cGMP Compliance Audit, PAI & Training

Sites c-GMP compliance certification, chemical containment license.
cGMP compliance Audit and pre-approval inspection (PAI).
Development of PAI plan and procedure: before, during and after inspection.
Corrective and Preventive Actions: CAPA, RAPA, GAPA.
Plans for remediation.
Management and Implementation of a change control system.
Continuous Improvement & Quality Audit of supplier’s qualification.
Drafting and revision of suppliers Quality Assurance Agreements (QAA).
Development of the Site Master File (SMF).
cGMP Training: PBE Expert Inc is a CPMT training company with agreement #0059104 & EPIC/OIQ recognition.

Sites c-GMP compliance certification, chemical containment license, QPIC.
cGMP compliance Audit and pre-approval inspection (PAI).
Development of PAI plan and procedure: before, during and after inspection.
Corrective and Preventive Actions: CAPA, RAPA, GAPA.
Plans for remediation.
Management and Implementation of a change control system.
Continuous Improvement & Quality Audit of supplier’s qualification.
Drafting and revision of suppliers Quality Assurance Agreements (QAA).
Development of the Site Master File (SMF).
cGMP Training: PBE Expert Inc is a CPMT training company with agreement #0059104 & EPIC/OIQ recognition.

Sites c-GMP compliance certification, chemical containment license.
cGMP compliance Audit and pre-approval inspection (PAI).
Development of PAI plan and procedure: before, during and after inspection.
Corrective and Preventive Actions: CAPA, RAPA, GAPA.
Plans for remediation.
Management and Implementation of a change control system.
Continuous Improvement & Quality Audit of supplier’s qualification.
Drafting and revision of suppliers Quality Assurance Agreements (QAA).
Development of the Site Master File (SMF).
cGMP Training: PBE Expert Inc is a CPMT training company with agreement #0059104 & EPIC/OIQ recognition.

Sites c-GMP compliance certification, chemical containment license.
cGMP compliance Audit and pre-approval inspection (PAI).
Development of PAI plan and procedure: before, during and after inspection.
Corrective and Preventive Actions: CAPA, RAPA, GAPA.
Plans for remediation(6).
Management and Implementation of a change control system.
Continuous Improvement & Quality Audit of supplier’s qualification.
Drafting and revision of suppliers Quality Assurance Agreements (QAA).
Development of the Site Master File (SMF).
cGMP Training: PBE Expert Inc is a CPMT training company with agreement #0059104 & EPIC/OIQ recognition.

Sites c-GMP compliance certification, chemical containment license.
cGMP compliance Audit and pre-approval inspection (PAI).
Development of PAI plan and procedure: before, during and after inspection.
Corrective and Preventive Actions: CAPA, RAPA, GAPA.
Plans for remediation.
Management and Implementation of a change control system.
Continuous Improvement & Quality Audit of supplier’s qualification.
Drafting and revision of suppliers Quality Assurance Agreements (QAA).
Development of the Site Master File (SMF).
cGMP Training: PBE Expert Inc is a CPMT training company with agreement #0059104 & EPIC/OIQ recognition.

Sites HACCP, ISO-22000, SQF, GFSI compliance certification. PBE Expert is a MAPAQ qualified Consultant to “ La mesure 2 du programme Levier ”.
HACCP, ISO-22000, SQF, GFSI compliance audit and pre-approval inspection (PAI).
Development of PAI plan and procedure: before, during and after inspection.
Corrective and Preventive Measures: CPM, RAPA, GAPA.
Plans for remediation.
Management and Implementation of a change control system.
Continuous Improvement & Quality Audit of supplier’s qualification.
Development of the Site Master File (SMF).
cGMP Training: PBE Expert Inc is a CPMT training company with agreement #0059104 & EPIC/OIQ recognition.
Qualification DQ, IQ, OQ: equipment & classified cleanrooms, quality control Labs equipment, freezer & cold rooms, autoclave, freeze-dryer, isolator, oven, stability room, CIP, SIP, HVAC, PW, EPPI, pure steam, compressed air, N2.
Sampling Plan, and MACO.
Process Validation, of cleaning and sterilization (FDA 2011, EMA 2015).
Sterilization cycles development, Media-Fill tests.
Computer validation, CSV: BMS, PLC, qualification of ERP software, SAP (GAMP, CFR21-11), data integrity.