"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Ensure access to the Chinese market
Preparing, Participating and Handling a Chinese Food & Drug Administration (CFDA) Inspection
The Chinese Drug market is increasing fast – and the CFDA must ensure that any foreign company exporting medicinal product to China complies with the CFDA drug regulations and standards!
The CFDA’s 2016 drug inspection report indicated the performance of inspections in 19 countries, including 33 planned inspections in Europe. (http://eng.sfda.gov.cn/WS03/CL0757/173385.html). Pharmaceutical and medical device firms exporting products to China have seen an increasing focus on GMP compliance from the CFDA. The CFDA has published a draft guideline on overseas inspection of medical device companies in December 2017; therefore, the number of inspections will likely rise for medical device firms.
According to the CFDA drug inspection report, the focus of the CFDA is to find problems: "There's a worldwide understanding that if an authority can find more problems, it proves the agency is highly-qualified. Our role is to find problems. Our inspectors are trained to find more problems, and tell the industry to deal with them and prevent them to be found in the future," says Ding Jianhua, director of Department of Drug and Cosmetics Supervision of the CFDA.
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 inspector, 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 attendee 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.
Course content: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
- 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
- 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
- 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 production, etc.)
- Comparison with US and EU GMP requirements
- Examples: data integrity, validation, laboratory controls
- Statistics over the years
- Examples of CFDA issued citations
- Trending of CFDA citations
Who should attend:
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 product 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.
In the report, CFDA gives information about both domestic and overseas inspections and you can find examples of their findings as well. Overseas inspections covered 51 enterprises (mainly in Europe and North America) during 2017, a slight decrease compared to 2016. 9 of these inspections didn’t pass and the two major areas where defects were found was QA/QC and Document controls.
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Pharmaceuticals and Medical Device
Dr. Mel Dong
09.00-17.00 (Registration 08.30-09.00)
Register by 28 Aug: 6 330 DKK (€ 850)
and save 1 500 DKK (€ 200)
From 29 Aug: 7 830 DKK (€ 1 050)
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the seminar fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the seminar fee.
For groups registered and invoiced together for the same course we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
Quantity disconts can not be combined with other discounts or offers.
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.