Date :
Place : United States, Las vegas,nv
Website :http://www.globalcompliancepanel.com/seminar
Contact Person:Event Manager
Description:
This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer & tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, & PQs, or their equivalents per ASTM E2500, all against a background of limited.Deadline for abstracts/proposals : 14th October 2015
Organized By :NetZealous LLC, DBA GlobalCompliancePanel
Keynote Speakers : John E Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been descr
Conference Highlights :Day 1 Schedule: Lecture 1: Master Validation Planning and the Master Validation Plan(s) Lecture 2: Product, Process / Equipment Hardware V&V Lecture 3: Product / Device V&V Lecture 4: Software V&V Lecture 5: Quality Management System / 21 CFR Part 11 V&V Lecture 6: Summary of morning discussion Lecture 7: Group activity on the MVPs Lecture 8: Review of group activity and Q&A Day 2 Schedule: Lecture 1: Software V&V documentation "model" Lectur
Venue :Venue: Hilton Grand Vacations Suites at the Flamingo Hotel: Hilton Grand Vacations Suites at the Flamingo 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109-4313, USA Date: October 15th & 16th, 2015 Time: 9:00 AM to 6:00 PM Price: $1,695.00 (Seminar for One Delegate) Register now and save $200. (Early Bird) Until August 31, Early Bird Price: $1,695.00 From September 01 to October 13, Regular Price: $1,895.00 Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone: 800-447-9407 Fax: 302-288-6884 [email protected] http://www.globalcompliancepanel.com Event Registration Link: https://goo.gl/Rxmg70
Check the event website for more details.