GROUP

V 1.0

TRAININGS CATALOGUE

Areas

Data Integrity & Computer System

Validation

Good Clinical Practice

Pharmacovigilance

GROUP

ComplianceDigital Governance Qualification & Engineering

Warning Letters Triggered by Data Integrity Failures and 483s “Why do we care”Data Integrity Regulatory Trends and Applicable Requirements “What is required”Computer System Validation PrinciplesData Integrity Compliance AssessmentRegulated Metadata and DataComputer Validation Life Cycle: Prospective ValidationGAPs Solutions Portfolio “Quick Wins for Technical GAPs”How to Approach New Computer System “Avoid to Generate New GAPs”How to Maintain the Compliance Status “Avoid Rework and Waste of Efforts”Remediation Activities - Case Studies & Tools “How to Remediate and Validate”Data Integrity ALCOA+ PrinciplesAudit Trail ReviewPLC- Based Systems Validation ApproachData Integrity Program Organization - Governance and Maintenance ActivitiesGood and Bad Validation PracticeSerialization Principles

Data Integrity & Computer System Validation

Global leader in full product life cycle Computer System Validation, Data Integrity and IT Compliance.

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Training Pharma Capabilities

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Medical Devices Capabilities

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GROUP

DigitalGovernanceThe 4th Industrial Revolution brings new technologies with itself.

Training

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Pharma Capabilities

Medical Devices Capabilities

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Drivers for IT Infrastructure Conceptual DesignIT Infrastructure Qualification MaintenanceDelivering IT Services to a Regulated CompanyGood Documentation PracticeBasics of ISO-9001-2015 Analysis of ISO-9001-2015 Blockchain and DLT: Principles and Applications in the Regulated IndustryBasics of AI and Predictive AnalyticsIIoT - Industrial Internet of thingsOverview of ITIL 4.0Fundamentals of Cybersecurity Cybersecurity Employee Awareness

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GDPR Basic ConceptsGDPR Daily RulesCompany AccountabilityKey RolesGDPR Subject RightsData Privacy by Design & by DefaultIT Infrastructure Qualification Strategy & Life CycleNew Technologies RequirementsIT Infrastructure Control and Compliance - GPG Second EditionCloud Service & Data IntegrityRegulatory Drivers for IT Infrastructure QualificationPrinciples of Organization of an IT Department Operating in a Regulated Environment

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Qualification & EngineeringOur service excellence is achieved through an interdisciplinary teamwork among engineers and technicians, who have a unique integrated knowledge in process engineering, information technology and quality in regulated environments.

TrainingGeneral Concepts of Equipment Qualification & Instruments CalibrationQualification of Solid Dosage Forms ProcessesQualification of Sterile Dosage Forms ProcessesQualification of Biotech ProcessesHVAC & Clean Areas: Design, Regulatory Expectations and Qualification PracticesPharmaceutical Water Production, Storage and Distribution: Design, Regulatory Expectations and Qualification PracticesCompressed Air Generation, Storage and Distribution: Design, Regulatory Expectations and Qualification PracticesNitrogen Storage and Distribution: Design, Regulatory Expectations & Qualification Practices Autoclave QualificationMoist Heat Sterilization Ethylene Oxide SterilizationProcess Control Systems ValidationVisual Inspection MachineFreeze Dryer QualificationVHP SterilizationPeriodical RequalificationValidation Master PlanHVAC Practical On-Site Testing Thermal Validation Practical On-Site Testing Transport, Warehouse and Controlled Temperature Units ValidationFilling Lines Qualification

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Pharma Capabilities

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Pharmaceutical Water Production, Storage and Distribution: Design, Regulatory Expectations and Qualification PracticesCompressed Air Generation, Storage and Distribution: Design, Regulatory Expectations and Qualification PracticesNitrogen Storage and Distribution: Design, Regulatory Expectations & Qualification Practices Process Control Systems ValidationMedical Devices Pathway for Compliance: Processes Development & Validation Medical Devices Process Validation: Case StudiesManagement Responsibility & Handling of FDA InspectionsEtO Sterilization Validation Master PlanHVAC Practical On-Site Testing

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Medical Devices Capabilities

GROUP

6

Deviation Management and Investigation TechniquesCleaning ValidationData Integrity and ALCOA+ Sterility Assurance and Annex 1Audit Management Good Manufacturing Practice Good Documentation PracticeICH Q7 - Good Manufacturing Practice Guide for APIGMP for Medicinal ProductGood Distribution PracticeChange Control ManagementCross-Contamination Housekeeping and Pest ControlICH Q9 - Quality Risk Management GDP - Quality Risk Management IPEC - Guidelines for ExcipientsInvestigational Medicinal ProductsOOT, OOS and OOE ManagementGMP for QC Laboratory: Roles and Responsibilities 5s ModelHuman Blood - Plasma production (Annex 14)Microbiological QC Lab ManagementVisual ManagementEU vs China GMP (FPF)PQR and AQR (Product-Annual Quality Review) Good Laboratory Practice

ComplianceWe offer practical training courses based on latest pharma industry guidances, medical device regulations, real life experiences & all GxP related challenges your business may face.

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Training Pharma CapabilitiesDeviation ManagementReagents and Standards ManagementAnalysis and Sample ManagementAnalysis Execution and CertificationAnalytical Methods Validation and TransferComplaints and RecallGxP Compliance - General Training ConceptsSelf-InspectionRoles and Responsibilities in ManufacturingMaterials FlowManufacturing and Batch ApprovalProcess ValidationProcess TransferSampling and DispensingStorage and ShippingQuality Culture and Quality Metrics (Continuous Improvement)Analytical Procedures Lifecycle ApproachSupplier ManagementMicrobiological Environmental MonitoringHow to Manage an FDA InspectionCAPA ManagementTraining ManagementFacilities & Equipment/Utilities: Design, Qualification and Maintenance/CalibrationPackaging & Labelling - GMP Requirements and Best PracticesStability Management

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GROUP

Audit Management Good Distribution PracticeCross-Contamination Microbiological QC Lab ManagementComplaints and RecallRoles and Responsibilities in ManufacturingMaterials FlowProcess TransferStorage and ShippingQuality Culture and Quality Metrics (Continuous Improvement)Supplier ManagementTraining ManagementISO 13485:2016 - Medical DevicesQuality Management Systems Requirements for Regulatory PurposesISO 13485:2016 vs ISO 13485:2003Important Changes

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Medical Devices Capabilities21 CFR Part 820How to Manage an FDA Inspection21 CFR PART 803 - 806Medical Device ReportingReports of Corrections and RemovalsMDSAP - Medical Device Single Audit Program for the Manufacturers of Medical DevicesDesign Control & Design ChangesEN ISO 14971:2012 Medical Devices Application of Risk Management to Medical Devices Medical Device Directive (MDD) 93/42 EECNew MDR “New European Regulations for Medical Devices”ISO CEI/IEC 62304:2006Medical Device Software - Software Life Cycle ProcessesUsability Process Validation for MDMD Compliance - General Training Concepts

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PharmacovigilanceIn 2010, Regulatory Authorities raised the bar of compliance of the Pharmacovigilance System and an increasing number of countries are now performing routine regulatory inspections targeting Pharmacovigilance.

Training

European PV processes (case processing, risk management plan, periodic aggregate report, signal detection, risk managament system)PV requirements across the WorldEU Pharmacovigilance System Mater File (PSMF)GVP Module I on Quality Management System in PharmacovigilanceQuality across EU GVP modulesAudit Management: GVP Module IV and ISO 19011:2018Medication Error ManagementGDPR in PharmacovigilancePost-authorisation safety study: PASS and PAESElectronic Archiving and Paperless System ManagementArchiving Requirements in Pharmacovigilance and Outsourcing models

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Pharma Capabilities

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GROUP

Deviation Management in Clinical Studies Randomization in Clinical TrialsValidation of IRT SystemsGCP Principles & Addendum OverviewRegulatory Framework for Study Conduction (European, Italian and FDA Regulations)IMP Management in Clinical TrialsSafety Management in Clinical TrialsManagement of the Clinical Trial Master FileData Integrity Requirements for Clinical Trial ManagementClinical IT Supplier Management: Criticalities and Main AspectsRisk Management in Clinical Trial

Good Clinical Practice

The development of a GCP Quality Management System (plan and resources) is the basis to promote and support compliance, while minimizing regulatory risk.PQE proposes the implementation of a GCP quality strategy, tailored to the Client’s requirements, and supports an effective and compliant conduction of clinical trials, based on the practice of the most innovative Quality by Design and Quality Risk Management approaches.

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Training

Pharma Capabilities

10

GROUP

Delivery Model

GROUP

Tailor madeWebinar

•LIVE

E-Learning

Available in:

Classroom F2F Coaching

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GROUP

Choose PQE Group, we support you globally thinking locally.

HEADQUARTERSLocalità Prulli, 103/C • 50066 Reggello (Florence) ITALYT +39.055.5275100 • F +39 055.5275142

GROUP

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