COURSE OUTLINE:
1.Introduction
2.Definitions
3.Data governance system
4.Organizational influences on data integrity
5.General data integrity principles and enablers
6.Specific data integrity considerations for paper-based systems
7.Specific data integrity considerations for computerized systems
8.Data integrity considerations for outsourced activities
9.Common deficiencies
10.Quiz
PROFESSIONAL TRAINER:
Worked in pharmaceuticals industry field for more than 9 years, with experience across R&D, Registration Regulation, Production Technique, Quality Control and Quality Assurance. Specially, in the past 4 years, experience focused on cGMP system research and development, going through GMP guideline of FDA, PIC/S, and other international regulation e.g. GMP for cosmetics, GMP for dietary supplements, ISO 22716, ISO 15378etc. related to pharmaceutical industry, cosmetic industry and dietary supplement industry field.
(SGS Hong Kong Ltd. reserves the right of final tutor arrangement.)
CERTIFICATION (Attendance: 100%):
Delegates who successfully completed the course will be issued a certificate by SGS Hong Kong Limited.
GENERAL INFORMATION:
Venue: T.S.T. / Wan Chai / Sheung Wan Training Centre / TBC
Medium: Cantonese supplemented with English material
*Early Bird Price will be offered to participant whose enrolment is made one month prior to the course or online booking