Biotech Products and the Challenge of Next Generation Cleaning Strategies
Biotech Products and the Challenge of Next Generation Cleaning Strategies by: Marco Paolillo, GMP Compliance Advisor, Auditor & Associate Partner EMA (2014)[1] […]
Category: Pharma
What’s the “Cleaning Meaning”? The “5 Ws” of Cleaning Validation
What’s the “Cleaning Meaning”? The “5 Ws” of Cleaning Validation by: Marco Paolillo, GMP Compliance Advisor, Auditor & Associate Partner In Pharmaceutical […]
Regulatory Trends in Computer Systems Validation and Data Integrity: The Evolution of Gap Assessments, Remote Audits, Inspection Readiness and Remediation during the Covid 19 Pandemic
Regulatory Trends in Computer Systems Validation and Data Integrity: The Evolution of Gap Assessments, Remote Audits, Inspection Readiness and Remediation during the […]
The new EU GMP Annex 1 – Environmental Monitoring Sampling Zones.
The new EU GMP Annex 1 – Environmental Monitoring Sampling Zones by: Ana Franco Matamala – CQV Operations Manager @ PQE Group
How to deploy a LIMS
How to deploy a LIMS by: Raffaele Patruno – CSV/CSA & Data Integrity SME, Laboratory Manager & Associate Partner @ PQE Group
Cloud Computing in a Regulated Environment
Cloud Computing in a Regulated Environment by Simone Ristori IT Infrastructure Qualification, CSV/CSA Advisor Engineer & Local Equity Partner @PQE Group During […]
100 Generic Medicines Suspended due to Clinical Data Integrity: How to secure your business and ensure your clinical data is valid
100 Generic Medicines Suspended due to Clinical Data Integrity: How to secure your business and ensure your clinical data is valid by: […]
POINT OF CARE MANUFACTURE (POC): a new emerging model for innovative products
POINT OF CARE MANUFACTURE (POC): a new emerging model for innovative products by: Stefania Cislaghi – GMP Compliance Advisor & Auditor – […]
How the Regulatory Affairs Landscape can change in the post Covid-19 Era: the road so far and the emerging trends
How the Regulatory Affairs Landscape can change in the post Covid-19 Era: the road so far and the emerging trends by: Francesco […]
ASTM E2500 APPROACH, Process Equipment Suppliers and Qualification SMEs
ASTM E2500 APPROACH, Process Equipment Suppliers and Qualification SMEs by Zoltan Langosco Di Langosco Global Senior Sales Manager & Technology Provider @PQE […]