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The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
Please  note that Quality College workshops require separate registration.

Please review the Safety Rules and Guidelines.
Monday, April 9 • 8:00am - 5:00pm
Workshop 9 - GCP 202: Hot Topics & Industry Trends (1 day)

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RQAP re-registration units: 2 GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This interactive workshop will provide experienced GCP QA professionals with additional skills and techniques to expand their knowledge and implementation of important new topics and trends in the QA field. This session has been designed to provide best practices and audience participation activities in employing effective interview techniques, preparing for upcoming Device GCP changes in the EU, understanding the MDSAP program and upcoming organizational and outreach efforts by US FDA. In addition to these topics, this session will also provide the regulatory perspective as it relates to the current status of GCPs as experienced in the global community.

Objectives
At the end of the course, the participants shall be able to: 
  • Apply more effective interview techniques during audits
  • Describe important upcoming changes to Device GCPs in the EU
  • Discuss pros and cons of the MDSAP program
  • Explain FDA re-organization and outreach efforts (FDA Rep to be invited)

Target Audience
GCP professionals with 2 or more years of experience.

Agenda
  • Overview of Quality Management in Clinical Trials E6(R2) focus
  • Understanding the MDSAP program
  • Preparing for EU Regulatory Device GCP changes
  • Employing Effective Interview Techniques When Auditing
  • FDA Re-organization and Outreach Activities Update


Speakers
avatar for Chrissy Cochran

Chrissy Cochran

Director, OBIMO, Food and Drug Administration
Chrissy J. Cochran, PhD is Director of the Office of Bioresearch Monitoring Operations at the FDA, and is responsible for working with each of FDA’s product centers to establish and manage the BIMO program. She previously led the Division of Enforcement and Postmarketing Safety... Read More →
avatar for Glenda Guest

Glenda Guest

President, Assured of Quality Consulting & Training
Glenda Guest CCRA, RQAP-GCP, TIACR has an extensive background in the clinical research industry having worked as a monitor, project manager, data management coordinator, database programmer, quality assurance auditor and senior trainer since joining the clinical research profession... Read More →
avatar for Lee Truax-Bellows

Lee Truax-Bellows

President, CRO, NCRA
Lee Truax Bellows, RQAP-GCP, CCRALee has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a GCP Quality Auditor, Trainer, and Project Manager. Lee has been involved in regulated research for the past 28 years... Read More →


Monday April 9, 2018 8:00am - 5:00pm
Platinum 9

Attendees (7)