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Cost-effective auditing: Making the most of the time on-site

Event Details

Cost-effective auditing: Making the most of the time on-site

Time: February 20, 2014 from 10am to 11am
Location: Online Event
Street: 2600 E. Bayshore Road
City/Town: Palo Alto
Website or Map: http://www.complianceonline.c…
Phone: +1-650-620-3915
Event Type: clinical
Organized By: ComplianceOnline
Latest Activity: Feb 6, 2014

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Event Description

This training on clinical audit will teach attendees how to prepare for audit and ensure readiness at all times.

 

Why Should You Attend:

How effective are your clinical trial audits? Can you rapidly identify major issues that could negatively impact your ability to manufacture products? Audits can be challenging – there can be an adversarial undercurrent even before it starts. And rightfully so – there can be a lot on the line, such as continued business relationships and continued revenue streams. When to start an audit program is always a concern, especially in the early stages of product development – whether it is performed on the premises or off-site.

By attending this webinar, the participants will learn how to prepare for a clinical trial audit so that one can maximize time and information gathering time during the audit. It will teach the attendees to manage the audit if participants show defensive attributes. Learn how to “pull the thread” and find out if what you see is reality.

Assessing the significance of a finding, in the context of the operation and how to effectively communicate the concern can be challenging – be prepared to adjudicate the significance of each finding at the wrap-up meeting.

Areas Covered in the Webinar:

  • How to prepare for the audit
  • To use a checklist or not – that is a question
  • The tour
  • Records: how to select and how to review
  • Procedures and quality systems – maximizing everyone’s time
  • Avoiding common pitfalls
  • The wrap-up
  • The Report

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

  • Healthcare providers interested in exploring the field of Clinical Research
  • New Clinical Research Coordinators (1-2 years)
  • New Principal Investigators
  • Administrative managers in charge of Clinical Research
  • Regulatory Compliance Associates and Managers

Instructor Profile:

Janet Rose Rea, is a consultant for the biopharmaceutical industry and the principal in her company, QARA Services, LLC. Ms. Rea was also a faculty member at the U of W, providing a current industry perspective in the BioMedical Regulatory Affairs, where she had been a frequent lecturer since 1999. She held the position of Vice President, Regulatory Affairs and Quality at Poniard Pharmaceuticals (previously NeoRx), from 2008 – 2010 and AVI BioPharma from 2003 – 2008. She was also a corporate officer for both organizations.

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