Event: Good Manufacturing Practice

Dates: July 10th & 11th, 2008

Venue: TBD, Shanghai, China

 

In China, all pharmaceutical/bio-tech/healthcare/animal health must comply with GMP (good manufacturing practice), which is governed by SFDA (State Food and Drug Administration) and CCCD (China certification Committee for Drugs). SFDA issued revised good manufacturing practice inspectional guidelines on Oct. 24, 2007 in an effort to increase quality systems standards for manufacturers. The new guidelines went into effect on Jan. 1, 2008, replacing the old GMP inspectional guidelines, which were implemented in 1998.

 

Besides, manufacturing is a strict and complicated production process itself. It requires high quality and safe production process. Many manufactures are weak in quality control, people training, and they are striving for effective manufacturing practice under government policy and maintaining high quality product as well.

 

2 days conference with 1 roundtable, 11 case studies plus 4 case studies.

 

Topics:

- Interpreting newly revised GMP standards and applying it in manufacturing 

- Analysing international GMP regulations for business improvement and   expanding

- Designing a streamlined equipment validation protocol to provide reliable

   hardware before routine use

- Strengthening technique validation to guarantee good product quality

- Carrying out optimised system validation plan to achieve excellent

   operation process

- Executing effective field management to improve output

- Monitoring workshop environment dynamically to keep manufacturing

   surroundings safe consistently

- Cultivating fitting workforce to empower your production management

- Supervising non-sterile product production process strictly to produce

   certified products

- Developing good engineering design to yield high- grade product

- Building up computerized system validation (CSV) to streamline

   documentation manipulation

- Performing robust quality risk supervision to operate manufacturing

   smoothly

- Implementing optimised deviation and change management to guarantee

   product quality

- Reducing costs and creating capital for growth in compliance with GMP

- Reinforcing raw material handling to yield good product

For more information or registration, please contact: