The meanings and regulatory requirements of the terms "verification鈥� and "validation鈥� are often confusing to engineers and even some regulatory professionals. Operations managers are even less well versed. FDA regulations as well as European standards such as ISO 13485:2003 require both verification & validation documentation throughout these regulations and standards. The terms apply to design control, process control and others. Numerous warning letters on this subject has been issued by FDA to well known manufacturers. Verification and validation also appear in the "essential requirements鈥� in MDD 93/42/EEC needed for CE marking medical devices in the European Union. Good engineering practices in all industries benefit from well executed verification and validation studies.
Areas Covered in the Session:
路Verification & validation types
路顿别蹿颈苍颈迟颈辞苍蝉
路Design control
路Process control
路础辫辫濒颈肠补迟颈辞苍
路Consequences of poor verification & validation
路Why verification & validation makes good business sense
Who will benefit: (Titles)
Companies wishing to understand the risks and complications involved with the application of sound verification and validation principles will gain a better understanding of the differences and benefits. Employees who will benefit include:
路Quality & Regulatory Professionals
路Manufacturing & Design Engineers
路Marketing Product Managers
路Corporate & Operations Executives
Areas Covered in the Session:
路Verification & validation types
路顿别蹿颈苍颈迟颈辞苍蝉
路Design control
路Process control
路础辫辫濒颈肠补迟颈辞苍
路Consequences of poor verification & validation
路Why verification & validation makes good business sense
Who will benefit: (Titles)
Companies wishing to understand the risks and complications involved with the application of sound verification and validation principles will gain a better understanding of the differences and benefits. Employees who will benefit include:
路Quality & Regulatory Professionals
路Manufacturing & Design Engineers
路Marketing Product Managers
路Corporate & Operations Executives
