DESCRIPTION
COURSE STRUCTURE:
- Introduction
- General Principles
- Basic Requirements
- Critical Elements in quality risk management
- pplicable Tools
- Common deficiencies
- GMP/GDP Case Study
- 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.)
REFERENCE STANDARD:
Delegates who successfully completed the course will be issued a certificate by SGS Hong Kong Limited.
CERTIFICATION (Attendance: 100%):
PIC/S GMP Guideline Annex 20 & ICH Q9
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, as risks emerging from everywhere in the manufacturing, packaging, warehousing and distribution processes. The risk management beginning with pharmaceutical starting materials to finished products must be assured. SGS Academy is committed to the local promotion of GMP and GDP combining the best practice of other countries for customers to achieve continuous improvement. This course enables delegates to have a close look on requirements, tools and difficulties for quality risk management.
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
Classroom 1 DAY
44652506