I have a solid experience in validation of processes (DQ, IQ, OQ, PQ) according to the requirements of ISO 15378, ISO 13485, 21 CFR part 820, GMP (Good Manufacturing Practices) and GHTF - Process Validation Guidance.
My experience includes all steps in the validation process:
DQ – Design Qualification
IQ – Installation Qualification
OQ – Operational Qualification
PQ – Performance Qualification
After many years in the plastics industry with production of primary packaging for medicine, I am very experienced in validation of injection and blow molding of plastic parts (injection molding, injection blow molding & blow molding) as well as filling and assembly processes.
During my work as a consultant, I have helped small and large companies to establish or improve their process for validation of internal and subcontracted processes. I have also completed training in process validation for employees in quality, production and R&D.
In order to have a risk-based approach to process validation, I have helped companies with risk management of their and their subcontractors' processes based on FMEA (Failure Mode & Effect Analysis).
I also helped them to define the requirements for URS (User Requirements Specification) and to set-up a procedure for software validation.
21 CFR part 820: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.75
GHTS – Process Validation Guidance: http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf
Medical Device Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505