a-kind 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.

Clinical Quality Assurance Aug 2017

Clinical Quality Assurance Aug 2017

Clinical Quality Assurance:
Roles and Responsibilities for Auditors and Managers
**Presented by FDAnews and MSceppa Consulting **
Aug. 22-23, 2017 – Arlington, VA
http://www.fdanews.com/cqa

Increased FDA scrutiny and growing demands to track and report adverse events place even greater pressure on aclinical quality assurance program. Get ready for tougher questions from FDA investigators and ensure that clinical trials meet the highest quality standards.

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.

She’ll walk 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

Throughout the workshop, attendees will also participate in invaluable Interactive Exercises that will make them feel like they're engaged in an actual inspection, giving them priceless hands-on experience that will serve them well for years to come.

Finally, attendees will walk away after two days with valuable tools they'll 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

Don't miss out on this unique opportunity to learn to confidently conduct comprehensive and effective CQA audits.

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:
Clinical Quality Assurance:
Roles and Responsibilities for Auditors and Managers
**Presented by FDAnews and MSceppa Consulting **
Aug. 22-23, 2017 – Arlington, VA
http://www.fdanews.com/cqa

Tuition:
Early Bird (until July 88): $1,597
Regular Price: $1,797
Significant team discounts are available.

Easy Ways to Register:
Online: http://www.fdanews.com/cqa
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.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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