Charlie C. Wakeham
Director
WakeUp To Quality

Charlie 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. 

Overview

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:

  • Understanding of risk management approaches to data integrity
  • Overview of the new GAMP® Good Practice Guides:
  1. Practical Approaches to Data Integrity Key Concepts
  2. Practical Approaches to Data Integrity in Manufacturing Systems
  • Confidence to apply industry best practices and mitigation strategies for data management and accountability

NB - Attendees will qualify for a 20% discount† when ordering these two GAMP guides. 

Location:

Holiday Inn, Auckland Airport
2 Ascot Road Auckland Auckland 2022, New Zealand

Who Should Attend?

Quality and validation specialists, engineers, technical professionals, managers and vendors who develop, use, support or validate GxP computerized systems.

AGENDA

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
10:30– 10:45 Break
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

NB – Final program subject to change without notice

Register