Originally a chemical engineer, he has a master’s degree in advanced manufacturing systems and more than 30 years of industry experience, the majority focused on CSV across all the GxPs, with experience in steriles, primary and secondary manufacturing, and research and development in preclinical, clinical, pharmacovigilance, and manufacturing. Thana is an experienced auditor and practitioner of CSV projects, ranging from spreadsheets to systems, applications, and products (SAP), laboratory, clinical, process validation (PV), and process control systems.
An ISPE member since 2001, Thana is currently Co-Chair of the ISPE GAMP® Global Steering Committee where he also served as secretary. He is a former Chair of the ISPE GAMP® CoP Europe Steering Committee, a member of the ISPE GAMP® CoP UK, eClinical Special Interest Group (SIG), and Computer Software Assurance (CSA) SIG. He was also a member of the team that wrote ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition).
How Did You Become Interested in the Pharmaceutical Industry?
During my university degree in chemical engineering, I did a placement at Dutch State Mining in their biotechnology research area and then decided on taking the module in biotechnology. The thought of being involved in helping people become healthier is the reason to get up every morning and go to work.
What Was Your First Job Out of College?
After I earned my master’s degree in advanced manufacturing systems, I had the opportunity to get a role at Roche in their steriles manufacturing department.
Tell Us About a Project You’re Most Proud Of.
I’m most proud of the data integrity program I helped initiate and co-led with my colleague to ensure all the high-risk processes were assessed and action plans developed and tracked.
What Do You Enjoy Most About Your Work?
The variety—no one day is the same. Some tasks are indeed repetitive (e.g., monthly reporting). But each day brings a different challenge.
What Advice Would You Give Emerging Leaders?
Be flexible, be humble, and be inquisitive. Don’t think your path only goes in one direction; be flexible enough to change and adapt. Don’t assume you will always be given something, be humble and be thankful when you are given an opportunity, and always say please and thank you. I think it goes miles if you say please and thank you. Be inquisitive and always be learning. And don’t just educate yourself; help educate other people as well.
What Do You See Next for Your Area in the Pharmaceutical Industry?
The biggest area for digital quality is AI. How this actually impacts the way we are doing things today is still evolving. But the technology world is always evolving, helping make things easier and quicker and hopefully more accessible to patients. If the typical cycle of pharma drug development can be reduced using technology, then I hope we can get product-to-market approval quicker. If technology can help the way products are manufactured speed up getting the product to the patient, then there are so many pluses. I remember attending a futuristic view of pharma supply chain where you would go to bed, your body would be scanned, and during the night your personalized pill would be 3D printed for you to take in the morning!
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