Hans Heesakkers is Managing Director of Circuition Life Science Consultants and past Co-Chair of the ISPE Pharma 4.0™ Special Interest Group (SIG). He has 30 years of experience in the life sciences industry, 20 years of experience in business process reengineering and IT projects, 15 years of experience in manufacturing and supply chain management, and 15 years of experience in the areas of clinical development and investigational products. He has been an ISPE member since 2004.
As Pharma 4.0™ increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources. Validation must adapt to industry shifts from iterative to...
The 2019 ISPE Europe Pharma 4.0™ Conference held in Manchester, UK, on 20–21 November 2019 was attended by 300 participants, all of whom contributed to the growing momentum for
Applying emerging technologies can lead to more robust and flexible manufacturing processes that in turn can help the pharmaceutical industry respond to drug shortages, reduce interruptions in production and delivery of medicines, ensure consistent clinical performance of products, and achieve other benefits. Although some may believe that regulators are averse to the use of emerging...