Description
COURSE STRUCTURE:
1.Quick review of the GDP requirements
2.Planning and organizing audit
3.Responsibilities and skills of auditor
4.Objective collection and analysis of evidence
5.Evaluation and reporting of audit results
6.Case study
7.Practical workshop
8.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
Good Distribution Practices (GDP) Auditing & Inspection Skills Course enables delegates to familiar with the processes of auditing (PDCA) and requirements for auditors and inspection skills for pharmaceutical industry.
Through this course, delegates will be able to arrange and implement various audit. Moreover, they will enable to interpret the requirements of GDP from the prospect of auditors/inspectors and familiar with the expectation of inspectors.
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
- Registered Authorized Person, Quality Assurance Officer and Person In Charge for secondary packaging in Pharmaceutical industry
Classroom 1 Day
44653141