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Quality Management System and Risk Management

Sterile Drug Products

API

What practical measures have pharma manufacturers taken to implement new GMP?
What is the current situation of their progress?
What is the challenges and solutions of pharma manufacturing industry?

China's new GMP regulation has come into force on 1st March, 2011. There are only 154 out of 5000 pharmaceutical companies in China who has passed the new GMP inspection until the end of 2011. Those manufacturing sterile drug products such as blood products, vaccines and other injectable drug products will be required to comply by 31 December, 2013, while all other facilities will have until 31 December, 2015.

Over 5000 Chinese pharmaceutical companies are facing challenges in the context of "hardware and software"updates:
•How to understand the relations between the new GMP and drug quality management system?
•How to implement practical measures to build quality management system?
•How to deal with the deviation and change during production process?
•How to proceed with process verification on sterile drug products and improve quality?
•How to keep the balance between quality and cost?

The new GMP is focused on strengthening management, enhancing hardware requirements, encouraging quality and risk management innovation. It is more scientific, instructive and operable.  Pharmaceutical companies need to improve their production process, quality standard control and the verification techniques, especially in the aspects of sterile drug products, employee training and registration optimization.

Pharma Manufacturing & Quality Management China 2012 will gather 120+ decision makers from both government institutions and pharmaceutical companies to discuss hot topics including quality management system, API manufacturing, solid dosage form production and sterile drug products. It will provide a interactive communication platform for professionals in pharmaceutical industry to benchmark your business and technology against ‘best in class’ and ensure that you have the tools you need to form a coherent and logical strategy.

  Hot Topics
Quality Management System and Risk Management
Understanding the transformation of inspection — from understanding of formative clause to new GMP connotation
Understanding manufacturing deviation and the implementation of corrective action and preventive action (CAPA)
Comprehending product process and formulating optimum technical statistical analysis and quality management
Sterile Drug Products
Sterile drug product requirement updates in new GMP and improvement strategies for Chinese pharmaceutical companies
Optimizing process verification and quality improvement of sterile drug products complied with new GMP standards
Identifying and controlling the risk of freeze drying manufacturing process
API
Fully Understanding regulatory expectation of cGMP and inspectorss’ inspection priorities based on new regulatory climate
Navigating challenges in API registration for production synthesis process production
Utilizing new Chinese GMP inspection to promote API export
  Who Should Attend

CEO, VP, GM, Director, Head, Manager of
Manufacturing/ Facility/ Technical operation/ QA/ QC/ GMP Compliance/ Validation/ Process Development/ Equipment/ Engineering/ Registration/ Sales & Marketing/ Business Development

From
Pharmaceutical manufacturers/ Engineering company/ Equipment suppliers/ Instrument suppliers/ Technology providers/ Software providers/ CMO

  Why Pharma Manufacuturing is a ‘MUST ATTEND’?

100+ decision makers from phamaceutical manufacturers
20+ high-level speakers
8+ pharma manufacturing media partners
8+ hrs multi-style networking
4 panel discussions from GMP qualified pharma manufacturers
3 real-life case studies from leading pharma manufacturers
3 streams featuring solid dosage forms, sterile drug products, API

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