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SP6407- Risk Management in the Pharmaceutical Industry (3 days)

Quality Risk Management is now at the cutting edge of the Life Sciences industry internationally.   Earlier this year, the ICH Q9 Guideline on Quality Risk Management was incorporated as GMP Annex 20 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. SeerPharma presents this highly interactive, hands on practical 3 day course on how to apply risk management principles and tools.

The program is presented as six workshop based modules:

• General Principles of Risk Management and Compliance
  
• Risk Management Master Plans and Tools
  
• Applying Risk Management to Quality Assurance and Compliance
  
• Applying Risk Management to Product Design
  
• Applying Risk Analysis to Process Design (HACCP)
  
• Applying Risk Management to Validation

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
  
• Utilise 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

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.

Who should enrol?

• Quality Assurance
• Production Operations
• CGMP Compliance
• Validation
• Engineering
• Technical Services
• Product and Process Development
• Project management within the therapeutics industry

Fees: $1,550 (+ GST)
Fees include extensive notes and templates for risk-based tools.

A 5% discount applies for 2 or more participants from one company.