Live Online Training - China GMP and Registration for APIs

Tuesday, 20 October 2020

Course No. 18485

header-image

Speakers

Francois Vandeweyer

Francois Vandeweyer

VDWcGMP Consulting

Marieke van Dalen

Marieke van Dalen

MARA Consultancy, The Netherlands

All times mentioned are CEST.

Objectives

In a relatively short period of time, China has become the leading global supplier of APIs in terms of volume. China is the world’s leading producer and exporter of active pharmaceutical ingredients (APIs) by volume, accounting for 20% of total global API output. According to WHO China produces over 2000 APIs, with annual production capacity exceeding 2 million tons.1

China first introduced GMP in 1988, and the latest GMP regulations are the 2010 revised edition of Good Manufacturing Practice for Pharmaceutical Products (with effect from 1 March 2011). While CFDA is responsible for developing regulations and standards for GMP, it is mainly provincial and local authorities that are responsible for inspection and certification.1

The understanding of GMP and Registration Procedures for APIs are thus important to know and understand.

This online training course provides an overview of the legal requirements regarding APIs in China.

1Source: WHO Report https://www.who.int/phi/publications/ 2081China020517.pdf?ua=1

Target Group

This online training course has been developed for all who are dealing with API Sourcing, Manufacturing, Quality Assurance and Regulatory Affairs.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programme

Live Online Training - China GMP and Registration for APIs

Seminar Programme as PDF

API Registrations in China
Marieke van Dalen
  •  Health authorities in China
  •  The Chinese Drug Master File system
  •  Bundled review
  •  Specifics for the Chinese API Drug Master File
  •  Common deficiencies
China Current View on Drug GMP
Francois Vandeweyer
  •  Chinese GMP main topics
  •  Chinese Drug GMP on site inspection focus points
  •  Chinese GMP annexes with focus on Biologicals
  •  Chinese quality management and equipment strategy to compete with the West

This training/webinar cannot be booked. Send us your inquiry by using the following contact form.

To find alternative dates for this training/webinar or similar events please see the complete list of all events.

For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.

* also payable by credit card
American Express Visa Mastercard

icon
Further dates on-site
Further dates on-site
Not available
icon
Further dates online
Further dates online
Not available
icon
Recording
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org

Woman with headset

Go back

Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023

 

“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024

 

“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024

 

 

“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023