
Description
COURSE OUTLINE:
- Introduction of GDP
- Introduction of organizations related to GDP (WHO, PIC/S, EU, DoH, USP)
- GDP Basic Requirements
- Quality Management
- Personnel
- Premises and Equipment
- Documentation
- Operation
- Complaint, Returns, Suspected Falsified Medicinal Products and Medicinal Products Recalls
- Outsourced Activities
- Self-inspections
- Transportations
- Different requirements between regions
- Workshops
- 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
The safety of pharmaceutical products is of increasing concern, with transportation & storage being one of the main process prior to consumption by patients, the quality of the pharmaceutical products in the supply chain must be assured. SGS Hong Kong is committed to the local promotion of GDP combining the best practice of other countries for customers to achieve continuous improvement.
This course enables delegates to have a brief overview of the basic requirements of GDP in various regions around the world and able to familiar with the requirements through workshops within one single day. Also, this course can enable delegates to prepare their organization for adapting the PIC/S GDP requirements.
Audience
Distributors/ Wholesalers of pharmaceutical products; Pharmaceuticals enterprise who owned the warehouse or provide their own distribution; Logistical service supplier involved pharmaceutical products; Third party logistics who handle pharmaceutical products; Any enterprises who provide distribution, repackaging and logistical service in pharmaceutical supply chain.
