Quality Assurance

Every Quality Assurance course in the Zentrum24 Academy library. Read the first two pages of any of them free.

• Customer Complaint Management in Sterile ManufacturingReceiving and classifying a complaint, deciding whether it is reportable, investigating against batch records and retains, responding, and trending.
• Deviation Management and Investigation in Sterile ManufacturingRecording a deviation while the facts are fresh, containment, risk classification, root cause analysis, product impact, and CAPA that actually closes it.
• Governance and Protocols of the Material Review Board (MRB)How a material review board decides — membership and quorum, the evidence it needs, use-as-is, rework, reject and return, and documenting the rationale.
• Management of Animal Origin Materials (AOM) in cGMP ManufacturingControlling materials of animal origin — TSE/BSE risk assessment, country of origin documentation, certificates, and traceability through manufacture.
• Management of Nonconforming Materials (NCM) and Supplier ComplaintsSegregating and dispositioning nonconforming material, raising a supplier complaint with evidence, tracking the response, and trending recurring defects.
• Quality and Technical Agreements (QTA) in Sterile ManufacturingWho does what between site and client — testing and release responsibilities, change and deviation notification, audit rights, and periodic review.
• New Product Assessment and Risk Introduction ProtocolAssessing a new product before it enters the site — facility and cross-contamination risk, containment, analytical capability, and the go/no-go decision.
• Nitrosamine Impurity Risk Management (Protocol DP-MFG-FACILITY)Nitrosamine risk assessment across process and materials, confirmatory testing, acceptable intake limits, control strategy, and reporting obligations.
• Parenteral Packaging Quality Assurance and AQL Inspection ProtocolsAQL inspection of packaging components — containers, closures, labels and cartons: sampling plans and levels, defect classification, and a failed lot.
• Parenteral Quality Assurance and AQL Inspection ProceduresAQL inspection of filled parenteral units — critical, major and minor defect definitions, inspector qualification, sampling, and disposition of the lot.
• Periodic Product Quality Evaluation (PPQE)The annual product review in practice — batch and deviation data, trend analysis, specification and stability review, and the conclusions it must reach.
• Product Recall and Regulatory Notification ProtocolsDeciding recall class and depth, mock recalls, notifying agencies and customers, reconciling returned product, and closing with an effectiveness check.
• Protocol for Reworking and Reprocessing GMP MaterialsWhen rework or reprocessing is permitted, the protocol and approvals it needs, additional testing and stability, and the batch record trail it leaves.
• Quality Assurance Approval of Item Masters for cGMP OperationsGetting an item master right before it is used — specification links, unit of measure, shelf life and storage attributes, QA approval, and later changes.
• Quality Assurance Hold and Out-of-Service Equipment ProceduresPlacing equipment or material on hold — tagging and system status, who may release it, interim controls, and proving nothing moved while it was held.
• Quality Management Review (QMR) SystemsThe management review regulators expect — the metrics that go in, frequency and attendance, decisions and actions out, and evidence the system works.
• Quality System Change Control in Sterile ManufacturingRaising a change with a real impact assessment, classifying it, gathering approvals, implementation and verification, and closing with effectiveness review.
• Regulatory Change Control and Client Notification StandardsChanges that touch a filing — assessing regulatory impact, notifying clients and agencies, prior approval versus notification, and sequencing implementation.
• Supplier Change Notification (SCN) ManagementHandling a supplier's notice of change — impact assessment across products, requalification, downstream client notification, and managing the effective date.
• Suspect and Illegitimate Drug Product Identification ProtocolRecognising suspect or illegitimate product, quarantine and investigation, verification with trading partners, agency notification, and termination records.
• System Validation and Quality Maintenance PolicyKeeping validated systems validated — periodic review, requalification triggers, links to maintenance and calibration, change control, and the state record.