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Welcome & Learning Objectives
Setting the learning climate, participant introductions, and aligning expectations for a senior management audience
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GMP & GDP Laws & Regulations
EU regulatory framework, GDP guidelines, authorisation types, and the legal obligations that flow from each
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GMP/GDP as the Ultimate Business Case
Financial, reputational, and patient safety consequences of non-compliance; what is truly at stake for the organisation
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Which Authorisation for What?
MIA, WDA, Marketing Authorisation — what each covers, who holds it, and what compliance conditions are attached
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Responsibilities of the MAH Holder
MAH obligations across the product lifecycle: quality oversight, outsourcing, PQR, complaints, recalls, and continuous improvement
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Workshop: Do's & Don'ts in Market Actions
Interactive case exercise: distinguishing business decisions from GMP/GDP decisions and recognising where quality sign-off is required
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Quality & the Pharmaceutical Quality System
What quality means in pharma, what a PQS covers, and why it is both a legal requirement and a business enabler
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Essential Elements: Change Control, Deviations, CAPAs & Risk Management
How each element functions, what management-level oversight looks like, and how they interconnect to drive improvement
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Data Integrity
ALCOA+ principles, management's role in creating a culture of reliable data, and key regulatory expectations
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Vendor Management
Supplier qualification, quality agreements, audit oversight, and management's responsibility across the supply chain
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Behavioural Expectations & Human Error
How quality culture manifests in daily behaviour, the DCOM framework, habit loops, and the shift from blame to systemic thinking
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Quality Culture — Leadership's Role
Quality culture maturity models, Heinrich's Law applied to quality incidents, building blocks for culture improvement, and management's direct influence
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Quality Management Review
What the PQS requires from management review, how to read and challenge QMS dashboards, and what a high-quality review looks like
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The Role of the QP and RP
Legal status, responsibilities, required independence, and the relationship between senior management and the QP/RP
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Good Distribution Practices
GDP requirements relevant to management: receipt, storage, quarantine, customer qualification, transport, and outsourcing oversight
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Workshop: GDP in Practice
Case exercise on a complaint about damaged goods — what questions to ask, which systems to review, and how to lead the quality response
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How to Continue — Action Planning
Reflection on personal and organisational takeaways; each participant defines their top 3 priority actions
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Closure & Discussion
Final discussion, reinforcement of key messages, and certificate of attendance
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