User:PassionateGAMPer
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 | This user has publicly declared that they have a conflict of interest regarding the Wikipedia article Draft:International Society for Pharmaceutical Engineering. |
Conflict of interest disclosure
[edit]I have a conflict of interest regarding the [[International Society for Pharmaceutical Engineering]] (ISPE) and its Good Automated Manufacturing Practice (GAMP) guidance, and I disclose it here in line with WP:COI.
I am a member of ISPE and hold the following volunteer positions in the society:
- Chair of the Global GAMP Steering Committee
- Chair of the ISPE GAMP Trainer Team
- Member of the GAMP Editorial Review Board
- ISPE-certified GAMP trainer
I have contributed as an author or co-author to several ISPE publications, including the GAMP 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (2nd edition, 2022), the GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (2017; 2nd edition 2024), and the GAMP Good Practice Guide: Enabling Innovation (2021), and I have written articles for ISPE's magazine Pharmaceutical Engineering and spoken at ISPE conferences.
My positions within ISPE are unpaid volunteer roles, and I received no fee or royalty for my contributions to ISPE guidance documents. I am not being paid by ISPE, or by anyone else, for my contributions to Wikipedia.
For completeness: I am a senior executive consultant at Q-FINITY, a consultancy working in GxP-regulated quality management and computerised system validation, and I work as a trainer in that field. My ISPE roles form part of my professional profile. So while no money reaches me from ISPE, I do have an indirect professional interest in the subject, and I am not in a good position to judge my own neutrality on it.
Because of this, I do not edit articles about ISPE or GAMP directly. I submit drafts through Articles for Creation and use edit requests on talk pages, so that uninvolved editors decide what is published. ```