In this issue:
•
ISPE 2015 Upcoming Events
•
Jan-Feb member gift package is available now
•
ISPE Volunteer Recruitment
•
ISPE Publications Recommendation
Events:
ISPE 2015 Upcoming Events
2015 ISPE China Annual Spring Conference (Apr 20-21, Beijing)
Speakers and program have been updated at Conference website. Embracing the latest technologies and
engage in meaningful discussions with over 90 experts from leading Pharmas and regulatory agencies.
Speakers at a glance:
• Larry Lee | Acting Associate Director of OPQ, FDA
• Jeff Gelwicks | Senior Director of Global Quality Laboratories, Eli Lilly
• Dinesh Thakur | Executive Chairman of Medassure Global Compliance Corporation
• Ganapathy Mohan | Head of Global CMC Regulatory Affairs (Small Molecules), Merck
• Gang Wang | Assistant Country Director, U.S. FDA China Office
• Wenjun Tang | Research Professor of Shanghai Institute of Organic Chemistry
• Daniel Song | Director of CMC Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Register now and enjoy Group Rate (5 or more than 5 persons in one company)
Sponsors and exhibitors don't miss this opportunity to interact with key decision-makers and buyers from the
global pharmaceutical manufacturing industry at this "must-attend" event! Download the sponsorship plan to
learn your benefits.
2015 ISPE China Training Calendar
• 14-15 May, Qingdao

Environmental Control And HVAC For Life Science Facilities

Oral Solid Dosage Forms: Understanding the Unit Operations, Process, Equipment and Technology for
OSD Manufacture

Applying Quality Risk Management (QRM)

Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide:
Applied Risk Management for Commissioning and Qualification

Practical Application of Computerized Systems Compliance--- Applying the GAMP® 5 Guide: A Riskbased Approach to Compliant GxP Systems
• July, Shanghai
July 20-21

Process Validation Lifecycle - Integration to the Pharmaceutical Quality System

Practical Application of Computerized Systems Compliance

Applying Quality Risk Management (QRM)

Science and Risk-based Commissioning and Qualification - Applying the ISPE Good Practice Guide:
Applied Risk Management for Commissioning and Qualification
July 22-23

Facility Project Management in the Regulated Pharmaceutical Industry

Turning QbD into a Practical Reality

GMP Auditing for the Pharmaceutical Industry

Oral Solid Dosage Forms: Understanding the Unit Operations, Process, Equipment and Technology for
OSD Manufacture
Click here for detailed information
Note: We will only choose 2-3 trainings every time per registration status
Membership Zone
Jan-Feb member gift package is available now
As one of key membership benefits, Monthly gift includes the hot information, frontier technical articles and
industry reports around the globe. Meanwhile, ISPE China also provides ISPE members with a local monthly
gift including local valuable contents/knowledge. ISPE members are able to download this gift package at the
beginning of every month on ISPE China Official Website.
HQ’s monthly gift（These will be available to you by Feb 28, 2015)

How Type I Error Impacts Quality System Effectiveness
China’s monthly gift - 2013 ISPE China Annual Conference presentation slides (6)
（ These will be available to you by March 7, 2015 )

IVIVC - Challenges & Considerations

Key Point for Chinese New GMP Inspection
Notice: Don’t miss your membership benefits.
Volunteers Zone
ISPE Volunteers recruitment
Volunteers always play a vital role in ISPE’s development. You can join ISPE committees, the task group, or
community discussion groups to be our volunteers, and share your knowledge, experience and perspectives
with others. (ISPE member only) ISPE is now recruiting the volunteers for ISPE pharmaceutical engineering
magazine articles’ translation. Volunteers should have relevant knowledge and background. If you want to join
us, please contact Viona: 021-2312-3521 or email china@ispe.org .
ISPE Publications Recommendation:
Produced by pharmaceutical manufacturing industry professionals, ISPE Guidance Documents provide the
practical, "real world" information you need to help your company build on current best practices to meet and
exceed regulatory standards.
ISPE Good Practice Guide: Cold Chain Management
Increasing volumes of cold products, the complexity of these products, and the complexity of the associated
supply chain are causes for concern. Organizations need adequate control over cold chain of pharmaceutical
and biopharmaceutical distribution systems. ISPE recognized the need for guidance in this area a dedicated
team of subject matters experts from across the pharmaceutical and biopharmaceutical industries developed
the ISPE Good Practice Guide: Cold Chain Management.
ISPE Good Practice Guide: Process Gases
The ISPE Good Practice Guide: Process Gases aims to define current good practices within pharmaceutical
manufacturing applications, providing information to allow organizations to benchmark their practices, and
improve upon them.
This Guide considers gases that come into direct contact with the biopharmaceutical and pharmaceutical
manufacturing process streams, including: nitrogen, oxygen, argon, carbon dioxide, compressed air etc.
These process streams include bodily contact surfaces of invasive medical devices and fluid paths of medical
devices that are used for intravenous solution, blood, or other critical applications to administer life saving or
sustaining fluids.
For more information about ISPE publications, please visit ISPE official website or contact 021- 2312 3640 /
china@ispe.org.