Quality Risk Management is now at the cutting edge of the Life Sciences industry internationally. Recently, the ICH Q9 Guideline on Quality Risk Management was incorporated as GMP Annex 19 by the MHRA and the EMEA. GMP Annex 11 is currently under revision to include a clear reference to a risk-based approach for determining the level of validation.
Regulators expect that pharmaceutical professionals use risk management techniques and tools to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System. Regulatory Compliance Associates Inc. presents this highly interactive, hands-on course on how to apply risk management principles and tools.
Objectives
On completion of this subject, students will be able to:
- Articulate and evaluate the principles and practices of risk management in pharmaceutical operations
- Make judgments based on risk management principles
- Utilize risk evaluation techniques to analysis pharmaceutical products, operations and systems
- Propose control strategies and plans to mitigate unacceptable risk and loss to organizations
- Identify opportunities to reduce validation time and effort
Content
This subject covers the following topics:
- Principles of risk management (analysis, control and management)
- Regulatory guidance for applying risk management in pharmaceuticals - FDA, EU/PICs/TGA, ICH
- Presentation on ICH Q9 - Pharmaceutical Risk Management
- Risk analysis and risk control applications in design control - using the medical devices cascade model and ISO 14971
- Quality by Design - Risk analysis in design and development of products
- Application of risk analysis and risk to quality management systems and CAPA systems
- Application of risk assessment for managing product complaints
- Application of risk analysis in compliance and auditing of pharmaceutical operations
- Hazard Analysis and Critical Control Point (HACCP) in production and process control
- Application of risk principles in commissioning, qualification and process validation
- Development of a Risk Management Master Plan
Who should enroll?
The course is designed to service a wide range of participants from specific disciplines within the pharmaceutical industry. Participants wishing to enhance their professional development and advancement in Pharmaceutical management are particularly encouraged to apply. Typically participants will be managers or supervisors who have experiences in a GMP related environment.
This subject is specifically designed for participants who have prior knowledge in GMP compliance, Quality Assurance, Validation or Product Development practices or those considering working in the pharmaceutical or biotechnology sectors. You should enroll if you have an interest in:
- Quality Assurance
- Production Operations
- CGMP Compliance
- Validation
- Engineering
- Technical Services
- Product and Process Development
- Project management within the therapeutics industry
Format
The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided