The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements.
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA.
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America.
NIST’s mission is to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life.
The 10th annual AMS Summit brings together senior Manufacturing experts from America's leading companies. Speakers from Toyota, Anheuser-Busch InBev, Ford Motor Company, PaxVax, Interface, Kinamed Corporation and many more will share insights into their operations.
Getting the right start when you’re implementing IoT in your business is critical. Our IoT readiness workshop is designed by industry experts who will help you identify, plan, implement and assess the outcome of your IoT project–whether you’re starting your first or you’ve already done several.
Getting the right start when you’re implementing IoT in your business is critical. Our IoT readiness workshop is designed by industry experts who will help you identify, plan, implement and assess the outcome of your IoT project–whether you’re starting your first or you’ve already done several.