GMP Continuing Professional Development Programme for Authorized Person of Secondary Packaging
(Quality Assurance Officer) or Person in charge of Secondary Packaging
Course Code:CPD/L/10/2023/C2301
Category: IA
Course Title:Good Distribution Practice and Management of Secondary Packaging Facilities
CPD Hours : 7
A. Learning Objective :
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Understanding of Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Distribution Practice for Medicinal Products (PE011-1 issued on 1 June 2014),
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Understanding on key quality requirements for a computerized Warehouse Management System (WMS).
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Understanding on key quality requirements for management of coldchain pharmaceutical products.
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Understanding key requirements for good delivery practice of pharmaceutical products.
B. Course Tutor: Mr. Chan Pui, John is a registered pharmacist and currently working as the QA and RA head of one of the biggest Pharmaceutical distributors in HK. He has been working in the pharmaceutical/healthcare industry as quality assurance and regulatory affairs professional for 14 years and he is a Hong Kong Pharmacy & Poison Board qualified Authorized Person for GMP production.
C. Course Content:7 hours lecture + 1 hour assessment
Item
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Lesson Topic
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Tutor
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1.
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Good Distribution Practice (GDP)
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Mr. Chan Pui
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2.
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Computerized Warehouse Management System (WMS)
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3.
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Coldchain Management
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4.
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Good Delivery Practice
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5.
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Exam (1 hour)
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D. Target Groups
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Registered Authorized Person of Secondary Packaging
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Person in charge of secondary packaging
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Pre-Reg. Pharmacist
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Employees of pharmaceutical Secondary Packaging Manufacturers
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Employees of pharmaceutical manufacturers
E. Language
● The whole course will be conducted in Cantonese with English notes
● Exam paper is bilingual in English and Chinese
F. Assessment
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Multiple Choice Exam
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Pass mark 60%
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Attendance of 100%
G. Venue: PSHK Headquarter
● Room 1303, Rightful Centre, 12 Tak Hing Street, Jordan, Hong Kong
H. Certificate
● CPD course certificate:Participants will be awarded with the CPD certificate if he/she can pass the exam and with 100% attendance
● Participants can apply for attendance certificate if he/she cannot pass/ will not attend the exam
I.Fee
● Course Fee– HKD 2,700.00
● Exam Fee* – HKD 500
*Participants who wish to obtain the CPD hours must attend the Exam.
J. Date and Time
● Course Date: 14 Oct 2023 , 9:30am - 6:30pm (including lunch 12:30-13:30) and
● Exam Date: 14 Oct 2023(1 hour)
K. Course Enrolment :https://forms.gle/XG48RiXnUfD7X2WY9
L. PaymentMethods
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By Cheque - Please make cheque payable to 香港藥學會 /The Pharmaceutical Society of Hong Kong”
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ByBank Transfer - To “The Pharmaceutical Societyof Hong Kong” HSBC BankAccountNo.: 004-002-2-163166,and send yourPay-In Slip/Receipt byEmail to : admin@pshk.hkor by Fax - 2376 3091
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FPS - FPS ID: 101477735
M. For Enquiry, please send to Email: admin@pshk.hk
N. Enrollment DeadlineDate: October 7, 2023