Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 2: Digital Data, Insights, Metrics and Analytics (Hardcover)

Jan 2021
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This second of two volumes details how pharmaceutical and healthcare manufacturers have ben embracing digital technologies as part of the transformation of their business models. It contextualizes current developments and future advancements in terms of the COVID-19 situation of 2020 and specific measures that were taken.

Topics and laboratory functions that will be explored include:

  • New model healthcare
  • Ways to use digital data, including root cause investigations
  • Office technology
  • Protecting ownership security
  • E-learning and virtual inspections
  • And many more

The first volume of this two-part collection addresses building a digital company, big data analytics, advances in Process Analytical Technology electronic batch records, Block Chain, and more. Taken together, these volumes provide a clear picture of where things currently stand, where they are likely to develop, and the challenges that digital technology adopters face, in terms of practicalities and in maintaining GMP compliance.

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: Transforming Data Analytics and the Laboratory Through Digital Technology and the New Workplace Culture
  2. Digitalizing the Laboratory: From LIMS to Automated Instrumentation
  3. Automating the Laboratory
  4. Digital Laboratory in Practice: Rapid Microbiological Methods
  5. Developing Trends with E-Learning in the pharmaceutical Workplace
  6. Approaching the Virtual Regulatory Inspections: What to Expect, How to Prepare and How to Participate
  7. Digital Transformative Technologies for the Pharmaceutical Sector Office
  8. Data Integrity Considerations for the Digital Transformation Wave
  9. Call from Afar: Telehealth and the Communication of Health
  10. Digital Data: Researching, Searching, and Handling
  11. Questions to Answer? Data Privacy, Data Ownership, and Data Security
  12. Why Digital Transformation Projects Fail (And How They Might Succeed)

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.