The Pharmaceutical Quality System (PQS), supported by ICH Q10, is the key foundation on which product realization depend. Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course. We will be using QMS and PQS terms interchangeably throughout this course to establish a holistic approach.
Apply ICH Q9 philosophy, principles and risk management to assess the impact:
Change Management, including
EU: Type IA, IB, II; Post Approval Change Management Protocols and US: CBE, Post
Approval Supplements, Annual Reportable, Comparability Protocols
Discuss the organization and use of external parties; how to get the best from similarities and differences between PQS systems in Contract givers and Contract receivers; monitoring suppliers (e.g. technical agreements, ‘ownership’ of supply chain, differing views of Stage 3 CPV scope).
Understand State of Control, what it means and how it relates to:
Validation and CPV/OPV, APQR
PV lifecycle Stage 3
Understand the importance of establishing a cross-functional quality culture for successful PQS implementation and to ensure product quality by applying the tools provided.
Who Should Attend
Tech transfer functions
Early career (3-5 years within the industry)
Qualified persons in Europe
Team Lead/Operator/Technician Staff
Supervisors and CEOs
Owner or General Manager working in pharmaceutical and biotech manufacturing (not CMO)
Architecture or construction
Service provider or consulting
Equipment or material supplier
This course is not currently scheduled, but may be offered at your company site.
Please contact ISPE for more information
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