Oral solid dose formulation & manufacturing considerations for high potency compounds
Liquid fill hard capsule (LFHC) and soft gel formulations offer optimal safety in formulation, scale-up and manufacturing of challenging compounds. This presentation will address scientific and practical aspects of process design relative to pharmaceutical development, scale-up and commercial production of LFHC-based formulations.
Specific topics that will be discussed include:
- Formulation and application considerations using lipid, liquid and semi-solid technologies
- Key considerations and steps required for safe and effective drug formulation using LFHC and soft gels
- Safe handling protocols and infrastructure considerations in commercial scale manufacturing
Alyn McNaughtonDirector of Analytical and Developemtn Sciences, Encap Drug DeliveryCapsugelUK
process & performance improvement
Integrating Lean and Six Sigma into all aspects of daily activities to improve efficiency by altering description emphasis
- Transforming a programme to a culture by amending wording to reflect the day-in, day-out efficient routine
- Re-branding improvement programmes as need-based systems where a lacking is identified and tools deployed in the most efficient manner
- Developing a work-force that are capable of acting proficiently, using Lean and Six Sigma, but are unaware of this complete integration
Deirdre CooneyDirector Operational ExcellenceAmgenIreland
Visualisation and driving Operational Efficiencies
- The challenges associated with standardisation in a multi-national corporation are large, but there are strong business and technical drivers for a standardised IT and Automation Systems Portfolio.
- Having a common technical platform is a key enabler for effective, efficient and compliant data integration and reporting.
- The role of Governance is critical in ensuring that source solutions are maintained and that the right information is presented to the right people at the right time.
Richard WilliamsLead, Manufacturing ITEli LillyUK
Global quality workflow: How automating a risk-based quality management system can streamline the complex quality lifecycle
• The challenges of a complex product lifecycle
• How organisations can overcome manual processes, and implement an automated global quality workflow
• How risk management improves the level and efficiency of compliance
• The various risk management tools available to streamline compliance in the automated QMS
• How one company began their journey to operational excellence with a global quality workflow
Alexandre Alain Life Science Product Manager EtQ, Inc.
Operational excellence + simulations: Bringing predictive analysis to biotech
- Using Operational Excellence as a starting point for simulations
- Using real data from your plant historians to build predictive simulations
- How simulations can help increase throughput by 30% or more with little or no capital investment?
- Case studies with, and without, a simulation model to show the benefit to manufacturers
Rick JohnstonFounder and PrincipalBio-G
Future proofing pharma operations in the world of adverse change
- Overcoming the many barriers to effective operations.
- Understanding cost drivers in a world where we measure conversion cost, but do not know how to change it.
- Optimising Cost of Operations while enhancing flexibility by using differentiated planning architectures.
- Thinking end To end and rightsizing and positioning Inventory, so that it adds value to the business.
- Thinking outside of the box of legacy thinking and lean posturing.
Dr John HarhenDirector Orbsen ConsultingIreland
process & performance improvement
Is lean thinking the antidote for lazy thinking?
- Six business case studies of how lean transformation exposed and transformed lazy thinking to lean thinking
- Design for success: create artificially what you hoped would occur naturally
- Reduce defects: when increase speed caused increase quality
- Customer centric: why all the questions, all the time
- Lazy layout: we never knew the rules but we obeyed
- Crazy planning: how can they work like that?
- Lean Journey: it’s more than a mapping exercise.
Dermot O'RourkeSite Operational Excellence LeadIpsenIreland
Guaranteeing validation robustness throughout the manufacturing process through a repeatable system to ensure compliancy requirements
- Measuring and evaluating process stability and process capability in order to meet regulatory requirements and guarantee quality
- Meeting the GAMP guidelines for computer validation and 21 CFR Part 11 for electronic records to ensure integrity and reliability of records
- Building validation as part of the complete life cycle of a computer system in order to satisfy Annex 11 of the European GMP directive
Thurloch O'CriodainGlobal Lead Quality StewardNovartisSwitzerland
Process & performance improvement
- Transforming OPEX into a company mind-set
- Creating sustainable improvement
- Establishing the next level of OPEX
- Implementing the most effective quality KPIs
- Increasing efficiency whilst maintaining quality
- Reducing complexity of operations while managing risk
Engineering facilities and technology
- Further reducing contamination in clean rooms
- Certifying quality and reliability during equipment procurement
- Safe and efficient API production
Supply chain integration
- Reducing time to market
- Adhering to varied serialisation legislation
- Guaranteeing global track and trace compliance