Preparing, Participating & Handling a CFDA Inspection

Date: To be confirmed
Instructor: Dr. Mel Dong
Location: To be confirmed
Contact us for more information: bbc@bluebell-consulting.com

The Chinese market for drugs and medical devices is increasing fast – and the CFDA (currently, National Medical Products Administration, NMPA) must ensure that any foreign company exporting medicinal products to China complies with the CFDA drug and medical device regulations and standards!

The CFDA’s 2017 Drug Inspection Report indicated the CFDA performed 51 planned inspections in Europe (http://www.cfdi.org.cn/resource/news/2017pdf_en.html), increased from 33 planned inspections in Europe in 2016. Pharmaceutical and medical device firms exporting products to China have seen a rapid expansion of CFDA overseas inspection in number and expectation on GMP compliance. A CFDA Official announced early this year that the CFDA intended to orderly expand its overseas inspection programs and would further increase the number and intensity of overseas inspections in the coming years.

During this Seminar you will get the opportunity to hear from an expert in the field about the CFDA organization and regulatory authority, the CFDA inspection process and strategy, how to interact with the CFDA inspectors, and recommendations to prepare for a successful CFDA inspection. In addition, you will also hear from Industry colleagues about their CFDA inspection experiences.

This course provides the attendees with the essential information and recommendations to promote the preparation for, and to facilitate, a successful CFDA inspection and to avoid CFDA inspection pitfalls associated with cultural diversity.

Personnel within Pharmaceutical or Medical Device/IVD companies who are responsible for handling and/or participating in inspections from authorities, either in companies already selling to the Chinese market or those in the process of getting their products approved and where an inspection may take place in the future. Quality Assurance, GMP compliance and regulatory affairs professionals should also attend to gain the necessary information and knowledge to prepare for a successful CFDA inspection.

• CFDA Organization & Authority
  • Brief history of CFDA
  • Organization and structure of CFDA
  • CFDA Drug and Device inspection program and procedures
  • CFDA regulatory authority: domestic vs. foreign companies
  • CFDA regulatory actions: domestic vs. foreign companies
• Qualification of CFDA Inspectors
  • Education, training and experience requirements
  • Command of English language
  • Training programs available to, and/or provided to CFDA inspectors
  • Qualification requirements to perform foreign inspections
  • Comparison with FDA & EU inspectors
• Inspection Logistics, Formalities and Courtesy
  • Provide or offer assistance for travel arrangements; e.g., hotels, ground transportation
  • Proper reception of CFDA inspectors
  • Meals and entertainment for CFDA inspectors
  • Use of interpreters
  • Translation of documents
• CFDA Inspection Process
  • Inspection scheduling and planning (length of inspection, number of inspectors)
  • Preparing responses and documents to standard administrative questions or requests
  • CFDA inspection techniques (e.g., walk-through inspection, follow path of drug productionand medical device production, etc.)
• Review of Unique CFDA GMP requirements
  • Comparison with US and EU GMP requirements
• CFDA Foreign Inspection Focus
  • Examples: data integrity, consistent actual manufacturing and control practice with submitted or approved applications, laboratory controls with Chinese Pharmacopeia and other technical standards
    
• Current CFDA Foreign Inspection Trends & Statistics
  • Statistics and trends over the years
  • Examples of CFDA issued citations