Welcome to the ISPE Proposal Submission Site
ISPE is currently accepting proposals for the following conferences:
- 2020 ISPE Europe Annual Conference - 30 March - 01 April 2020, Madrid, Spain
Call for Proposals Now Open
Deadline: 15 September 2019
- Facilities of the Future - The 2020 ISPE Europe Annual Conference ‘Facilities of the Future’ track is about pharmaceutical facilities in a transition. The last couple of years have brought to market a number of breakthrough products that have shown significant promise for patients and health care, but the pharmaceutical companies are still challenged to implement the new technologies in real manufacturing. Cost-effective solutions, continuous manufacturing, cell and gene therapy and pharma robotics are some of the hot issues of tomorrow.
The track will include both new and innovative technologies and a number of impressive case studies from recent facilities, including the winners of the ISPE 2020 Facility of the Year Award (FOYA).
It is a must-attend for everyone involved in planning, investing or supplying technology into the pharmaceutical industry of today and tomorrow.
The Facilities of the Future track includes three main sessions:
- Continuous Manufacturing for Bio-products and Oral Solid Dosage forms
- Advanced Therapy Medicinal Product (ATMP) and the future of Aseptic Processing
- Technical Innovation
- Pharma 4.0 – What is the way to implement the new operating model with industry cases, application of maturity models, digitisation, self-learning devices, plug and produce and a holistic control strategy. Pharma 4.0 is the dominant theme in the Digitalisation of the pharmaceutical industry with the advent of ISPE Pharma 4.0 Operating Model and the Smart Manufacturing approach results in disruptive changes managed by the ISPE Pharma 4.0 Operating Model. Extending the current ICH Q10 Pharmaceutical Quality Systems / PQS with digital enablers Digital Maturity and Data Integrity by Design need new design concepts. The physical and operational design of the pharmaceutical equipment, facilities, logistics and operations concept incl. e.g. work instructions shall be based on Process Maps and Process Data Maps. This needs the early collaboration of all pharmaceutical departments: QA, QC, Process Development, Manufacturing Operations, Engineering, Automation and IT to design a facility which is operating with a high-quality level, robust, flexible and right first time. This needs also a "Data Integrity by Design" implementation principle to enable Data Integrity by applying a risk-based approach based on "Critical Thinking". Future facilities will have a high level of automation. Current Regulatory Guidelines are in place to leverage these potentials but examples to put them into practice are still missing. There is also an increasing strong demand by Regulatory Authorities and Inspectors to apply the current requirements of Risk Management, efficient and safe production for pharmaceutical products. The ISPE Pharma 4.0 Operating Model has the Holistic Control Strategy as a core element. A well-designed Holistic Control Strategy is enabling Right First Time, Data Integrity by Design and high-performance best practice-based processes. The Digitalisation of the ICH Q10 Pharmaceutical Quality System and the change process from paper to paperless processes is key for achieving Digital Maturity. The Digitalisation of well-defined Business Processes and Pharmaceutical Processes is the profound basis for applying Data Integrity by Design.
- Quality, Process Validation, QRM How to adapt current quality systems to new products, processes and regulations? This quality and compliance track will address the challenges pharmaceutical industry is currently facing with regards to new products (personalised medicines, medical device IT applications, biotech,..), new processes (continuous manufacturing, real time release,…) and new regulations (Annex II, New regulatory guidances and Harmonisation of regulatory bodies). The track goal is to get to know what is already happening in the industry and share best practices in this domain. Submissions that make significant contributions to understand through a practical perspective industry developments, strategies or practical implementation case studies are especially welcome. The track papers are expected to contribute to the current body of knowledge for pharmaceutical manufacturing, quality management, and technology.
- Operational Excellence: New trends in CQV and Impact on Project Delivery New approaches to Commissioning, Qualification, Validation (CQV) and GAMP with focus on a compliance, efficiency and cost effectiveness have a huge impact on the organisation and workflows of capital projects.
The discussion among engineers, production staff and Quality members under the pressure to deliver the “magical triangle” Quality, Time and Cost is a constant challenge to define what systems need to be commissioned and what is essential to be qualified and validated.
Industry has progressively moved to a science and risk-based approach with emphasis on Quality by Design, and risks to product quality. Hence Qualification is now focusing on Critical Design Elements (CDE’s) and Critical Process Parameters (CPP’s) which are key to product Critical Quality Attributes (CQA’s).
Key areas in the new CQV approach are:
- URS Definition including “fitness for use” and differentiate requirements (what) from specs (how) and distinguish between quality impact and no quality impact
- Risk Assessment to identify Critical Design Elements (CDE’s)
- An optimised Design Review/Design Qualification process, focused on the CDEs
- A clear C&Q plan process, including a Document Approval Matrix
- Non-classical production methods such as continuous manufacturing or single unit batches
- Quality by design, incl. the drive for full PAT (process analytical technologies) coverage
- A streamlined structure in how to execute the testing, including engineering and quality differentiation and testing phase minimum requirements for completion
- The traceability matrix as a project management tool
- A streamlined, risk-based approach to periodic review
- Supplier verification and acceptance with minimal repetition
- Differentiates engineering change management from operational change control
- Contemporary/simple examples for all steps of the C&Q process
- By submitting a proposal, you acknowledge that, if your proposal is accepted, your organization will support your attendance at the conference.
- Accepted session leaders and speakers are responsible for their own travel and accommodations.
- Session leaders and speakers giving a full (25-minute or longer) presentation receive complimentary conference registration.
- Session leaders who are not giving a full presentation, co-leaders, co-presenters, poster presenters, and panel only participants are eligible for discounted rate on education registration.
All presentations must be free of commercial intent. Incomplete proposals will not be considered.
All speakers are expected to make their presentations (either full or abridged versions) available to conference attendees. ISPE secures all presentations prior to posting.
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Questions? Organizer: Marianne Bock -
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