Clinical Quality Assurance and Management Policy: Two Case Histories

Written by on Monday, April 2nd, 2007

The event Clinical Quality Assurance and Management Policy: Two Case Histories will be held on Wednesday, April 18, 2007 from 10 to 11:30 a.m. by audio conference.  The event will look at two different case studies on clinical trials and what went wrong and how to avoid it, addressing the following:

  • What corporate decisions occurred?

  • Why did one site close down in response to the FDA enforcement action?

  • Why does corporate management not share the clinical research or the regulatory perspective?

  • What is the required corporate management CQA interface?

  • Where and why did it fail?

  • FDA sponsor obligations – what are they?

  • What is the sponsor’s liability and exposure for FDA enforcement action?

  • How do the concepts of misconduct, fraud, and sponsor due diligence impact the FDA application of enforcement actions?

  • How can CQA enable corporate management to empower the CQA function?

  • What is the role of clinical project management and regulatory affairs in ensuring FDA compliant sponsor corporate management decisions?


© 2008-2015 The Prinz Law Office. All rights reserved.

The Prinz Law Office | Silicon Valley, CA | Los Angeles, CA | Orange County, CA | San Diego, CA | Atlanta, GA | Tel: 1.800.884.2124

Mailing Address: 117 Bernal Rd., Suite 70-110, San Jose, CA 95119; Silicon Valley Office: San Jose- 2033 Gateway Place, Suite 500, San Jose, CA 95110 (408)884-2854; Los Angeles Office: 3110 Main St., Building C, Santa Monica, CA 90405 (310)907-9218; Orange County Office: 100 Spectrum Center Drive, 9th Floor, Irvine, CA 92618 (949)236-6777; San Diego Office: 4455 Murphy Canyon Road, Suite 100, San Diego, CA 92123 (619)354-2727 Atlanta Office: 1000 Parkwood Circle, Suite 900, Atlanta, Georgia 30339 (404)479-2470

Biotech Transactions Lawyer & Attorney: Serving Silicon Valley, San Jose, San Francisco, San Diego, Los Angeles, Orange County, Irvine, Anaheim, Santa Monica, Silicon Beach, Atlanta. Licensed in California and Georgia.