Dinner Short Course: Quality by Design in Clinical Research: Is This Only for the Protocol?

NEEDHAM, Mass. - April 24, 2015 - PRLog -- When: June 2, 2015 (6:00-8:30 pm)
Where: Omni Parker House, Boston, MA

In the past few years, Quality by Design (QbD) for clinical trials has been communicated and talked about for protocol development and execution. However, translating this QbD approach into “building in quality for the business,” that is increasingly expected of the industry by regulatory agencies, is rarely shared for the “how do I do this?” because organizations state “I believe we are doing this already.” This workshop will de-code and translate QbD and quality for the research enterprise with examples and interactive activities that will solidify the concepts and framework presented for use within any organization. I will discuss:

·         Critical first step: defining quality

·         QbD: defined and simplified

·         What are QbD and Quality Management Systems (QMS)? How do they relate to each other?

·         How do I know if my organization “has these in place”?

·         What are “critical to quality” and “critical control points” in QbD, and why are they important?

·         Business practices to QbD principles and methods, and approaches to impart QbD where needed

·         Going beyond plans and checklists for quality

·         Who is involved and responsible for review?

·         Strategies for effective implementation

·         Effective training of personnel

Instructor:
Liz Wool, RN, BSN, CCRA, CMT, President and CEO, QD-Quality and Training Solutions, Inc.

Dinner and short course materials will be provided.

For more information, visit http://www.clinicaltrialsummit.com.

How to Register:
Web: https://chidb.com/reg/ctl/reg.asp
Call: 781-972-5400
Email: reg@healthtech.com

About Clinical Trial Oversight Summit

Cambridge Healthtech Institute's fourth annual Clinical Trial Oversight Summit will feature four co-located conferences covering best practices and recent trends relevant to clinical research monitoring, auditing, clinical quality assurance, site management, and vendor oversight. This three-day summit will brings together 250+ highly targeted decision makers  and include presentations, case studies, interactive breakout discussion groups, dinner short courses, and networking opportunities. Themes throughout will include risk-based approaches to clinical trial management, implementing quality systems-based approaches to GCP compliance, ensuring reliable study data, responding to the evolving regulatory landscape, and preparing sites and clinical research partners for inspection-readiness. http://www.clinicaltrialsummit.com

About Cambridge Healthtech Institute (CHI)

Cambridge Healthtech Institute (CHI), founded in 1992, is the industry leader in providing superior-quality scientific information to eminent researchers and business experts from top pharmaceutical, biotech, and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Conferences, Barnett Educational Services, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners, Cambridge Healthtech Media Group, The Knowledge Foundation, and OpenHelix.http://www.chicorporate.com