Price and confirmation:

  • The price is in HKD 6,000 (or USD 800) per person, with small class approach.
  • The course is subject to confirmation by email, with condition of 3 to 6 participants in total.
  • If the dates are not suitable to you, you can propose other dates for confirmation with us.

Language:

  • Lecturing in Chinese with training materials in English, unless otherwise agreed in writing.

Target

  • To understand the basics of EU Guidelines on Good Distribution Practice for pharmaceutical products for human use (EU GDP)
  • To understand the principles of quality management in EU GDP
  • To understand the requirements for logistics in EU GDP
  • To develop the basic expertise to implement a QMS according to EU GDP
  • To develop the basic expertise for internal audits (for Internal Auditor Course) 

Agenda

  • Introduction
  • Quality management
  • Personnel
  • Premises and equipment
  • Documentation
  • Operations
  • Complaints, returns, suspected falsified medical products and medicinal product recalls
  • Discussions and Exercises
  • Q&A
  • Outsourced activities
  • Self-inspection
  • Transportation
  • Specific provisions for brokers
  • Final provisions
  • Workshops
  • Q&A
  • Internal Audit  
        (only for Internal Auditor course)
  • Exam

Content

  • Lecturing
  • Discussions, exercises and workshops
  • Q&A
  • Open-book Written Exam
  • Certificate in pdf

Moderator

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Course Lecturer of DQS HK
Moderator
Lecturer with solid experience in audits and training.

EU Pharma GDP Internal Auditor Training

Location
Hong Kong
Language
Material in English, Lecturing in Chinese
Date
Sep 19 , 2022 9:30-17:00
Sep 20 , 2022 9:30-17:00

6000

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