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