Sofia van Berlekom, AstraZeneca, Sweden
Tor Gråberg, AstraZeneca, Sweden
Dr Brigitte Gübitz, VTU Engineering, Austria
Aidan Madden, FivePharma, Ireland
Dr Lisa Matzen, Boehringer Ingelheim, Germany
Prof Jose C. Menezes, 4Tune Engineering, Portugal
Rui Pinto, Hovione, Portugal
Emma Ramnarine, Genentech/ Roche, USA
Dr Karmin Saadat, AGES, Austria and PIC/S QRM Expert Circle
Dr Franz Schönfeld, GMP Inspector, Germany
Dr Remo Studer, Galexis, Switzerland
- Discuss how to implement integrated quality risk-management principles over the life cycle of your products.
- Learn how to implement optimised Quality Risk Management (QRM) approaches to increase efficiencies and to meet the expectations of the regulators.
- Take advantage to meet, listen to and interact with colleagues, regulators and industry experts
The ultimate responsibility for the performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the marketing authorization holder (MAH). To achieve the quality objective, “there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice, Quality Control and Quality Risk Management.” [EU-GMP Guidelines, Part 1, Chapter 1].
Quality Risk Management (QRM) was formally introduced to the pharmaceutical industry in 2005 with the publication of ICH Q9 Guideline. But QRM is not only limited to the manufacturing process. It starts much earlier in the development phase and lasts until the distribution. Even more, the new ICH Q12 Draft Guideline (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) likes to facilitate risk-based regulatory oversight, e.g. for Post-Approval Change Management (PACM).
No matter in which area, the intent of QRM is to make data-driven and scientifically sound decisions and to support the agreed actions. Companies are currently establishing integrated risk-based thinking into their quality and regulatory affairs systems over the lifecycle of their products. This is more than just a task of the Quality Unit; it is bringing together knowledgeable people from different disciplines with various informed perspectives. The background and examples will be discussed in this QRM Summit.
This conference is designed for all persons in pharmaceutical, biopharmaceutical and API industry who establish, manage and improve quality risk management systems.
Part 1: QRM in the Lifecycle Management
Changing the Habits: Value and Role of Quality Risk Management
Life-Cycle Risk-Management in Quality by Design (QbD)
- Regulatory requirements on risk management over the whole product lifecycle
- The Importance of QRM
- How ICH Q8-Q12 Guidelines work together from
- Development to Product Realisation and Continuous Improvements
- Status Quo of risk management in the pharmaceuticals industry
- How to implement a lifecycle risk management
- Model of Object Oriented Risk Management
- Risk communication – a key enabler for efficient risk management
- Advantages by working with innovative risk management tools
Part 2: QRM in ICH Q12
Post approval CMC Lifecycle Management – Mitigation of global complexity?
Risk-based Post-Approval Development and Change Management
- Agile Post-Approval Change Management within ICH Q12
- PACM Protocols & Classification of Changes
- Regulatory Flexibility & Robustness of Current
- Pharmaceutical Quality Systems
Views and Expectations of the Regulators
- How to use QRM to assess criticality (minor/ major) of specific post-approval changes
- PACM protocols (access to data & info making established-conditions)
- How QRM can support post approval changes
- Risk-based regulatory oversight and optimisation of resources for assessment and inspection
- What type of changes will benefit
- Concerns and implications
Part 3: QRM meets Industry 4.0
Knowledge Management – a central Element of Industry 4.0 in Pharma Manufacture
QRM for agile Post-Approval Change Management
- The knowledge cycle at a Pharmaceutical CMDO
- Knowledge Management and Industry 4.0 – How to make the best use of digitalized data?
- Case studies
- Challenges and next steps
- Agility in PACM is a requirement of Industry 4.0
- QRM used over lifecycle enables risk-based decisions and knowledge-excellence
- Risk-management best practices for PACM
- Case Studies
Part 4: QRM in GMP/GDP
Is QRM (really) a new GMP Requirement?
How to effectively use QRM in the GMP Environment
- The Inspector’s View: Expectations
QRM and the new Annex 1
- QRM –more than risk assessment
- Defining what the risk is - vital for correct and effective QRM
- How to integrate QRM in the other PQS elements
- Effort and formality – adapt QRM to your everyday business as well as major project
The term “risk management” can be found 4 times and “risk assessment” 25 times in the new Annex 1. Discuss how to establish an integrated risk assessment process within sterile manufacturing processes.
GDP: Practical Approaches to QRM using FMEA
- Examples from: Inventory, High-level risk assessment (HLRA), FMEA
- Protocols and documentation