Contact Us:+86-21-61573930  61573919     Add to Calendar    /    中文   /   English   

 
 
   
 

Your present position: > Agenda

Full agenda, please click here              More about speakers, please click here

  

Day One(6/11/2012)

 

9:00~10:30

 

New GMP certification and the application of the new standard

10:30~11:00

Coffee break and Networking

11:00~11:45

Analyzing current quality management system situation of drug manufacturers and improvement approaches

11:45~12:30

Validation Plan and Implementation of New GMP Practice

12:30~14:00

Luncheon and Networking

14:00~14:45

Implementation experience of New GMP and specific measures of quality management system

14:45~15:30

How to build a robust quality system for pharmaceutical product?

15:30~15:45

Coffee break and networking

15:45~16:30

Understanding manufacturing deviation and the implementation of corrective action and preventive action (CAPA)

16:30~17:00

Case study: document management challenges under the requirement of new GMP

  17:00~17:30

  Panel Discussion: Optimizing drug production quality management system through
multi-sectoral cooperation

    

Day Two(7/11/2012)

Track A: featuring sterile drug products

9:00~10:00

New GMP risk control requirements of sterile drug products and manufacturing process verification design

10:00~10:45

Understanding process requirements and verification of small volume injection production equipment

10:45~11: 00

Coffee Break and Networking

10:45~11:40

New GMP requirement for freeze drying manufacturing and improvement

11:40~12:10

Panel discussion: Real-life pharma manufacturers’ experience on passing new GMP compliance sterile drug products inspection

12:15~14:00

Luncheon and Networking

14:00~14:45

Concrete operations: how to build GMP compliance clean public system

14:45~15:30

Investigating sterile drug production verification and pollutant risk control

15:30~15:45

Coffee Break and Networking

15:45-16:30

Identifying key points of sterile drug products inspection

16:30~17:15

Investigating sterile drug production verification and microorganism risk control

 

 

Track B: API

9:00~9:45

Fully Understanding regulatory expectation of cGMP and inspectorss’ inspection priorities based on new regulatory climate

9:45~10:30

Highlighting the content of ICH-Q11 and its influence on API industry in China

10:30~10: 45

Coffee Break and Networking

10:45~11:30

Quality, cost, speed---three key factors to promote API export for Chinese API manufacturers

11:30~12:15

Panel discussion: Real-life API manufacturers’ experience on passing new GMP inspection

 

 

 

 

For speaking opportunities, please contact

 

Ms. April Pan 

Conference Producer

Email: april.pan@ubm.com

 Subscribe Enews Here

Organised by

Bronze Sponsor

Insertion Sponsor

Media Partners

 
Registration | FAQS | Download | Contact Us | About Us | Terms& Conditions | Privacy Policy  | Cookie Policy
Contact: Tel:+86-21-61573930 61573919 Fax:+86-21-61577299 Email:askconference@ubm.com Add:9F, Ciros Plaza, No.388 West Nanjing Road, Shanghai 200003
© Copyright ©UBM 2011-2012, All Rights Reserved