P-MEC Summit CHINA 2014

P-MEC Summit CHINA 2014

Module One: Pharma Manufacturing

Hall N3M43, June 26th 14:00-16:05

13:00-14:00

Registration

14:00-14:05

Address from Chairman

14:05-14:45

Building and Implementing effective Strategies and Plans for Expanding Production Capacity

• Analyzing the business drivers and the complexities of expanding capacities
• Utilizing existing manufacturing assets to meet growing product demand
• Identifying the best tools and practices to increase capacity wisely
• Driving change and efficiency and managing facility expansion
• Integrating and optimizing Supply chain network
• Ensuring Smart Supplier management

14:45-15:25

Moving from Batch Processing to Continuous Production

• The future of continuous manufacturing
• Exploring the benefits such as flexibility, cost and quality
• Minimizing the required size of new manufacturing plants, as well as efficiently utilizing the available capacity

15:25-16:05

Designing, Upgrading and Reforming Workshop Facilities

• Improving working efficiency
• Exploiting new equipment and process technologies for flexibility and quality
• Meeting regulatory requirement

16:05

The End of Module One

P-MEC Summit CHINA 2014

Module Two: Quality Management System

Hall N3M43, June 27^th 9:00-12:05

8:30-9:00

Registration

9:00-9:05

Address from Chairman

9:05-9:35

Assessing the Effectiveness of Internal Quality System by Utilizing Quality by Design Principles to Improve Manufacturing Efficiency

9:35-10:05

Optimizing Quality Management System by Setting Up Procedures, Incentive Mechanism and Implementing Document Management Training

10:05-10:35

Break, Networking & Visiting Exhibition

10:35-11:05

Guaranteeing Open Communication Lines between Manufacturing and Quality to Realize Operational Excellence

• How to form open communication lines
• Working together to ensure quality is involved when every manufacturing decision is made
• Driving an environment of quality for both manufacturing and QA through building clear and efficient communications

11:05-11:35

Actual Case Studies from Operational Level on Risk Assessment and Control

• Identifying critical process parameters (CPP) and critical quality attributes (CQA)
• Installing and reviewing risk management system regularly to ensure that a company stays within appropriate risk levels
• Mitigating quality manufacturing risks when expanding product capacity
• Clear communication of risk strategies to employees

11:35-12:05

Computer System Validation

12:05

The End of Module Two

P-MEC Summit CHINA 2014

Module Three: API GMP Inspections Training

Hall N3M43, June 28^th 9:00-12:00

Sessions

GMP Inspection Results Sharing from Different Provinces

Common Deficiencies Found during SFDA Inspections

Selection of API Manufacturing Facilities

Seeking the Right Balance Between Quality and Cost of Facility Reform

Creating and Maintaining A Site Inspection Readiness Profile

Preparing Your Facilities to Anticipate and Exceed the Expectations of the SFDA

Case Analysis

8:30-9:00

Registration

9:00-10:00

Training Program

10:00-10:10

Questions & Answers

10:10-10:50

Break, Networking & Visiting Exhibition

10:50-11:50

Training Program

11:50-12:00

Questions & Answers

12:00

The End of Module Three