Services

cGMP Compliance Audit, PAI & Training


  • Pharmaceuticals
  • Cannabis
  • Biotechnology
  • Fine Chemicals & API
  • Healthcare & Hospitals
  • Foods

  • 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.

Are you looking for a Partner in Process Engineering, Clean Utilities, Project Management, CIP, Layout, Compliance, Validation, QA, Audit, PAI, Calibration or Energy Efficiency?


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Our Offices

CANADA

For commercial information, partnership and marketing requests with PBE Expert Inc, please contact :
+1 (514) 616-2692

+ 1 (450) 600-0790 x 253

pbe@pbe-expert.com

pbe@pharmabioeng.com3210, Francis Hughes Street, Laval, QC H7L 5A7

Our International Offices in :

Morocco


+(212) 661142327+ 212 522343291www.kimia.maa.elbahraoui@kimia.co.maRésidence EL HADIKA, 4E étage N°88 Ain Sebaa,Casablanca

Algeria


+213 (0) 5-40-96-12-34+ 213 (0) 31-76-61-83tm.ferlab@gmail.comcontact.ferlab@gmail.com147 bloc C, Ben Zakri, les Terrases, Constantine Algeria

Tunisia


+(216) 96-751-330

pbe@pbe-expert.com

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