DESCRIPTION
The course addresses the pharmaceutical product supply chains for human medicines, from the producers of raw materials to manufacturers of finished products.
The contents and the discussions will help each individual involved in GMP understand where their contribution fit into the GMP framework within an organization and how different departments function together with protecting quality, safety and efficacy of the pharmaceutical products as the responsibilities of all parties involved. Consequently, it helps the participants understand the reason for observing GMP rules and develop a positive attitude towards GMP.
COURSE OUTLINE:
The regulatory and legislative GMP guidance have a large impact on the manufacture of pharmaceutical products. Therefore take the advantage of this training course to share and discuss the guidance and experiences within the industry!
| 1. Regulations in Europe | 2. Regulations in the USA | 3. Harmonised Regulations |
| 4. GMP in Manufacturing | 4. GMP in Manufacturing | 6. Documentation (Report & Record) |
| 8. Chang Management | 8. Chang Management | 9. Self-Inspections |
| 10. Performance of Self Inspections | 11. GCP – Clinical Trials Introduction | 12. Test (M.C.) |
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
AUDIENCE
The course is designed for individuals of all levels within a
- Pharmaceutical Manufacturing Organization.
- QA, QC, Production as well as RA and General Management Positions
- will be able to better understand the issues at stake as per GMP requirements.
Classroom 1 DAY
44652507