2011 Topics Included:

Playing it safe—Risk and people management in aseptic manufacturing

• Identifying the critical risks in the manufacturing process and how to manage them
• Ensuring GMP even without a hierarchical structure
• Choosing and developing the right people in aseptic manufacturing

Negotiating the regulatory minefield

• In what direction are the regulatory bodies going?
• Predicting future regulatory expectations
• What will the regulatory compliant lab of the future look like?

Sterilising through filtration

• Creating an effective filter sterilisation technique
• Correctly implementing a suitable validation test

Pre-filled injectables

• What are the advantages moving from vial to pre-filled?
• Overcoming the challenges faced
• When is the right time to move?

Current and future lyophilisation challenges and trends

• How versatile is modern lyophilisation?
• Overcoming the real world failures in the lyophilisation process
• Future and emerging techniques for lyophilisation

Supplier assurance

• What makes a supplier appropriate or inappropriate?
• Strategies to ensure suppliers are thoroughly checked and audited

Advanced barrier systems

• What are the challenges of retro fitting RABS & Isolators?
• Ensuring swift deployment in a sterile environment
• Where is the next investment?

GMP—How sterility fails

• What are the common failing points?
• What is the correct procedure once sterility is compromised?
• Creating a comprehensive Standard Operational Procedure (SOP)

Rapid release testing

• Ensuring regulatory compliance for batch release
• Avoiding the common pitfalls blocking rapid release
• What does the future hold for real time release testing?

Moving to a disposable manufacturing operation

• Identifying the potential benefits to single use technology?
• What are the current limitations to this technology?
• Overcoming the barriers to create a disposable lab

Cleanroom sterilisation

• Identifying the detrimental effects from cleaning agents and regimes?
• Combating the dangers to a cleanroom environment
• Gaining regulatory approval in a comprehensive yet sustainable way?

Minimising the batch record burden

• What are the latest regulatory requirements for batch records and batch record review?
• Minimising required documentation
• What is the future for batch manufacturing record and review?

Novel and emerging sterilisation technologies

• Identifying and implementing a thorough sterility testing method
• Analysing future technologies
• When is the best time to invest?

Blow-Fill-Seal technology

• What are the latest regulatory requirements?
• What are the current advantages over traditional aseptic processing?
• Overcoming the associated risks

Monitoring microbial environments

• Constructing a comprehensive monitoring programme
• What, when and how often?
• What is the correct response to contamination?

Lean manufacturing in a sterile environment

• Identifying the unique challenges of Lean manufacturing in a sterile environement
• Realising the ROI when implementing a Lean manufacturing strategy

 

 

 

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