The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: January 22, 2018 at 9am to January 23, 2018 at 6pm
Location: St. George UT
Street: St. George UT
City/Town: St. George UT
Website or Map: http://www.globalcompliancepa…
Event Type: regulatory, and, compliance, seminars
Organized By: NetZealous DBA as GlobalCompliancePanel
Latest Activity: Nov 15, 2017
Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
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: St. George UT Date: January 22nd & 23rd, 2018 and Time: 9:00 AM to 6:00 PM
Venue: Hilton Garden Inn St. George 1731 South Convention Center Drive, Saint George, Utah, 84790, USA
Price: $1,295.00 (Seminar Fee for One Delegate)
Register now and save $200. (Early Bird)
Until January 01, Early Bird Price: $1,295.00 From December 31 to January 20, Regular Price: $1,495.00
Register for 5 attendees Price: $3,885.00
$6,475.00 You Save: $2,590.00 (40%)*
Register for 10 attendees Price: $7,122.00
$12,950.00 You Save: $5,828.00 (45%)*
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NetZealous LLC DBA GlobalCompliancePanel
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