Classroom 2 days
44652508
This course enables delegates to review the requirements of quality risk management, as well as familiar with various tools for quality risk management. Moreover, delegates will able to practice using risk management tools through interactive workshops.
Description
COURSE OUTLINE:
Day 1
Session 1
Course introduction
Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products
Theory session 1 and workshops on ‘introduction to GMP awareness training‘ and
‘GMP introduction’.
Session 2
Personnel: code of practice; training; qualification; responsibility; hygiene
Theory session 2 and workshops on ‘Personnel; training; sanitization & cleaning’
Session 3
Complaints& recalls/ Rejection & Returns/ Self Inspections/ Documentation
Theory session 3 and workshops on ‘Complaints and recalls; deviations; returns; self Inspections; documentation’
Session 4
Premises & equipment: qualification & validation
Theory session 4 and workshops on ‘Premises & equipment; qualification & validation’
Day 2
Session 5
Production / Labeling and Packaging
Theory session 5 and workshops on ‘Production & Process Controls / Labeling and Packaging
Session 6
Retention Sample / Control of components, containers, Materials Management
Theory session 6 and workshops on ‘Retention Sample /Control of components, containers, Materials Management’
Session 7
The GMP inspection process
Theory session 7 and workshops on ‘The GMP inspection process’
Session 8
Case study – those non-comformances raised during the inspection.
Examination
CERTIFICATION (Attendance: 80%):
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
Two years passed since Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products was issued. According to incomplete statistics, the involved companies quantity was reduced from 150 to 49 licensed by DoH. How can you survive under the current strict surveillance environment.
This intensive course aimed to addresses the latest Hong Kong GMP requirements specifically for 2nd packaging manufacturer who provides services like warehouse management, products repackaging & relabeling processes of pharmaceutical products.
The contents and the discussions will help each individual involved in manufacturing put the Hong Kong Secondary Packaging GMP requirements into practice. The situations and experiences shared will help participants to find solutions to common problems. The point of view as an auditor will enhance individuals to identify areas for improvement for their operations while enhancing a positive attitude towards the regulation.
Audience
- Distributor of Pharmaceutical Products
- Pharmaceuticals Enterprise who owned the warehouse or provide their own distribution.
- Logistical Service Supplier Involved Medicinal Products
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.)
Classroom 2 days
44652508