Resolving Quality and Compliance Challenges in a GxP World
ISPE GAMP® Activities and Awards
ISPE Qualified Instructor for GAMP® Training Courses
ISPE Qualified Instructor for GAMP® Training Courses
ISPE Qualified Instructor for GAMP® Training Courses
Charlie has successfully met all the requirements set by ISPE and is a Qualified Instructor for the following ISPE GAMP® Training Courses:
- GAMP® Basic Principles 2-Day Training Course (T07)
- GAMP® Basic Principles 3-Day Training Course (T45)
- GAMP® Data Integrity 21 CFR Part 11, 3-Day Training Course (T50)
- GAMP® Data Integrity 21 CFR Part 11, 2-Day Training Course (T70)
GAMP® Global Steering Committee - Chair
ISPE Qualified Instructor for GAMP® Training Courses
ISPE Qualified Instructor for GAMP® Training Courses
In October 2023, Charlie was elected to Chair of the GAMP Global Steering Committee, leading the 5,000 member GAMP Community of Practice dedicated to the compliant use of computerized systems in regulated environments.
ISPE Annual Meeting Planning Committee
ISPE Qualified Instructor for GAMP® Training Courses
ISPE Annual Meeting Planning Committee
The ISPE Annual Meeting, held alternately on the East and West coasts of the US, is the flagship conference event within ISPE. Charlie joined the Planning Committee by invitation for the 2022 Annual Meeting and again for the 2023 meeting, working with a team of specialists to select sessions and mentor presenters to ensure a successful conference.
GAMP® Global CSA SIG
ISPE Guidance Documents Committee
ISPE Annual Meeting Planning Committee
Charlie set up a GAMP Special Interest Group on Computer Software Assurance in 2022. The SIG hosts quarterly meetings to share real life experiences and case studies, and to debate complex questions around the use of CSA.
2022 ISPE Committee of the Year
ISPE Guidance Documents Committee
ISPE Guidance Documents Committee
The GAMP Global Steering Committee won Committee of the Year in the 2022 ISPE International Honor Awards, in recognition of its successful revision of GAMP 5 guide. Charlie was both Secretary of the Committee at that time and a contributing author to the guide.
ISPE Guidance Documents Committee
ISPE Guidance Documents Committee
ISPE Guidance Documents Committee
Charlie has served on the Guidance Documents Committee since 2022. GDC are the gatekeepers for proposals for new good practice guides, providing steering for guide production and subject matter expert reviews of guide content before publication. ISPE has more than 65 published guidance documents.
2019 ISPE Member of the Year
GAMP® Data Integrity SIG / 2017 Committee of the Year
GAMP® Data Integrity SIG / 2017 Committee of the Year
Each year, ISPE awards the Max Seales Yonker Member of the Year award to the ISPE Member who has made the most significant contribution to the Society during the past 12 months. Charlie was awarded Member of the Year for her work training regulators in the APAC region.
GAMP® Data Integrity SIG / 2017 Committee of the Year
GAMP® Data Integrity SIG / 2017 Committee of the Year
GAMP® Data Integrity SIG / 2017 Committee of the Year
The GAMP DI SIG ran for over five years with several hundred members. The SIG provided a discussion space, an education platform, and practical solutions around data integrity. During the life of the SIG, four good practice guides were produced. Charlie and her SIG co-leaders (Lorrie Schuessler, Mark Newton, Nigel Price, Christopher White) won Committee of the Year in 2017 for the exceptional work of the SIG.
GAMP® Europe Steering Committee
GAMP® Data Integrity SIG / 2017 Committee of the Year
GAMP® Europe Steering Committee
Charlie served as Secretary of the GAMP Europe regional steering committee from 2011 until her departure to Australia in 2013. GAMP Europe provided alignment and direction for the 12 local GAMP groups operating within Europe.
GAMP® UK Forum
GAMP® UK Forum
GAMP® Europe Steering Committee
Charlie was one of five founder members of GAMP UK in 2009. As Secretary, she would arrange the twice-yearly forum meetings - funded through corporate sponsorship and free of charge to ISPE members - as well as the Steering Committee meetings and liaison with the ISPE UK Affiliate. For the four years she served on GAMP UK, every forum meeting was filled to capacity with sponsor companies lined up a year in advance.
Pharmaceutical Engineering and iSpeak Blog Links
Note: Some links are only accessible to ISPE Members
Copyright © 2023 WakeUp to Quality - All Rights Reserved.
GAMP is a trademark of the International Society for Pharmaceutical Engineering (ISPE)
Powered by GoDaddy
This website uses cookies.
We use cookies to analyze website traffic and optimize your website experience. By accepting our use of cookies, your data will be aggregated with all other user data.