Integrating the New Standard and
What You Really Need to Know to Comply

Monday, Oct. 30, 2017 · 1:30 p.m. - 3:00 p.m. EDT

The ICH E6 R2 GCP guideline has major impact on everyone from clinical trial principal investigators to drug and biologics makers. But a year after its promulgation, clinical trials professionals still struggle with its provisions.

The quality management requirement of Sec. 5 and the risk management provisions, are particularly troublesome — so much so that FDAnews has called on an expert to clear things up.

Mark your calendar for an informative new webinar from FDAnews featuring Dr. Susan Leister, a leader in quality control matters. In just 90 minutes, she’ll address your most pressing questions and set you on a path to full compliance. She’ll cover:

  • Major changes in Sec. 5.0 and how they may affect you

  • Specific challenge areas: sponsor quality management system, software validation, risk management

  • The hidden implications of certain Sec. 5.0 changes

  • A path to full and effective compliance

  • And much more

But good clinical practice cuts across many areas of interest — Rx and biologics, academic medical centers, IRBs, CROs, clinical trial sponsors and sites. It pays to spread the word to colleagues and contacts, and invite them to take part in a conference room or auditorium. It costs nothing extra; one low registration fee covers an unlimited number of participants per site.

This webinar delivers an immediate payoff in smoother compliance, greater efficiencies, and swifter FDA approvals even. You miss it at your peril. Register now.

Who Will Benefit

  • Medical Affairs
  • Clinical Operations
  • Regulatory Affairs/Compliance
  • Publications Directors
  • Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure
  • Global Clinical Safety and Pharmacovigilance
  • Clinical Quality Auditors
  • QA/QR/QC

Webinar plus Audio Recording/Transcript
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Webinar only
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24/7 Encore plus Audio Recording/Transcript
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24/7 Encore Presentation
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Meet Your Presenter

Dr. Susan Leister

Director-Quality Assurance
Technical Resources International

Dr. Susan Leister, Director-Quality Assurance for Technical Resources International, boasts more than 20 years of industry experience. She holds ASQ certifications as a CQA and a CSSBB; serves on the ASQ Section 509 Executive Committee as the Section Chair; and served as a Maryland Performance Excellence Award Examiner for four years. She teaches in the University of Phoenix Undergraduate and Graduate School of Business.

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA.

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