Quality Validation 360 Inc
Email: amarinelli@qualityvalidation360inc.com; amarinelli360@gmail.com
Quality/Quality Engineering Function
QV360 can provide the following services but not restricted to the following:
(1) Support your Change Control [Trackwise], CAPA's
(2) Remediation, QA Management, Approving of protocols
(3) Investigational [Root Cause Analysis]
(4) Auditing [Internal/External], Batch Release
(5) Defending in front of FDA at the request of the client
(6) Quality Operation/Quality Assurance Subject Matter Expert
(7) Coaching/Mentoring
Quality Validation 360 Services
At Quality Validation 360 Inc, we take care to provide our customers high quality services personalized for their unique needs. We are available to take your request 24 hours a day, 7 days a week.
Validation Function
QV360 can provide validation services [Writing/executing, Final Reporting and Project Close-out] such as but not restricted to:
(1) Equipment /Process/Cleaning validation
(2) Computer/Software Validation and Control Sstems validation
(3) User Requirement Specification, Functional/Design Specification
(4) Turn-over/Hand-over package compilation/organization
(5) Capital Projects
(6) Validation Subject Matter Expert
Project Management
QV360 can provide project management services to suite your needs from small scale to large scale manufacturing facilities under large or small Capital Projects while using science risk based approaches to mitigate the risks for regulatory violations when your company is being inspected by the FDA, EMA, WHO, KFDA, CFDA or other applicable regulatory agencies.
