Good Practices for Data Management and Integrity Course in Pharmaceutical Industry

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Description

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

Objectives

Data integrity is one of the biggest concerns by competent authorities and hence the biggest challenge the industry will be facing in the coming few years. This course introduces and interpret the principle and global guidelines on data integrity, introduces good documentation practices (GDocP) / ALOCA, and  shares common deficiencies.

Through this course, delegates will be able to familiar with the latest international guidelines and how inspectors look into data integrity control. 

Audience

  • Manufacturer of pharmaceutical products
  • Distributor of Pharmaceutical Products
  • Third party logistics who handle pharmaceutical products
  • Any enterprises who provide raw materials, starting materials, distribution, repackaging, logistical and related service in pharmaceutical supply chain
  • GXP inspectors

View Details

44653245

1 day

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