After the successful development of equipment cleaning process cycle, the next step is to validate the cleaning process through cleaning validation. A sound cleaning validation strategy and approach is critical in ensuring the successful completion of cleaning validation. This presentation examines the critical factors in cleaning validation and explores how digitalization and data analytics are streamlining cleaning validation processes, minimizing human error and accelerating time-to market for pharmaceutical products.
At the end of the seminar, the participants will have a better understanding of the important considerations when performing cleaning validation. This will lay the groundwork to a successful cleaning validation.
As a Senior Technical Service Manager with STERIS Corporation based in Singapore, Richard has been providing technical support and training to customers related to bioburden control for cleanrooms, as well as cleaning and cleaning validation for product contact surfaces. He is also a frequent industry speaker at industry events such as ISPE, and co-author of PDA book chapter. Richard has more than 20years of manufacturing, validation and consultancy experience working in various pharmaceutical companies.
Vivien is the Regional Director for Asia of Novatek International. She is an accomplished Technical Sales Director, Business Development and Marketing professional with more than 25 years of experience in the information technology and services industry. She has been assisting pharmaceutical companies for the past 17 years in achieving regulatory compliance by providing technical assistance, gap analysis, computer system validation, documentation and training in the implementation and use of LIMS, digital QMS and Contamination Control solution.
Vivien served as President of the Philippines Affiliate (2017-2020) and Chair of the Asia Pacific Council (2019-2020). She is a member of several ISPE Community of Practice (COP) Steering Committees, such as the Drug Shortages Initiative Team and QC/ Analytical. She is also the current Chair of ISPE Women in Pharma® International Steering Committee and Co-Chair of ISPE GAMP South-Asia. Vivien has spoken and conducted trainings to the regulatory and industry on topics on computer system validation, data integrity and digitalization.
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