FALLS CHURCH, Va., Aug. 27, 2019 /PRNewswire-PRWeb/ -- ICH E6 GCP Interactive Workshops Wednesday-Thursday, Nov.
Has a risk assessment been correctly instituted at both the system and clinical trial levels?
Have vendors beens qualified correctly?
FDAnews has teamed up with Technical Resources International Inc. to present three days of hands-on workshops aimed at helping attendees understand and comply with ICH E6 (R2) rules. Regardless of where one fits on the clinical trials spectrum, one or both of these workshops is sure to be a right fit.
Course 1 (Two Days) How to Build a Sponsor Risk Management Program Wednesday-Thursday, Nov. 13-14, 2019
Trial sponsors now must institute risk assessment at both the system and clinical trial levels. Has a program been established yet? Is the company maintenance program complete? If not, this hands-on, interactive workshop is just the ticket. Prepare to discover:
Course 2 (One Day) Supplier/Vendor/Contractor Qualification Friday, Nov. 15, 2019
The updates to ICH E6 (R2) require vendor qualification. Has a process been formalized and documented? Are there back-up vendors in place in the event something goes wrong for all the critical supplies? How fast are vendors qualified? During this one-day workshop attendees will learn a systematic approach to ensure all vendors and suppliers are able to perform to company standards.
The leader, Dr. Susan Leister, Director-QA of Technical Resources International, is a seasoned veteran of the clinical trial wars. She'll walk attendees through key elements of quality and supply agreements, and highlight challenges in the vendor qualification process and how to resolve them. Among the specifics she'll cover:
Getting new drugs to market is too important to leave to chance. Make sure all the i's are dotted and all the t's are crossed. These workshops get one where one needs to be ... in a hurry.
Meet Your Presenter Dr. Susan Leister, Director-QA of Technical Resources International, boasts 20-plus years of industry experience and holds CQA and CSSBB certifications from American Society for Quality. She serves on the ASQ Section 509 Executive Committee and served as a 2012 and 2013 Maryland Performance Excellence Award Examiner and a 2013 ASQ International Team Excellence Award Judge. She has served as a part-time faculty member of the University of Phoenix Undergraduate and Graduate School of Business for the past five years.
Who Will Benefit These workshops are aimed at every sector of the clinical trials world — drug and biologics makers; trial sponsors, trial sites and CROs; academic medical centers and IRBs — and the individuals who make trials happen:
Webinar Details: ICH E6 GCP Interactive Workshops Wednesday-Thursday, Nov. 13-14: How to Build a Sponsor Risk Management Program Friday, Nov. 15: Supplier/Vendor/Contractor Qualification Program Presented by FDAnews and Technical Resources International, Inc. Wednesday-Friday, Nov. 13-15, 2019 • Philadelphia, PA https://www.fdanews.com/cwiche6gcp
Tuition: Early Bird Pricing: Course 1 & 2 - $1,947.00 (available until Oct. 11, 2019) Early Bird Pricing: Course 1 - $1,597.00 (available until Oct. 11, 2019) Early Bird Pricing: Course 2 - $797.00 (available until Oct. 11, 2019)
Regular Pricing: Course 1 & 2 - $2,197 (after Oct. 11, 2019) Regular Pricing: Course 1 - $1,797 (after Oct. 11, 2019) Regular Pricing: Course 2 - $897 (after Oct. 11, 2019) Significant team discounts are available.
Easy Ways to Register: Online: https://www.fdanews.com/cwiche6gcp By phone: 888-838-5578 or 703-538-7600
About CenterWatch: Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials. As a pioneer in publishing clinical trials information, CenterWatch was the first Internet site to publish detailed information about active clinical trials that could be accessed by patients and their advocates.
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