ICH E6 R2 changed the risk management requirements for programs. Do the current programs pass muster?
FALLS CHURCH, VA. (PRWEB) OCTOBER 04, 2019
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
Early bird pricing for ICH E6 GCP Interactive Workshops ends on Oct. 11.
Has a risk assessment been correctly instituted at both the system and clinical trial levels?
Have vendors been 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:
- How to establish a program step-by-step
- Critical elements of starting a program: A walk-through
- How to conduct risk assessment at both system and clinical trial levels
- Evaluating the risks: Company options
- Risk mitigation and reporting strategies
- Common pitfalls and how to sidestep them
- And much more!
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:
- Requirements for a compliant vendor/supplier/contractor qualification program
- Applying a risk-based approach to the supplier/vendor selection process
- Understanding supplier assessments, pre-approval and re-assessment
- Quality agreements and supplier agreements
- How to handle vendor problems up to vendor disqualification
- And more besides!
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.
Early bird pricing ends on Friday, October 11.
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:
- QA/QC managers and staff
- RA managers and staff
- Compliance auditors
- Manufacturing managers
- Project managers
- Senior managers
- Supply chain and logistics managers
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.
