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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.
Friday, April 13 • 8:00am - 5:00pm
Workshop 18 - GCP 201: Advanced Training (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 session will provide experienced GCP QA professionals with advanced GCP QA tools to incorporate into how they perform audits, training and GCP support within their roles. This session has been designed to provide best practices and audience participation activities that highlight the experience of the presenters and the attendees.

Objectives
At the end of the course, the participants shall be able to: 
  • Incorporate presented professional development and advanced audit and training techniques into their roles.
  • Incorporate current regulations and guidelines that impact GCP into their roles.
  • Understand and implement a quality management system approach into their roles.

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

Agenda
  • 8:00 - 8:30 Welcome, Housekeeping, Agenda Review and Introductions
  • 8:30-9:15 Components of a Quality Management System (QMS) 
  • 9:15-10:00 FDA’s Approach to a Quality Management System Approach in GCPs
  • 10:00 - 10:15 Break
  • 10:15 - 11:00 EU’s Approach to Quality Management System Approach in GCPs
  • 11:00 - 12:00 Practical Application of a Quality Management System (QMS) Approach Within the GCP Arena
  • 12:00 - 1:00 Lunch
  • 1:00 - 2:00 GCP Risk Management
  • 2:00 - 3:00 Root Cause Analysis and CAPA Under GCPs
  • 3:00 - 3:15 Break
  • 3:15-4:30 Additional Strategies for Planning, Conducting and Reporting Audits Under a QMS Approach
  • 4:30 - 5:00 Q&A

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 Cheryl McCarthy

Cheryl McCarthy

Associate Director, Biogen
Cheryl McCarthy has over 20 years industry experience in a regulated environment. Her GCP experience includes the development and management of Quality Management Systems, Audit Programs and Computer System Validation Programs. She is currently at Biogen in the role of Associate Director... Read More →
avatar for Vaska Toné

Vaska Toné

CEO / Founder, LaVaPharm Consulting LLC
Vaska Tone is an independent international QA consultant and the founder of LaVaPharm Consutling with offices in the US and Europe. She has been in QA since 1994 performing global audits from GLP through to Post-Marketing PV audits. She is passionate about continual learning and speaks... 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 →


Friday April 13, 2018 8:00am - 5:00pm
Platinum 1&2

Attendees (8)