On behalf of the ISPE Special Interest Group (SIG) “Pharma 4.0 and Holistic Manufacturing Control Strategy”, join us to attend the ISPE 2017 Europe Pharma 4.0 Conference, taking place 23–24 November in Verona, Italy. Register now for two days of premier education and networking opportunities as we explore our event theme:
From Industry 4.0 to Pharma 4.0
According to Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA), the vision of pharmaceutical quality for the 21st century is “a maximally efficient, agile, and flexible pharmaceutical manufacturing sector that reliably produces high quality drugs without extensive regulatory oversight.”
Based on this FDA vision, the SIG Pharma 4.0 created its mission to “manufacture pharmaceutical products with maximum product and process understanding, data integrity by design, efficiency, and optimal resource allocation on the basis of full digital data transparency—to the benefit of the patient.”
Taking on this challenge, the SIG Pharma 4.0 is working on practical approaches to enhance the Control Strategy to a “Holistic Manufacturing Control Strategy.” Based on the ICH Guidelines, this will cover the entire pharmaceutical life cycle from pharmaceutical development, technology transfer, commercial manufacturing, up to product discontinuation.
The ISPE 2017 Europe Pharma 4.0 Conference offers a unique platform to discuss the four key aspects of Pharma 4.0 in four dedicated tracks and develop a pragmatic and beneficial approach for the pharmaceutical industry. By bringing together industry, suppliers, academia, and regulators we will offer a cross functional and even cross branch approach to this issue as well as discussion on how we can break down existing silos.
For more information and to register, please visit the conference website.
I am looking forward to seeing you in Verona to discuss how to make Industry 4.0 transition to Pharma 4.0, taking the regulation, qualification, and validation aspects in the pharmaceutical industry.