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Factories of the Future: Back-up Manufacturing, Contingency Plans, More Local API Production?
Industry's and Regulators' View on COVID-19: Impact on Industry and Regulation
New Trends in CQV and Impact on Project Delivery in Times of Corona Crisis
Factories of the Future: Back up Manufacturing, Contingency Plans, More Local API Production?
Factories of the Future: Back-up Manufacturing;Contingency Plans;More Local API Production?
Contamination and Cross Contamination Control for Bio Safety
Facility Considerations for Next-Generation Sterile Product Manufacturing
Containment: Understanding Why, When, and What Regulatory Agencies Expect
PLENARY SESSION: The revision of EU GMPs Annex 1: What impacts can we expect as an industry?
INTERACTIVE REGULATORY PANEL: Potential Topic – COVID-19 (Supply Chain, Vaccines, Aseptic)
Track 1: Pharma 4.0™ in Biotechnology Accelerated by Digitalisation
Track 2: Operations Readiness, Technology Transfer and Risk based Case Studies
Track 3: Cell and Gene Therapy Products, ATMPs, Projects, Commercial Manufacturing
Track 4: Cell and Gene Therapy, ATMPs, Data Science Research and Development
Track 6: mABs: Continuous BioManufacturing, Technology Enablers & Rationalisation
Track 2: Quality 4.0 • The New Dimension of Quality Through Process and Data Science
Track 4: Trends in Engineering and Project Management
DateApril 26, 2022Presentation of Ninlaro project developed in Grange Castle IrelandSpeaker
DateApril 26, 2022ISPE published the 2nd edition of the Volume 6 Baseline Guideline on Biopharmaceutical Manufacturing Facilities in 2013. This Baseline Guideline introduced a tangible concept of modern biopharma facilities that are based on closed processing…Speakers
DateApril 27, 2022This presentation will provide an overview of the Construction, Commissioning & Qualification (C&Q) and Start Up phases of the BioCork2 Project at Janssen Sciences Ireland…Speakers
DateApril 27, 2022Adapting an innovative platform technology from the automotive industry, we established TIGER, a new tool to manage Drug Discovery projects…Speaker
DateApril 27, 2022Good planning is the prerequisite for a successful project: the technical developments of planning (from paper to AutoCAD and on to BIM) as well as the modern LEAN methods for coordination and management determine a project’s success in today’s business world…Speaker
DateApril 27, 2022Problem: Over-engineering costs a lot; however not meeting regulatory requirements costs much more. Target: To design a facility for biopharmaceutical HPAPIs that is: 1- Effective and comply with US & EU GMP and EHS regulations. 2- Efficient saving in both CapEx & OpEx…Speaker
DateApril 27, 2022mRNA is not just the basis of new COVID-19 vaccines. mRNA is also a versatile technology for the development and manufacturing of new medicinal product candidates such as cancer. As cancer is also a global health threat, BioNTech aspires to develop individualized cancer treatments…Speakers
