Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements
Added by Referral on 2019-04-17
Conference Dates:
Start Date: 2019-06-05Last Day: 2019-06-05
Deadline for abstracts/proposals: 2019-06-03
Conference Contact Info:
Contact Person: Ashutos SwainEmail: [email protected]
Address: 2479 E. Bayshore Road Suite 260, Palo Alto, CA, 94303, United States
Tel: 8887172436
Fax: [email protected]
Conference Description:
Developing a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management for development of meaningful product validations.FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based V&V planning.