PBE Expert Inc, we Process, Build, Engineer
Services
Quality assurance & Regulatory affairs
- Pharmaceuticals
- Cannabis
- Biotechnology
- Fine Chemicals & API
- Healthcare & Hospitals
- Foods
- Pulp & Paper
- Biorefinery & Biofuel
- Quality Assurance & batch release.
- QPIC services for controlled substances: THC cannabis, opiates, morphine.
- Drafting of procedures: SOP.
- Manufacturing operation support and health & safety services.
- Change Control, CAPA, FMEA: Failure Modes Effect Analysis.
- Root Causes Analysis “RCA“.
- Annual product review “APR”, Information technology & Data integrity: Capability.
- Risks management, analysis, and mitigation. Gap analysis and impact study RAPA/GAPA FMEA: ICH Q9, ATEX, FMD-135.
- Industry 4.0, IoT, collection and data integrity, ERP, SAP, LIMS.
- Cannabis producer’s licenses registration, DIN/NPN of THC & CBD.
- Regulatory Affairs, registration of drugs (DIN) and NHP (NPN).
- Registration of the licenses of establishment licenses (DEL) and Medical Devices (MDEL).
- Quality Assurance(22) & batch release.
- QPIC services for controlled substances: THC cannabis, opiates, morphine.
- Drafting of procedures: SOP.
- Manufacturing operation support and health & safety services.
- Change Control, CAPA, Failure Modes Effect Analysis : FMEA.
- Root Causes Analysis “RCA“.
- Annual product review “APR”, Information technology & Data integrity: Capability.
- Risks management, analysis, and mitigation. Gap analysis and impact study RAPA/GAPA FMEA: ICH Q9, ATEX, FMD-135.
- Industry 4.0, IoT, collection and data integrity, CSV, ERP, SAP, LIMS.
- Cannabis producer’s licenses registration, DIN/NPN(6) of THC & CBD.
- Regulatory Affairs, registration of drugs (DIN) and NHP (NPN) and related Vaults.
- Registration of the establishment licenses (DEL) and Medical Devices (MDEL).
- Quality Assurance & batch release.
- QPIC services for controlled substances: THC cannabis, opiates, morphine.
- Drafting of procedures: SOP.
- Manufacturing operation support and health & safety services.
- Change Control, CAPA, Failure Modes Effect Analysis : FMEA.
- Root Causes Analysis “RCA“.
- Annual product review “APR“, Information technology & Data integrity: Capability.
- Risks management, analysis, and mitigation. Gap analysis and impact study RAPA/GAPA FMEA: ICH Q9, ATEX, FMD-135.
- Industry 4.0, IoT, collection and data integrity, CSV, ERP, SAP, LIMS.
- Cannabis producer’s licenses registration, DIN/NPN of THC & CBD.
- Regulatory Affairs, (DIN) registration of drugs.
- Registration of the establishment licenses (DEL).
- Quality Assurance & batch release.
- QPIC services for controlled substances: THC cannabis, opiates, morphine.
- Drafting of procedures: SOP.
- Manufacturing operation support and health & safety services.
- Change Control, CAPA, Failure Modes Effect Analysis : FMEA.
- Root Causes Analysis “RCA“.
- Annual product review “APR”, Information technology & Data integrity: Capability.
- Risks management, analysis, and mitigation. Gap analysis and impact study RAPA/GAPA FMEA: ICH Q9, ATEX, FMD-135.
- Industry 4.0, IoT, collection and data integrity, CSV, ERP, SAP, LIMS.
- Regulatory Affairs, registration of drugs (DIN) and NHP (NPN).
- Registration of the establishment licenses (DEL) and Medical Devices (MDEL).
- Quality Assurance & batch release.
- QPIC services for controlled substances: THC cannabis, opiates, morphine.
- Drafting of procedures: SOP.
- Manufacturing operation support and health & safety services.
- Change Control, CAPA, Failure Modes Effect Analysis : FMEA.
- Root Causes Analysis “RCA“.
- Annual product review “APR”, Information technology & Data integrity: Capability.
- Risks management, analysis, and mitigation. Gap analysis and impact study RAPA/GAPA FMEA: ICH Q9, ATEX, FMD-135.
- Industry 4.0, IoT, collection and data integrity, CSV, ERP, SAP, LIMS.
- Cannabis producer’s licenses registration, DIN/NPN of THC & CBD.
- Regulatory Affairs, registration of drugs.
- Predictive maintenance, systemic, and preventive plan & program
- Metrology, calibration program, calibration of the instruments, and traceability.
- Mapping (temperature, humidity) cold room, warehouse, freezer, incubator, autoclave, freeze dryer, microwave (thawing of foods before processing).
- Commissioning (DQ, FAT, SAT).
- Quality Assurance & In Process Control.
- Drafting of procedures: SOP.
- Manufacturing operation support and health & safety services.
- Change Control, CAPA, Failure Modes Effect Analysis : FMEA.
- Root Causes Analysis “RCA“.
- Risks management, analysis, and mitigation. Gap analysis and impact study RAPA/GAPA FMEA: ICH Q9, ATEX(8).
- Industry 4.0, IoT, collection and data integrity, CSV, ERP, SAP, LIMS.
- Training: PBE Expert Inc is a CPMT training company with agreement #0059104 & EPIC/OIQ recognition.
- Predictive maintenance, systemic, and preventive plan & program.
- Metrology, calibration program, calibration of the instruments, and traceability.
- Mapping (temperature, humidity) of warehouse & microwaves.
- Commissioning (DQ, FAT, SAT).
- Quality Assurance & In Process Control.
- Drafting of procedures: SOP.
- Manufacturing operation support and health & safety services.
- Change Control, CAPA, Failure Modes Effect Analysis : FMEA.
- Root Causes Analysis “RCA“.
- Risks management, analysis, and mitigation: HAZOP.
- Industry 4.0, IoT, collection and data integrity, CSV, ERP, SAP, LIMS.
- Training: PBE Expert Inc is a CPMT training company with agreement #0059104 & EPIC/OIQ recognition.
- Predictive maintenance, systemic, and preventive plan & program.
- Metrology, calibration program, calibration of the instruments, and traceability.
- Mapping (temperature, humidity) of warehouse & microwaves.
- Commissioning (DQ, FAT, SAT).
- Quality Assurance & In Process Control.
- Drafting of procedures: SOP.
- Manufacturing operation support and health & safety services.
- Change Control, CAPA, Failure Modes Effect Analysis : FMEA.
- Root Causes Analysis “RCA“.
- Risks management, analysis, and mitigation: HAZOP.
- Industry 4.0, IoT, collection and data integrity, CSV, ERP, SAP, LIMS.
- Training: PBE Expert Inc is a CPMT training company with agreement #0059104 & EPIC/OIQ recognition.
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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CANADA
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