The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: June 9, 2016 at 9am to June 10, 2016 at 6pm
Location: Las Vegas, NV
Street: Las Vegas, NV
City/Town: Las Vegas, NV
Website or Map: http://www.mentorhealth.com/c…
Event Type: seminar
Organized By: Netzealous -MentorHealth
Latest Activity: May 17, 2016
This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and 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, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources.
It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions.
Location: Las Vegas, NV Date: June 9th & 10th, 2016 and Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON, Las Vegas, NV
(Seminar Fee for One Delegate Without stay)-Price: $1,295.00
Until May 5, Early Bird Price: $1,295.00 From May 6 to June 7, Regular Price: $1,495.00
(Seminar Fee for One Delegate With stay)-Price: $1,695.00
Until May 5, Early Bird Price: $1,695.00 From May 6 to June 7, Regular Price: $1,895.00
NetZealous DBA as MentorHealth
Registration Link - http://www.mentorhealth.com/control/globalseminars/~product_id=200069SEMINAR