Charlie Wakeham has 20 years of industry experience developing and validating computerized systems for regulated production and laboratory environments. Charlie is a member of GAMP® Global Council and GAMP® Data Integrity Special Interest Group Leadership Team, and she is co-author of the ISPE GAMP Records and Data Integrity Guide published in 2017 and co-lead on two new GAMP data integrity practical approach guides publishing in 2018. She is Waters Corporation's Regional CSV Consultant, providing validation services and compliance expertise to regulated companies throughout the APAC region.
This one-day event combines presentations and interactive sessions to provide attendees with hands-on experience in applying practical approaches to data integrity.
Take Back to Your Job:
NB - Attendees will qualify for a 20% discount† when ordering these two GAMP guides.
|08:30 – 09:00||Registration|
|09:00 – 09:05||Welcome & Introductions|
|09:05 – 10:30||GAMP Good Practice Guide: Practical Approaches to Data Integrity Key Concepts|
|10:45 – 12:15||Workshop: Site Assessment Planning and Remediation of Computerized Systems|
|12:15 – 13:00||Lunch|
|13:00 – 14:30||GAMP Good Practice Guide: Practical Approaches to Data Integrity in Manufacturing|
|14:30 – 14:45||Break|
|14:45 – 16:15||Workshop: Identifying and Mitigating Risks within the Manufacturing Data Life Cycle|
|16:15 – 16:30||Wrap Up & Close|