Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 1: Digital Technologies for Automation and Process Improvement

Oct 2020
PDA Item Number
Hardcover 17361 | Digital 18083
Member Price
Nonmember Price

This first-of-two volume release from prolific author Tim Sandle fills an important void by taking an in-depth look at the way digital technologies are impacting the pharmaceutical and healthcare landscape both now and into the future. He explores how companies have been embracing digital technologies as part of the transformation of their business models.

The disruption caused by the digital transformation of pharmaceuticals and healthcare is not static; it is evolving, and it will continue to evolve. Across the informative and substantive chapters, this book takes stock of the current technological landscape, where it is likely to develop, and the challenges that adopters face, in terms of practicalities and in maintaining GMP compliance. It explores what each technology does, the potential use of the technology, and the practical aspects for its implementation.

Yet, digital transformation is not just about technology. The process also concerns changes to culture and structure, the understanding of which is presented in this book and is critical for those working in the pharmaceutical sector.

The themes covered in this first volume are process-centric and include blockchain and track and trace technology, fostering the digital pharmaceutical company, and building efficiencies through real-time metrics and Process Analytical Technology. The second volume will address the digitization of the laboratory and a survey of data handling issues.

Regulatory aspects and standards are addressed throughout each of the two volumes.

Digital transformation has been taking place and is now taking place at an accelerating pace. With this book, you will develop an understanding of what is (and has been) happening and why.

Save 10% when you buy both Volume 1 and Volume 2 in the same format. Discount applied at checkout once both volumes have been added to your cart.

Table of Contents

Table of Contents:

Click here to download >>>Detailed Table of Contents

  1. The New Normal? Digital Technologies and the Transformation of Pharmaceuticals and Healthcare
  2. Automating the Process and Fostering the Digital Pharma Company
  3. Big Data Analytics: Collecting Process and Product Centric Data
  4. Real-Time Metrics: Advances with Process Analytical Technology
  5. Ultimate Preventative Measures? The Use of Predictive Analytics Technology
  6. The New Vision Use of Digital Twins and Virtual Reality
  7. Securing Data Collection: Adoption of Wireless Technology and Cloud Computing in Pharma
  8. Key Considerations for the Adoption and Operation of Electronic Batch Records
  9. Artificial Intelligence and the Drug Development Process
  10. Blockchain, Track and Trace Technology and Counterfeit Medicines

Glossary of Digital Transformation Terms

About the Authors

About the Author

Dr. Tim Sandle has over 25 years' experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology and Sterility Assurance at Bio Products Laboratory, UK and a visiting tutor with the School of Pharmacy and Pharmaceutical Sciences, University of Manchester. In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control, including the Pharmaceutical Microbiology Interest Group (Pharmig) and PDA technical working groups. He is also a member of several editorial boards for scientific journals. Dr. Sandle has written over 600 book chapters, peer reviewed papers and technical articles relating to microbiology. These include the DHI/PDA books Sterility Testing of Pharmaceutical Products, Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies, Cleanroom Microbiology, Aseptic and Sterile Processing: Control, Compliance and Future Trends, and Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers, as well as the books Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control and Biocontamination Control for Pharmaceuticals and Healthcare.