ISPE China Training Committee
Table of Contents
ISPE Training Committee Overview
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Organization Structure
Training committee achievement in Past years
Training committee objectives
Training Road map
Training course Market Potential planning in three Years’
ISPE China Training Review
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Hot topics investigation result 2013
Contacts
Roles and Responsibilities
Local Trainer Development
ISPE 培训委员会组织结构
ISPE Training Committee Org. Structure in 2015
Chair
Pete Xie
Co-Chair
Wesker Xu
ISPE Staff
Melody Hu
GAMP
Lin Hong
(lead Public Training)
BioPharma
Pete/Xie Jingjun
(lead In-House
Training)
Wu Jun
Zhuansun Yan
TCM(Planning)
Zhang Jinwei
ISPE 培训委员会目标
ISPE Training Committee Objectives
Vision
Mission
Task
• Increase ISPE brand awareness & drive ISPE membership
growth by training business with our innovative portfolio
and our excellent instructor and SMEs.
•Identify and develop courses that meet local market needs
and decide the training course by collaborative operation
with other committees, special align with Technical
committees.
• execute all the defined actions/measures and advance
gradually growth target
• 50~55 candidate for each course
• 30% membership from candidate of each curse
ISPE 培训委员会目标
ISPE Training Committee Objectives
•提升的ISPE品牌意识和推广ISPE培训课
程到台湾，香港以及海外
•公益活动，加强协会与政府沟通
•开发与其他协会的合作课程
•Expand the ISPE brand awareness and
bring ISPE training course to Taiwan,
HongKong and oversea
•Public welfare activities, to strengthen
the Association and government
communication
•Development cooperation training
programs with other associations
•实现培训课程的财务盈利
•Make the training progress financially
sound
客户
流程
Customer
Process
财务
讲师/主题专家
Financials
Instructor/SME
•确定和开发满足当地市场需求的课程，
•推动教育计划,决定三年的培训主题
•拓展集团企业的内需课程
•发展在线培训课程
•Identify and develop courses that meet
local market needs and decide the
training topics in 3 Y
•Drive educational programs
•Outreach the companies to identify
needs for in-house training
•Develop on line training course
• 发展15名左右本地合格的讲师，2015
年年底开课数达10 -12.
吸引更多的主题专家成为志愿者
•Develop about 12~15 Qualified Local
instructors to cover 10 -12 topics by the
end of 2015
•Attract more volunteer as SME
Auditing for
GMP
Shen Qing
Rory
Budihandojo
Jack Qin
Water
HVAC
Gordon
Farquharson
Yang Yixing
Gordon
Farquharson
Basic Principles of
Computer System
Compliance
Practical Application
of Computerized
Systems Compliance
GAMP5&Annex11,
CFR 21 Part11
Lin Hong
Sion Wyn
Tracy L. Clemmer
Lin Hong
Sion Wyn
Lin Hong
Biopharmaceutical
Manufacturing
Facilities
Nick Kotlarski
Oral Solid
Drug Manufacturing
Dosage Forms
Facility Design and
Development
Lei Jifeng
Rob Walker
Gordon Farquharson
QRM
Li Hongyang
Sterile Drug
Manufacturing
Facilities
Wu Jun
Gordon Farquharson
Q&C
Cleaning
validation
Peter Ma
Rob Walker
Training course Market Potential planning in three Years’
• Objectives
Customer：
•Expand the ISPE brand awareness and bring ISPE training course to
Taiwan, Hong Kong and oversea
•Public welfare activities, to strengthen the Association and
government communication,Such as Ouryao,CFDA…
•Development cooperation training programs with other associations
Financials：
•Make the training progress financially sound
•Generate 30% new ISPE members from the members attending each
course
Process：
Instructor/SME：
Process：
•Identify and develop courses that meet local market needs and
decide the training topics in 3 Y
•Drive educational programs
•Outreach the companies to identify needs for in-house training
•Develop on line training course
•Schedule to hold the quarterly training course in 2015
•Develop 12~15 Qualified Local instructors to cover 10 -12 topics by
the end of 2013
•Attract more volunteer as SME
Training course Market Potential planning in three Years’
• Actions
Market Potential planning
•Develop the 3 year’s China training plan and secure local trainer to cover hot topics by market and regulators
CFDA
•Support Regulators for industry survey, e.g. The status of using and validation of computer system, and input
advisory opinion
•Cooperation training program with other association and CCPIE, such as Ouryao,CCPIE
•Public welfare activities, to strengthen the Association and government communication by Seminar or mini
training course, start pilot from Shanghai, roll out to Zhejiang, Jiangsu province..
Build up reputation and
customize current
curriculum
•Build up ISPE training committee reputation by repeat and roll out old training course by qualified instructors,
open new course to promote new instructor.
•Customize current curriculum or create modules based on the China GMP practices by local instructors, make
it to be use case apply to cross training course
•2014 public training: (1) 3 training series to cover 6-10 topics; (2) pilot public training in new cities based on
the needs assessment (conducting survey among members, potentials & companies).
•Developing TCM training course
Customer Acquisition
•Collect the in-house and on line training needs through survey, interviews & targeted corporate meetings and
make recommendations for roll out in 2015.
•Customer:Top 300 enterprise
•Domestic: expand to Chengdu, Guangzhou
•Gang, Ao, Tai: Taiwan, Hong Kong/Macao
•Oversea: Malaysia, Indonesia, Korea
Instructor/SME
Qualification
•Review and improve the process of local trainer selection and application, e.g. for candidates who are not good
at oral English, the telephone interview could be changed to written test & rehearsal
2015 Training Plan
2015
Location
Course
Instructor
(T14) 制药设施的HVAC系统
Yang yixin
(T45) 计算机化系统合规性基本原理GAMP® 5 的应用-----包括附录11和
Lin hong
电子记录和电子签名
Before CIPM
14-15May 2015
July- Aug
QingDao
Shanghai
(T42) 质量风险管理
Li hongyang
(T40) 基于风险的调试与确认的现今方法
Ma yiling
(G07) GMP 审计
(T10) 固体口服制剂
Shen Qing
Lei Jifeng
(T46) 工艺验证生命周期—集成到制药质量体系 PV/PQS
Lei Jifeng
(G07) GMP 审计
Shen QIng
(T42) 质量风险管理
Li hongyang
(T40) 基于风险的调试与确认的现今方法
Ma yiling
(T10) 固体口服制剂
(T43) Turning QbD into a Practical Reality
践应用
Lei Jifeng
质量源于设计（QbD）的实
Tong Cheng
(T11) Practical Application of Computerized Systems Compliance:
Applying the GAMP® 5 Guide: A Risk-based Approach to Compliant
GxP Computerized Systems Level: Advanced - Application
Lin hong
(T26)Facility Project Management in the Regulated Pharmaceutical
Industry
TBD
计算机化系统合规性
GAMP 5&,Annex 11,Part 11
质量风险管理QRM
无菌Sterile
Life Sciences Industries
Bio-API
Chemical API
TCM
固体口服制剂OSD
调试与确认Q&C
GMP 审计Auditing of GMP
ISPE Training Course/ workshop held in 2014
21-24Jul
1. (T45) Basic Principles of Computerized Systems Compliance using GAMP®5,
Including Revised Annex 11 and Part 11 Update /计算机化系统合规性基本原理
GAMP® 5 的应用-----包括附录11和电子记录和电子签名
Course
Registrants
2. (G07) GMP Auditing for the Pharmaceutical Industry /GMP审计
1.(T45)
46
2. (G07)
24
3. (T10)
34
3. (T10) Oral Solid Dosage Forms: Understanding the Unit Operations, Process,
Equipment, and Technology for OSD Manufacture/口服固体制剂
21-24Jul
18-22Aug
18-22Aug
1. (T11) Practical Application of Computerized Systems Compliance--- Applying the
GAMP® 5 Guide: A Risk-based Approach to Compliant GxP Systems/ 计算机合
规实际应用
2. (T40) Science and Risk-based Commissioning and Qualification /调试与确认现今
方法
3. (T42) Applying Quality Risk Management (QRM)
1.(T11)
16
2. (T40)
15
3. (T42)
28
4. Pharmaceutical
Manufacturing Facility
Design Workshop
14
4. Pharmaceutical Manufacturing Facility Design Workshop/药品生产设施设计研讨会
13-14Nov
13-14Nov
1. (T14) Environmental Control And HVAC For Life Science Facilities /制药设施的
HVAC系统
1. (T14)
45
Total:
222
ISPE Training Committee
Name
Lin Hong
林洪
Xie Jingjun
谢京军
Wesker Xu
徐旻
Wu Jun
吴军
Designation
生命科学领域项目总监
Director Life Sciences Vertical from MES
中国合规和调试与验证高级专家
Senior specialist of compliance and
commissioning & qualification
SQA Compliance Auditor
供应商质量审核
Company
Siemens Industry Software( Shanghai )Co.,Ltd 西门子工业
软件（上海）有限公司
NNE Pharmaplan (Tianjin) Co.,Ltd
恩宜珐玛（天津）工程有限公司
Abbvie China
艾伯维 (中国)
GMP Self-employer
GMP 自由工作者
GMP 自由工作者
ZhuanSun Yan
颛孙燕
GMP检察员
GMP inspector
Center for Certification & Evaluation, SHFDA
上海市食品药品监督管理局认证审评中心
Zhang jinwei
张金巍
副总经理兼质量总监
Tasly（liao ning）vice-general manager
天津天士力（辽宁）制药有限公司
tasly pharmaceutical group Co.,Ltd.
Advisor
Name
Rory Budihandojo
Designation
Director, Quality Audit Unit, China
Company
Boehringer-Ingelheim Chemicals
Chair and Co-chair Roles
Chair & co-chair
– Develop committee
– Support accomplishment of committee annual
objectives
– Recommend potential candidates for future
Chair/Co-Chair positions
Co-chair
– Facilitate Committee Meetings and Teleconferences
when chair is absent
Committee member roles
Committee members
• Identify appropriate SMEs
• Lead SMEs of specific area for course localization
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discuss local needs of specific course
course customization
add case study
local instructor/facilitator
course materials translation and review
• Recommend local candidate instructors/ facilitators
Committee Member Expectations
• Be familiar with the Industry and the specific area defined
• Respect ISPE confidentiality agreement
– Always act in the best interest of ISPE
– Fully support all decisions of the Board and Committee
– Listen to people and ideas
• Time commitment
 Actively participate in meetings - can attend at least 8~9 times
regular monthly meeting per year
 Read materials and come prepared to each meeting
 Complete assignment on time
 Respond to communications in a timely manner