Quality Risk Management Summit
Im Auftrag der ECA Academy

Programm

Part 1: QRM in the Lifecycle Management

Changing the Habits: Value and Role of Quality Risk Management

• 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

Life-Cycle Risk-Management in Quality by Design (QbD)

• 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?

• Agile Post-Approval Change Management within ICH Q12
• PACM Protocols & Classification of Changes
• Regulatory Flexibility & Robustness of Current
• Pharmaceutical Quality Systems

Risk-based Post-Approval Development and Change Management

• How to use QRM to assess criticality (minor/ major) of specific post-approval changes
• PACM protocols (access to data & info making established-conditions)

Views and Expectations of the Regulators

• ICH Q12: a way to relief burden for regulators and industry to the benefit of patients by harmonising change classifications, requirements and review timelines?
• 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

• 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

QRM for agile Post-Approval Change Management

• 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?

• The Inspector’s View: Expectations
• Examples

How to effectively use QRM in the GMP Environment

• 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

QRM in a complex global pharmaceutical Organisation as enabler for Knowledge Management and Quality Oversight

• How to implement QRM oversight: harmonization as one of the key elements
• Management of risks; Risk register principles including escalation of risks in a global organization
• Example of implementation of an IT tool enabling a better overview, follow-up of overall risks and knowledge management
• Delimitation of responsibilities and interfaces over the product life cycle based on a common denominator

QRM and the new Annex 1
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